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SASBIOSYNTH 1
General Information DESCRIPTIONS
SAS BIOSYNTH PVT LTD WHO-GMP CERTIFIED COMPANY located at BADDI-Himachal Pradesh (India) its corporate office at Rajarhat Road ,New Town , Kolkata . The company was established in 2005 by Mr.Soumen Dey , a qualified Pharmacist having a decade of experience in marketing and manufacturing of Pharmaceuticals. Manufacturing unit no.1. is situated at Nalagarh Baddi Highway, BADDI, Distt. Solan, Himachal Pradesh (India), no2. is at KALA AMB ,HIMACHAL PRADESH . Manufacturing facility includes dedicated Beta-Lactam & Non Beta-Lactam & Other Pharmaceutical production units. The manufacturing facility has state of the art manufacturing infrastructure (Tunnel Systems) for the production of Pharmaceutical dosage forms. In-house Quality Control Laboratories having state of the art equipments for testing the quality of pharmaceutical products at each stage of manufacturing. The Utility includes Heating Ventilation Air Conditioning System, Water Purification Systems, Water for Injection System, Steam Generation System, Filtered Nitrogen System, Filtered Compressed Air System, Boiler & Diesel Generators to support the manufacturing activities. The company has a team of highly qualified & experienced professionals who supervise, control and monitor the process & quality of its Pharmaceutical products at each stage of manufacturing.
Manufacturing Facility is ISO 9001-2000 and WHO-GMP certified.
SAS BIOSYNTH is licensed to manufacture, store and distribute for sale of Biological &
Non Biological Pharmaceutical preparations ,licensed by State Drug Licensing Authority-Himachal Pradesh (India).
Pharmaceutical Formulations covering different dosage forms are: 1) Injection (dry and liquid forms) including pre filled syringes 2) Eye/Ear Drops 3) Dry syrup 4) Liquid Syrup 5) Sterile & Non Sterile Ointment 6) Capsule 7) Sachets (Dry & Liquid) SAS BIOSYNTH has established its niche by virtue of the quality of its products, & are being marketed all over India & for exports. The factory is located on a total area of 93000 sq ft. The site is located at around 1 kilometer from Baddi towards the national highway.
SASBIOSYNTH 2
SAS BIOSYNTH was established in the year 2005. Since inception it’s basic thrust was providing quality pharmaceuticals at cost effective prices with total customer satisfaction. SAS BIOSYNTH’s products are well accepted & established all around the globe through valuable customers with its products registered with various multinational companies are being sent to most of the countries like Nigeria, Ghana, Kenya, Srilanka, Vietnam, Iraq, Jordan, Azerbaijan and some CIS countries to name a few.
TABLES OF CONTENTS
1. GENERAL INFORMATION
1.1 Approval Signature
1.2 Revision Summary
1.3 Brief Information about the Firm
1.4 Any other manufacturing Activities
1.5 Site Address with phone & fax
1.6 Formulations manufacture in the Plant
1.7 Use of outside Technical guidance
1.8 Description of Quality management
2. MANAGEMENT
2.1 Qualification, experience and responsibility of management
3 PERSONNEL
3.1 Organization Chart
3.2 Qualification, Experience and responsibility of Key Personnel
3.3 Training and their records
3.4 Health requirements
3.5 Personal hygiene
4 PREMISES
4.1 Site plan of Manufacturing Area
4.2 Nature of Construction and finishing
4.3 Ventilation Systems with Schematic diagram
4.4 Special area for handling Toxic drugs
4.5 Description of Water with Schematic diagram
4.6 Preventive maintenance program for premises
5. EQUIPMENT
5.1 Brief Information of the equipment used in the production and quality Control
department.
5.2 Description of planned preventive maintenance program and reporting system
SASBIOSYNTH 3
5.3 Qualification and calibration including recording system, system Validation.
6. SANITATION
6.1 Cleaning records of area and equipment
7. DOCUMENTATION
7.1 Arrangements for preparation revision and distribution of necessary
documentation for manufacturing.
7.2 Microbial control of air and water.
8. PRODUCTION
8.1 Brief description of production operation using Flow diagram , specifying the
important step and process parameters
8.2 Arrangements for handling materials like Raw materials and Packing materials
and release of the products.
8.3 Arrangements of handling rejected materials
8.4 General policy of Process Validation
9. QUALITY CONTROL DEPARTMENT
9.1 Description of Quality control Department and their systems
10. CONTRACT MANUFACTURING AND ANALYSIS
11. DISTRIBUTION COMPLANTS AND PRODUCT RECALL
12. SELF INSPECTION
13. STABILITY STUDIES
14. OUR VISION
15. QUALITY OPERATIONS
16. INSTALLED CAPACITY
Prepared By Checked by Approved by
Mr.K.S.Thakur B.K.ARSHAN B.K.RAJPUT
MANAGER AGM ( DGM-QA)
1. GENERAL INFORMATION
1.1 APPROVAL SIGNATURE
PREPARED BY SIGNATURE DATE
SASBIOSYNTH 4
Mr. K.S THAKUR
CHECKED BY SIGNATURE DATE
B. K .ARSHAN
APPROVED BY SIGNATURE DATE
B.K.RAJPUT
1.2 REVISION SUMMARY
Supersedes No. Effective Date Reason for Revision
Nil ………
1.3 BRIEF INFORMATION ABOUT THE FIRM
SASBIOSYNTH is promoted by an experienced vibrant team of Techno Commercial
Professionals with sound financial acumen. The Company has hands on experience in Pharma
trading & manufacturing.
The Directors of “SAS BIOSYNTH “are already in this field for many years.
Mr SOUMEN DEY Managing Director
The state-of-art-manufacturing facility is situated in Excise Free Zone-BADDI Distt. Solan
(Himachal Pradesh) & second plant in KALA AMB, HIMACHAL PRADESH India. Plant is WHO-
SASBIOSYNTH 5
GMP certified by the Drug authority of India. Productions team can satisfy customer
requirements for a wide range of products portfolio, meeting quality expectation & specification.
The electricity load sanctioned from the H.P.S.E.B is near about 1000KW.
All production activities have been drawn out to follow high standards of "Good Manufacturing
Practice" and in accordance with cGMP this state of art plant is geared up with latest fully
automatic production machineries from fame suppliers with high capacity and very high quality
norms.
A standard operating Procedure is being put into place which would be applicable to all
Departments and would be strictly enforced. Quality audits would be performed at regular
intervals by a self inspection team of representatives from quality assurance, production,
maintenance & HRD departments which would ensure that the Standard Operating Procedure is
being followed by all the employees.
“To practice GMP is our motto” is the punch line of “SAS BIOSYNTH”
1.4 ANY OTHER MANUFACTURING ACTIVITIES
No activities other than manufacturing of formulation dosage form are done.
1.5 SITE ADDRESS WITH PHONE & FAX
NAME AND EXACT ADDRESS OF FIRM
Corporate Office & works Office
Contact Person Designation MobileNo. Phone No.
Mr SOUMEN DEY Managing Director 09062331627 91-33-26434941
…..
At Factory
SASBIOSYNTH 6
Contact Person Designation MobileNo. FAX NO
Mr. B.K.RAJPUT DGM-QA 09903157775 91-33-6434941
Phone No. :-, 91-33-26434941
Website :- www.sasbiosynth.com
E-mail : [email protected]
1.6 FORMULATIONS MANUFACTURED IN THE PLANT
1. Capsules (Beta-Lactam & General)
2. Dry Syrup (Beta-Lactam)
3. Syrup & Suspension
4. Dry Injections
5. Liquid Injection (General & Hormonal)
6. Ophthalmic (Eye & Ear Drops)
7. Ointments
8. Creams
List of products attached (Annexure-II )
1.7 USE OF OUTSIDE TECHNICAL GUIDANCE
USE OF OUTSIDE SCIENTIFIC, ANALYTICAL AND OTHER TECHNICAL ASSISTANCE
Though the firm is fully equipped with all the instruments routinely required in the analysis, it
sends samples to the following Government approved laboratories for GC, IR etc. tests.
Chocksi Labs ITC Labs
Panchkula Panchkula
Haryana Haryana
1.8 SHORT DESCRIPTION OF QUALITY MANAGEMENT
1.8A
SASBIOSYNTH 7
We are committed to produce consistent quality products for winning global customers through
innovative quality pharmaceuticals products. We believe in development therapies and
processes and provide services of the highest value to nurture goods partnership with
customers. We shall endeavor to develop a well- defined system approach and to create an
environment of mutual respect, encouragement and teamwork.
1.8B
Responsibility of Quality Assurance.
Quality assurance dept. is functionally responsible for the implementation of all the CGMP and
current regular requirements which are listed below.
v To intiate corrective & preventive Acton with respect to product, process & system non
conformities
v Vender Qualification
v Final Approval of finished Product.
v Co-Ordination for the training of the Product.
v Self-Inspection.
v Validation of the equipment & system.
v Investigations of the market complaint.
v Review & approval of deviation and change control.
v Over all control of the document distribution.
v All specification, Testing methods, Sops, Batch records, Validation protocol approval by Q.A.
2. MANAGEMENT : 2.1 QUALIFICATION, EXPERIENCE AND RESPONSIBILITY OF MANAGMENT
Mrs. Jayeeta Dey ( B.Tech) GeneralManager (International Business)
Had a long experience in production and quality control. She looks after the daily production
activity, monthly production planning and coordination. She is also chairman of internal audit
committee and is also engaged in third party development.
Mr. B K Rajput ( B.Sc ) Dy.General Manager -QA
Is a Science Graduate and has Vast experiance in QC &QA . He looks after QC &QA activities
Mr. Sanjeev Goel General Manager Corp.
Is a Post Graduate and looks after day to day activities of the firm. He is responsible for smooth
running of the factory, looking after the new business, development, projects & marketing
SASBIOSYNTH 8
3. PERSONNEL:-
Staff with appropriate qualification and suitable experience is employed
3.1 Organization Chart :- ( Annexure –I)
3.2 Responsibilities of Key Personnel – ( Annexure-II)
3.3 TRAINING AND THEIR RECORDS
Newly recruited employees at SAS Biosynth are given brief orientation course on their role of
work and basic GMP training. Personnel working at the floor level are evaluated based on their
job assessment by their seniors. A proper document is being maintained.
Organization Chart
SASBIOSYNTH 9
Managing Director
GM
Mng. Regulatory
Affairs
Sr. Chemist Comp. Opr.
Production Mng.
Manager (Q.A.)
Q.A. Mng.
Q.A. Chemists
R & D Mng.
R & D Chemists
Q C Mng.
Q.C. Chemists
I.P.Q.C. Chemists
Micro Biologists
I . T. Mng.
H.R.D. Mng.
I.T. Associates
H.R.D. Associates
Asst. Prod. Mng.
manufacturing
Mfg. Line Supervisors
Mfg. Chemist
Diff. Line Supervisor
s
Packing Mng.
Supervisors Eng.
Eng. (Utility) Mng.
Commercial Purchase Mng.
House Keeping I/C
Receiving Dept.
Dispatch Dept. Incharge
Purchase Accounts & Excise
Dispatch Associates
Supervisors Reciving Associates
DGM
Store Clerks
Store Mng.
SASBIOSYNTH 10
PACKING SECTION
SASBIOSYNTH 11
Packing Manager
Packing Supervisor
(Ground Floor)
Line Inch. (1)
Ear/eye
Line Inch. (2)
Liquid Inj.
Packing Supervisor (1 st
Floor) Oncology
Packing Associates
Packing Supervisor (2nd Floor)
Line Inch. (1)
Line Inch. (2)
Line Inch. (3)
Packing Supervisor (3rd Floor)
Batch Printing Supervis
or
Batch Printing
Associates
Conveyer Line
Line Inch. 30ml Diclo Op.
Line Inch. 2ml Packing
Packing Associate
s
Packing Associate
s
Line Inch. (3)
Dry Powder
Inj.
Line Associates
Line Associates Line
Associates
Line Inch.
(4) Line Inch. (5)
Packing Associates
Packing Associates
Packing
Associates Packing
Associates
Packing
Associates
Line Inch.
Packing Associates
Blister-2 Op.
Blister-1 Op.
Line Inch. Line Inch.
Packing Associates
Packing Associates
Visual Insp. Sup.
Liquid, Powder,
Visual Associates
Prepared By Q.A. Manger
Approved By DGM (QA)
Authorized By G.M.Plant
Line Inch. (6)
Packing Associates
SASBIOSYNTH 12
Utility Department
Eng. (Utility) Manager
Supervisor Eng./
Maintenance
Elec. Associates
House Keeping In-
charge
RO/DW Plant
RO/DW Plant
Associates
Nitrogen/ Oxygen Plant
In-charge
Purchase In-charge
Receiving In-charge
Dispatch dept. In-charge
Mec. Associates
Cons. Associates
House Keeping Supervisor
House Keeping Associates
Cleaning/ Sanitation
Nitrogen/ Oxygen Plant
Associates
Purchase Associates
Receiving Associates
Dispatch dept.
Associates
Prepared By Q.A. Manger
Approved By DGM (QA)
Authorized By G.M.Plant
SASBIOSYNTH 13
Store Department
Store Manager
Store Supervisor Raw Material
Store Supervisor Packing material
Store Supervisor Quarantine (RM)
Prepared By Q.A. Manger
Approved By DGM (QA)
Authorized By G.M.Plant
Asst. Store Manager
Store Associates
Store Supervisor Allied Material
Store Associates
Store Associates
Store Associates
Store Supervisor Finished Material
Store Associates
SASBIOSYNTH 14
Maintenance Department
GM
Maintenance Mng.
Electrical Eng.
Jr. Eng.
Sr. Eng.
Sr. Wire Man
HTDG
Mechanics
Electronics
Eng.
Prepared By Q.A. Manger
Approved By DGM (QA)
Authorized By G.M.Plant
Sr. Eng.
Fitter
Fitter
Fitter
Fitter
Helper (Technical)
Helper (Technical)
Helper (Technical)
Helper
(Techni
Sr. Eng.
Fabricator
Plumber
Welder
Helper
Helper
Helper
Helper
Jr. Eng. Jr. Eng.
Wire Man
Wire Man
C/P Mechanics
Helper
Helper
L.T. Mechanics
Control Panel
Mechanics
Helper
Helper
SASBIOSYNTH 15
MATERIAL FLOW IN PROCESS – DRY POWDER INJECTION MANUFACTURING If not ok ok ok OK ok ok if not ok ok ok
Start Dispensed Vial, Rubber closure & seals
Vial / Rubber Closure Washing Sterilisation & Drying
Dispensing & Fabrication Under RLAF in Fabrication III
Sampling of blend by IPQA And registration of sample In Quality Control
Cleaning of the area And equipement for Line clearance
Vial Filling Bugning & Sealing Of The Vials
Recleaning of Area / Equipment
Control Sample
Release for sale By QAM
Transfer to BSR After IPQA Approval
Periodical Inprocess Inspection
Reinspection For line clearance
Quality Control Testing
Line Clearance
Line Clearance
Line Clearance
Start
Recording Of results in ROA
Clearance for Filling in BMR
Recleaning of Area / Equipment
Reinspection For line clearance
Recording In BMR
Certificate of Analysis
END
Batch Docket Auditing By QA
BMR / BPR
Periodical Inprocess Inspection
Vial Packing on Auto cartonner
Sampling for QC Analysis & Sterility testing
Vial labeling Optical Insp. Of sealed vials PM & BMR
SASBIOSYNTH 16
Process Flow chart Vial
R.M. Dispensing Bin Blending
Vial Washing Depyrogenation Nitrogen Filling
Bung Washing Sterilization Tunnel (Snowbell)
Bunging
Sealing Inspection Labeling Cartooning
Shrink Wrap Shipper Bopp Tapping & Coating
SASBIOSYNTH 17
MATRIAL FLOW IN WARE HOUSE Annexure:
Ok Not ok Rejected Ok
Start
Planning & Procurement Through Approved Vendor
Return Material to Supplier (Except Printed PMs)
Rejection of GRN
Rejection Note
End
Samplers Observatio
Termination of the Sampling of damage Containers
Reject Material, Preparation of rejection Note & rejected label
Inform supplier Transfer material in Rejected area
Destroy & records
Investigate & get Approval for destruction Information to QC
for Retesting
Retest due
End
Dispensing as per Bom
Storage of Material as per Recommended condition& Approved label pasting
Quality Control testing
Sample registration &AR Number allotment in QC
Receipt of GRN & Sampling Of the Material by QC, Pasting of sampled labels
Pasting of “UNDER TEST” label by W/H intimation to QC for Sampling
GRN
Receipt of material &preparation of Good receipts note
Quality Control testing
A.R.number wise Approved label
Generation
Records of Analysis
Certificate of analysis
Approval of GRN
Approval of the material In stock ledger
Accounts
Purchase
SASBIOSYNTH 18
Schematic Air Distribution
F .Air 675 CFM 4094 CFM 1712 CFM S. AIR
4094 CFM E. AIR 569 CFM 1037 cfm R Air Infiltration 70 Cfm
Schematic Air Distribution
Damper
Mixing chamber
Pre filter 20 Micron
Bag Filter 5 Micron
Microvee Filter 5 Micron
Cooling coil
Heating Coil
Fan
Terminal Filter 5 Micron
R A Filter 10 Micron
Damper
Mixing chamber
Pre filter 20 Micron
Bag Filter 5 Micron
Microvee Filter 5 Micron
Cooling coil
Heating Coil
Fan
Terminal Filter 5 Micron
R A Filter 10 Micron
Dry Powder Injection Filing
HVAC AIR DISTRIBUTIN DIAGRAM
DEDICATED AHU
SASBIOSYNTH 19
AIR 373 CFM 7646 CFM 7345 CFM AIR 4094 CFM 4074 CFM 3552 CFM
301 CFM 634 CFM 765 CFM 634 CF M 1138 CFM 644 CFM 654CFM 785 CFM 1156CFM 756 CFM 620 CFM 311 CFM 10 CFM 10 CFM 20 CFM 20 CFM 20 CFM 20 CFM INFILTRATION INFILTRATION INFILT. INFILT. INFILT. INFILT.
HAVC AIR DISTRIBUTION DIAGRAM COMBINRD AHU
SASBIOSYNTH 20
WATER SYSTEM
D.M.Water Solution Room Washing Deptt. Solution Room
Start
Tank Tank
Multi Column
Storage Tank
R.O.Plant
SASBIOSYNTH 21
Details of Q.A.Person
S No Name Qualification Experience 1 B. K Rajput B.Sc 21 year 2 Rajnish kumar B.Sc 1year 3 Ram Lal B.Pharmacy 6 months 4 Divesh Kumar M.Sc 6 months 5 Satya Narayan B.Sc 3.5 Year 6 Vijay Kumar Jha B.Sc 2 year 7 Niranjan Pardhan B.Pharma 5 months 8 Saubhagaya B.Pharmacy 3 months 9 Ashok Kumar Rao B.Sc 1 year
10 Pardeep Kumar Biotech Eng. 8 months 11 Dinesh Kumar B.Sc 2 months 12 Deepak Verma B Sc. 2 Year 13 Ajay Kumar M.Sc 4 Months 14 Ajay Kumar Graduaction B.A. 7 Months 15 Rajesh Sandhu B Sc. 10 Months
Details of Q.C.Person
S No Name Qualification Experience 1 Sanjeev Kumar B.Sc 3 years 2 Sanjeev Thakur B.Sc 2 years 3 Sudhir Sharma M.Sc 1.5 year 4 Surender Kumar M.Sc 2 year 5 Jitender Upadhya M.Sc 1 Months 6 Anupam Singh Rathore B.Sc 2.5 year 7 Isha Basin M.Sc 3.5 months 8 Ranjeet Kumar M. Sc 6.5 Months 9 Baby Arshi B.Sc B.Pharma 1.5 year
10 Raj Kumar B.Sc 5 Months 11 Manvinder Rana B.Sc B.Ed 7 Months 12 Ravinder Nath yadev B.Sc 1 year 13 Ritesh Sharma M.sc 5 Months 14 Anil Kumar M.sc 1 year 15 Sheetal Shah B.tak 1.5 Months 16 Jai Singh M.Sc 13 Months 17 Pooja B.Pharm, 2 years
M ECHANICAL S No Name Qualification Experience 1 Subhash Thakur Mech.Incharge 15 year 2 Som Parkash Foreman 30 year
SASBIOSYNTH 22
3 Sandeep Kumar Engg, B.Tech 4 year 4 Santosh Mech.Engg. 1.5 year 5 Nawab Singh Technical 11 year 6 Raju Technical 15 year 7 Ashok Kumar Welder 3 year 8 Dharambir Fitter 8 year 9 Roopam Sharma Fitter 10 Months 10 Santosh Pathak Fitter 2.5 Year 11 Naresh Pandey Fitter 3 Year 12 Shiv Lakhan Fitter 8 months 13 Baljeet Pannel Tek 2 year 14 Micky Welder 4 year 15 Harish Verma Fitter 1.6 year Electrical S No Name Qualification Experience 1 Vippan Rana Elect. Engg 3 year 2 Sumit Kumar Elect 4 year 3 Ashok kumar Elect. 2.6 year 4 Manoj Kumar Elect 3 year 5 Upender Singh A .C Mech 6 year 6 Vikram Singh I.T.I.Electration 8 Year 7 Chandan A/C Mech. 2 year 8 Rubal Singh Electrical Dip. 3 year 9 Anil Kumar Electrical Dip. 2.6 year 10 Sanjeev Kumar Electration 1 year
.
Department Dispatch S.No. Name Qualification Experience
1 Unni Krishnan B.Com 20 years 2 Devraj B.A. 4 Year 3 Sanjeev Kumar B.A. 1 year 4 Sweety B.C.A 8 Months 5 Shashi Kumar B.A. 2 Year 6 Harish Kumar B.A. 2.5 Year
SASBIOSYNTH 23
Department H.R.D S.No. Name Qualification Experience
1 Ravi Rana B.A.(P.G.Dip.) 11Years 2 Anoop Kumar B.A. 4 Year 3 Bimla Rana B.A. 2 Years 4 Suresh Kumar Sharma B.A. 1 Years 5 Bikram Singh +2 (B.T.I) 5 Months
Department (Admn) S.No. Name Qualification Experience
1 Brig. A J S.Behl (G.M.Admn) M.Sc. 50 Year 2 Kapil Kumar B.A. 5 Months
Department ( Purchase) S.No. Name Qualification Experience
1 Moti Lal B.Com,M.Phil 4 Year 2 Rajesh B.Com 5 years 3 Shekhar Pandey B.Com 5 years
SASBIOSYNTH 24
Annexure –II
Responsibilities Mrs.Jayeeta Dey (B.TECH ) GENERAL MANAGER (International Business)
q Production Planning and Co-ordination
q Inventory Control
q Process Validation
q Equipment Validation
q GMP Training
q Internal Audit
q Review and Approval of production and Quality control documentation for compliance
with GMP and GLP requirements
q Review and approval of product design and development
q Product Labeling
q Review of the control of the quality of starting material, intermediates and finished
product.
q Review of batch production and quality control records and relese of batches
q Review of stability data and shelf life of product.
q Regulatory affairs.
MR B K Rajput
( DGM)
Ø Laying down specification for incoming material, Intermediates and finished products.
Ø Preparation of testing protocols.
Ø Maintenance and calibration of equipment.
Ø Validation of test methods
Ø Test records
Ø Stability testing.
Ø Personal Training.
MR Sanjeev Thakur ( B.Sc)
( Quality Control Manager )
SASBIOSYNTH 25
Ø Control on starting material intermediate product and finished product.
Ø Production and control of productions are clearly specified in a written from and GMP
requirement are implemented.
Ø Quality Audit.
Ø Calibration and Validation .
Ø Handling of product complaints.
MR B. K Arshan (B. Pharma) ( Production Manager )
Ø Batch Preparation of tablets section.
Ø Training of workers.
Ø Checking of material dispensing.
Ø Supervision of washing area.
Ø Filling procedure.
Ø Documentation.
MR Rakesh Sharma (B. Pharm.) (Production Manager )
Ø Batch preparation of Ointment Section.
Ø Training of Workers.
Ø Checking of Material dispensing.
Ø Filling Procedure.
MR. Vader ( Production Manager )
Ø Batch preparation of Parental Section.
Ø Training of Workers.
Ø Checking of Material dispensing.
Ø Filling Procedure.
Ø Supervision of washing Area.
3.4 HEALTH REQUIREMENT FOR PERSONS ENGAGED IN PRODUCTIO N
All the employees of Company are subjected to Medical checked up by qualified Physicians
in regular intervals, at least once in a year. Relevant records are being maintained. Proper
care is being taken to see that the employees are not infected with any subject that leads to
contamination of products.
SASBIOSYNTH 26
3.5 PERSONNEL HYGIENE REQUIREMENTS INCLUDING CLOTHINGS
Workers are being provided with clean Aprons, Chappals and toher necessary uniforms to
work in the floor. Change rooms have been provided separately for Males and Females for
changes to be done. Wash basin is also provided inside the change room for proper
cleanliness.
4. PREMISES
4.1 SITE PLAN AND DESCRIPTION OF MANUFA CTURING AREA
Annexure -III
4.2 NATURE OF CONSTRUCTION AND FINISHING
Manufacturing Items Approx. Area (Sq.
Feet)
Construction
Beta Lactam
Injections
8000sq. feet RCC
Non Beta Lactam
Injections
8000 sq. feet RCC
Anti Cancer
Injections
6000 sq.feet RCC
Beta Lactum
Capsules, Dry
Syrups,
4000 sq. feet RCC
Beta lactam Dry
syrup
4000 sq.feet
Ophthalmics 6000 Sq. feet RCC
Liquid Syrup 8000 sq. feet RCC
Ointments 6000 sq.feet RCC
Quality Control 6000 sq.feet
Utility 10000 sq. feet RCC
Stores & Warehouse 15000 sq. feet RCC
Service Floors 12000 sq. feet RCC
SASBIOSYNTH 27
4.3 Description of HVAC SYSTEM
The heating ventilation and air conditioning ( HVAC) system is designed to supply clean
and conditioned air to manufacturing area, Appropriate pressure differential is
maintained in all the Area. Process area and passage are pressurized positively with
respect to ambient environment in order to prevent cross contamination .Terminal HEPA
filters are installed in all processing area where filling & sealing of the product is done
under laminar air flow workstation i.e. in class 100 area.
The HVAC system is designed to provide temperature and humidity as required by
various process and products.
Annexure –IV
Annexure-IV
AIR CLASSIFICATION SYSTEM FOR MANUFACTURE OF STERILE PRODUCTS. Grade Maximum No. of Permitted particles
per cubic meter equal to above.
Maximum No. of Viable
Microorganism permitted per cubic
meter of air.
0.5 – 5 u Ø 5 u A
( Class –100)
Laminar Air Flow Work
Station.
100 at rest &
3500 in
operation
None Less Than 1
B
(Class –100)
3,500 None 5
C
(Class –10,000)
3,50,000 2,000 100
D
( Class-10,0000)
3,500,000 20,000 500
§ In Order to reach class 100,10,000 in 100,000 in clean levels, the number of air
changes shall be related to the size of the equipment & the personnel present in the
room.
§ The requirement & limit for the area shall depend on the nature of operation carried out.
Type of Operations to be carried out of the Various Grades for Aseptic Preparations
Class Type of Aseptic Operations
100 ( Grade A& B) Aseptic Preparation & Filling.
SASBIOSYNTH 28
10,000( Grade C) Handling of Components after weighing.
1,00,000( Grade D ) Washing.
Air Changes are designed according to the nature of operation in different areas.
4.4 SPECIAL AREA FOR HANDLING OF TOXIC MATERIALS
NOT APPLICABLE
4.5 BRIEF DESCRIPTION OF WATER SYSTEM WITH SCHEMATIC DIAGRAM
Raw water is being fed to the Demineralization water plant. The free chlorine levels of
the feed water are maintained in the range of 0.5 to 2.0 ppm to take care of the
microbial counts. The reservoir and overhead tanks are being cleaned as per the SOP in
regular intervals. The distribution of treated DM water is in complete stainless steel
SS316 & electro polished pipeline with triclover joints and heat tracer's loop system, to
make the product meet the required standards. DM water after examination for
compliance against the specification is used for the manufacturing. Of RO water & RO
water is fed to multicolumn distillation plant to manufacture Water for Injection. In
multicolumn plant which is stored in SS316 electrically heated tanks from where through
loop system WFI is given to different injection manufacturing sections as well as washing
of containers. The distribution of treated WFI is in complete stainless steel SS316 &
electro polished pipeline with triclover joints and heat tracer's loop system, to make the
product meet the required standards.
SAND BED COLUMN, ACTIVATED CARBON COLUMN , CATION & ANION EXCHANGE
COLUMN DEGASSING UNIT, MIXED RESIN BED WITH 5 micron FILTERS AND 0.2 micron
FILTERS WITH UV LAMPS.
4.5.1 The production of DM water involves the cleaning for column and regeneration of
the same.
4.5.2 All the columns are cleaned by back flushing, taking care that the packing of
column is not disturbed. Carbon column are sanitized by steam.
4.5.3 DM water flowing out of the system is monitored for its conductivity measured by
the conductivity meter. UV lamp is connected on line to reduce the microbial load. The
DM Plant has a circulatory loop line system to maintain the flow of water. All the
connecting pipes made of SS is being sanitized in regular interval as per the SOP with
steam.
SASBIOSYNTH 29
4.6 PREVENTIVE MAINTENANCE OF THE PREMISES
The house keeping team is given the charge to make the premises clean and tidy. An
experience supervisor takes the lead with his experience and makes sure that the
premises are always clean. The same team takes care of Pest control on regular basis
and keeps the cleaning records as per the procedure mentioned in the SOP. The house
keeping staffs are given training in regular intervals as per the cGMP norms.
SASBIOSYNTH 30
5. EQUIPMENT :
5.1 DETAIL OF MACHINERY USED IN THE UNIT. LIQUID SECTION
Sr No.
Machine/equipment description
1. Automatic Washing, Filling, Sealing,Inspection&Labelling Machine(96bpm Washing, 6 Head Filling &6 Head Sealing &Wet Glue Labelling) Gmp Model
2. Automatic Liquid manufacturing plant of capacity 3000 Lts with 3000 Lts capacity storage tank with homogeniser, bucket filter,filter press,transfer pump etc.
3. Transfer trolly 24”x 30”, GMP model
4. Bottle transfer trolly, GMP model
OINTMENT SECTION STERILE Sr No. Machine/Equipment
Description 1. Ointment Manufacturing Plant 500 Kg Capacity ,
GMP Model 2. Ointment Filling, Sealing & Coding Machine,Model SAU1
GMP Model OINTMENT SECTION NON STERILE
Sr No. Machine/Equipment Description
1. Ointment Manufacturing Plant 1000 Kg Capacity , GMP Model
2. Ointment Filling, Sealing & Coding Machine,Model SAU1 GMP Model
CAPSULE SECTION ( BETALACTUM)
Sr No. Machine/Equipment Description
1. Double Cone Blender 150 Kg, GMP Model
2. Vibro Sifter 30”, GMP Model 3. Semi- Automatic Capsule Filling Machine-CAPFILL(single loader) alongwith
vaccum pump & change parts, GMP model
SASBIOSYNTH 31
DRY SYRUP SECTION
Sr No. Machine/Equipment Description
1. Semi Automatic Air Jet Washing Machine, GMP Model 2. Automatic Single Head Auger Type Powder Filling Machine With One Parts,
GMP Model +Change Parts +Turn Table 30” Dia
3. Semi Automatic Ropp Cap Sealing Machine,Model LRSCS 40 Alongwith One Set Of Required Change Parts, GMP Model +Extra Change Parts +Spare Parts
4. Automatic Labeling Machine Model-BS40( Table Top Model) With One Set Of Required Change Parts,
INJECTION SECTION:
GROUND FLOOR
S.No. NAME OF MACHINE MODEL NO. CODE NO. MFD. BY
1 VAIL WASHING M/C LINEAR AHLVW-250 GF-001 AMBICA ENG.
2 VAIL WASHING M/C ROTERY ARVW-150 GF-002 AMBICA ENG. 3 AMPOULE WASHING M/C (JET) AFS-16 GF-003 UNITED ENG. 4 AMPOULE WASHING M/C (MANUAL) AWM-350 GF-004 UNITED ENG. 5 VIAL WASHING M/C LEANER ALVW GF-05 AMBICA ENG. 6 D.H.S. (A) DMP-51 GF-51 INDO GERMAN 7 D.H.S. (B) OMP-51 GF-007 OSHO ENG. 8 D.H.S. © OMP-31 GF-008 OSHO ENG. 9 AUTO CLAVE 3x3x4 GF-009 INDO GERMAN
10 DRY POWDER FILLING & SEALING M/C NKPF-125 GF-010 N.K. ENG. 11 DRY POWDER FILLING & SEALING M/C NKPF-250 GF-011 N.K. ENG. 12 VIAL FILLING & SEALING MACHINE LACKS-200 GF-200 LAXMI ENG. 13 VIAL FILLING & SEALING MACHINE VFM-150 GF-013 BHOLE ENG. 14 VIAL FILLING & SEALING MACHINE FPC-120 GF-014 DESHERA TECH 15 AMPOULE FILLING M/C AFS-8 GF-015 UNITED ENG. 16 AMPOULE FILLING M/C AFS-4 GF-4 UNITED ENG. 17 VIAL FILLING & SEALING MACHINE LACS-200 GF-017 LAXMI ENG. 18 SALUTION TANK ( homogeniser) ST-1200 GF-1200 FOOD PHARMA 19 SALUTION TANK ( homogeniser) ST-500 GF-019 FOOD PHARMA 20 SALUTION TANK ( homogeniser) ST-500 GF-020 FOOD PHARMA 21 SALUTION TANK ( homogeniser ) ST-500 GF-021 FOOD PHARMA 22 PRESSURE VESSEL PV-200 GF-022 FOOD PHARMA 23 PRESSURE VESSEL PV-100 GF-023 FOOD PHARMA
24 WEIGHING BALANCE ( STORE) EWB-10 GF-10 MODERN EQUIP.
25 WEIGHING BALANCE ( STORE) EWB-10 GF-10 MODERN
SASBIOSYNTH 32
EQUIP. 26 STICKER LABELING M/C ASAL-250 GF-026 N.K. ENG. 27 STICKER LABELING M/C ASAL-250 GF-027 N.K. ENG.
28 CARTON PACKING M/C CPM-125 GF-028 SHERMAX PACK.
29 VISUAL INSPECTION TABLE M/C No. 07 GF-029 SNOWBELL
30 AIR COMPRESSURE TFT-150-B9 HG-030 ANEST AWATA
31 AIR COMPRESSURE TFT-150-B9 GF-031 ANEST AWATA
32 D.G. SET 125Kva DG-125 GF-032 SUDHIR & CO. 33 D.G. SET 320Kva DG-350 GF-033 SUDHIR & CO. 34 OXIZEN PLANT PSA-02 GF-34 MVS ENG.
35 NITROZEN PLANT PSA-N2 GF-035 MVS ENG.
36 DEMINRELISED WATER PLANT CA-150 GF-036 ION EXCHANGE 37 SOFT WATER PLANT SWP-100 GF-037 ION EXCHANGE 38 EFLUENT TREATMENT PLANT ETP-1000 GF-038 WOCK OLIVER 39 BOILER RXA-200 GF-039 THERMAX 40 DEMINRELISED WATER PLANT CA-150 GF-040 ION EXCHANGE 41 SHRINK PACK TUNNEL LHS-115 GF-041 SHRINK ENG 42 SHRINK PACK TUNNEL LHS-115 GF-042 SHRINK ENG 43 BUNG WASHING M/C VARTICAL GF-043 INDO GERMAN 44 LAMMINAR AIR FLOW 3x6 4x4 GF-044 THERMADYNE 45 LAMMINAR AIR FLOW 4x4 3x6 GF-045 THERMADYNE 46 LAMMINAR AIR FLOW 3x10 GF-046 THERMADYNE 47 LAMMINAR AIR FLOW 3x6 GF-047 THERMADYNE 48 LAMMINAR AIR FLOW 4x4 GF-048 THERMADYNE 49 LAMMINAR AIR FLOW 4x4 GF-049 THERMADYNE 50 LAMMINAR AIR FLOW 4x4 GF-050 THERMADYNE 51 LAMMINAR AIR FLOW 4x4 GF-051 THERMADYNE 52 LAMMINAR AIR FLOW 3x10 GF-052 THERMADYNE 53 CONVEAR BELT 15 FIT GF-053 LAXMI ENG. 54 CONVEAR BELT 15 FIT GF-054 LAXMI ENG. 55 CONVEAR BELT 10 FIT GF-055 LAXMI ENG. 56 TURN TABLE 32 INCH GF-056 LAXMI ENG. 57 TURN TABLE 32 INCH GF-057 BHOLE ENG. 58 TURN TABLE 32 INCH GF-058 BHOLE ENG. 59 TURN TABLE 32 INCH GF-059 BHOLE ENG. 60 SHRINK PACK TUNNEL LHS-115 GF-060 SHRINK ENG 61 BOX PACKING M/C FXJ-6050 GF-061 BROTHERS 62 VISUAL INSPECTION TABLE 2 SIDES GF-062 BHOLE ENG.
63 WEIGHING BALANCE (PACKING) EWB-30 GF-063 MODERN EQUIP.
64 WEIGHING BALANCE ( PACKING) EWB-30 GF-064 MODERN EQUIP.
65 ELECTRIC CONTROL PANEL ECP-630 GF-065 SHIVAM IND. 66 LAMMINAR AIR FLOW 4x3, 8x3 GF-066 THERMADYNE 67 LAMMINAR AIR FLOW 4x3, 8x3 GF-067 THERMADYNE 68 FLY KILLER (1) 2 FIT 40W GF-068 PHILIPS 69 FLY KILLER (2) 2 FIT 40W GF-069 PHILIPS 70 FLY KILLER (3) 2 FIT 40W GF-070 PHILIPS 71 FLY KILLER (4) 2 FIT 40W GF-071 PHILIPS 72 FLY KILLER (5) 2 FIT 40W GF-072 PHILIPS
SASBIOSYNTH 33
73 PRESSURE VESSEL PV-100 GF-073 INDO GERMAN 74 PRESSURE VESSEL PV-100 GF-074 INDO GERMAN 75 PRESSURE VESSEL PV-100 GF-075 INDO GERMAN 76 VIAL FILLING MACHINE ( MANUAL) VFM-20 GF-076 LAXMI ENG. 77 TURN TABLE 32 INCH GF-077 LAXMI ENG. 78 TURN TABLE 32 INCH GF-078 LAXMI ENG. 79 TURN TABLE 32 INCH GF-079 LAXMI ENG. 80 TURN TABLE 32 INCH GF-080 LAXMI ENG. 81 PASS BOXES 5 Nos 2x2 GF-081 FOOD PHARMA 82 MEMBRANE HOLDER 16 INCH GF-082 INDO GERMAN 83 DISPENSING STATION GF-083 THERMADYNE 84 TRANSFORMER GF-084 85 C T V T GF-085 86 SS TROLLYE GF-086 87 FIRE EXICUTER (CO2) 1 Nos FE-50 GF-087 NATIONAL FIRE 88 FIRE EXICUTER (CO2) 2 Nos FE-05 GF-088 NATIONAL FIRE 89 FIRE EXICUTER (ABC) 2 Nos EF-05 GF-089 NATIONAL FIRE 90 RACK (STORE) GF-090 91 RACK (STORE) GF-091
92 AIR CARTAIN ( ENTERENCE) 3 FIT GF-092 VITZUA CARTAINS
93 AIR CARTAIN ( ENTERENCE) 4 FIT GF-093 VITZUA CARTAINS
94 AIR CARTAIN ( ENTERENCE) 3 FIT GF-094 VITZUA CARTAINS
95 AIR CARTAIN ( RECEPTION) 5 FIT GF-095 VITZUA CARTAINS
FIRST FLOOR
S.No. NAME OF MACHINE MODEL NO. CODE NO. MFD. BY
1 AIR HANDLING UNIT AHU-5000 FF-001 WAVES 2 AIR HANDLING UNIT AHU-1200 FF-002 WAVES 3 AIR HANDLING UNIT AHU-3650 FF-003 WAVES 4 AIR HANDLING UNIT AHU-1100 FF-004 WAVES 5 AIR HANDLING UNIT AHU-750 FF-005 WAVES 6 AIR HANDLING UNIT AHU-2655 FF-006 WAVES 7 AIR HANDLING UNIT AHU-1850 FF-007 WAVES 8 AIR HANDLING UNIT AHU-4000 FF-008 WAVES 9 AIR HANDLING UNIT AHU-3455 FF-009 WAVES
10 AIR HANDLING UNIT AHU-6220 FF-010 WAVES 11 AIR HANDLING UNIT AHU-1100 FF-011 WAVES
12 DEHUMIDIFIER 10 KW FF-012 FALICITY EQUIP.
13 ANALITICAL WEIGHING BALANCE AX-200 FF-013 SHIMADZU 14 STICKER LABELING M/C ASAL-250 FF-014 N.K. ENG. 15 WATER COOLER SYSTEM BDRM-1 FF-015 BLUE STAR 16 VIAL FILLING M/C VFM-150 FF-016 BHOLE TECHNO 17 VIAL SEALING M/C VSM-150 FF-017 BHOLE TECHNO 18 VIAL WASHING M/C VWM-150 FF-018 HBPL BADDI 19 AIR HANDLING UNIT AHU-800 FF-019 WAVES
SASBIOSYNTH 34
20 AIR HANDLING UNIT AHU-1350 FF-020 WAVES 21 AIR HANDLING UNIT AHU-450 FF-021 WAVES 22 AIR HANDLING UNIT AHU-1200 FF-022 WAVES 23 AIR HANDLING UNIT AHU-1350 FF-023 WAVES 24 AIR HANDLING UNIT AHU-400 FF-024 WAVES 25 AIR HANDLING UNIT AHU-2655 FF-025 WAVES 26 UV. SPECTROPHOTOMETER SL-160 FF-026 ELICO 27 TOP LOADING BALANCE BL 220H FF-027 SHIMADZU
28 PH. METER ( DIGITAL) FF-028 POPULAR ( AMBALA)
29 PH. METER ( DIGITAL) FF-029 MICROCSIL INDIA
30 CONDUCTIVITY METER FF-030 MAX ELECT. CHD.
31 K.F.TITRATOR MATIC-MD FF-031 VEEGO
32 MELTING APPARATUS FF-032 POPULAR ( AMBALA)
33 REFRECTRO METER FF-033 POPULAR ( AMBALA)
34 MUFFEL FURNACE ( DIGITAL) FF-034 POPULAR ( AMBALA)
35 WATER BATH ( DIGITAL FF-035 POPULAR ( AMBALA)
36 CERCULATING APPRATUS ( DIGITAL) FF-036 POPULAR ( AMBALA)
37 MAGNETIC STIRRER ( WITH HOT PLATE) FF-037
POPULAR ( AMBALA)
38 VACCUME OVEN ( DIGITAL) FF-038 POPULAR ( AMBALA)
39 FLOW CUP VISCOMETER FF-039 POPULAR ( AMBALA)
40 HOT AIR OVEN ( DIGITAL) FF-040 OSHO BADDI 41 TLC KIT ( WITH UV CABNET) FF-041 OSHO BADDI 42 REFRIDGERATOR FF-042 GODREGE 43 HPLC 2487 FF-043 WATER
44 WATER DISTILATION FOR HPLC FF-044 SARTHAK SCINTI.
45 HOT AIR OVEN ( 2) FF-045 SARTHAK SCINTI.
46 ULTRA SONIC BATH FF-046 SARTHAK SCINTI.
47 AUTO CLAVE ( VARTICAL) FF-047 OSHO BADDI 48 INCUBATOR 250'C FF-048 OSHO BADDI 49 INCUBATOR 35'C FF-049 OSHO BADDI 50 LAMMINAR AIR FLOW FF-050 THERMADYNE 51 LAMMINAR AIR FLOW FF-051 THERMADYNE
52 COLONY COUNTER ( DIGITAL) FF-052 SARTHAK SCINTI.
53 DRY BLOCK INCUBATOR FF-053 EQUICHEM 54 HOT AIR OVEN 2 FF-054 OSHO BADDI 55 MICROSCOPE FF-055 LABOMED 56 REFRIDGERATOR FF-056 VOLTAS
57 HOT PLATE FF-057 POPULAR ( AMBALA)
58 MICRO PIPETTE 10qL - 100qL FF-058 HIMEDIA 59 MICRO PIPETTE 10qL - 100qL FF-059 HIMEDIA
SASBIOSYNTH 35
60 FLY KILLER 2 FIT 40W FF-060 PHILIPS 61 FLY KILLER 2 FIT 40W FF-061 PHILIPS 62 FLY KILLER 2 FIT 40W FF-062 PHILIPS 63 VIAL SEALING M/C (simla kalka) FF-063 FF-063 LAXMI ENG. 64 VISUAL INSPECTION TABLE 5 FIT FF-064 BHOLE TECHNO
SECOND FLOOR
S.No. NAME OF MACHINE MODEL NO. CODE NO. MFD. BY
1 TUNNEL FT-900 SF-001 FABTECH ENG. 2 VIAL WASHING M/C AHL-200 SF-002 AMBICA ENG.
3 DRY POWDER FILLING M/C NKPF-250D SF-003 N.K. ENG.
4 VIAL SEALING M/C NKCS-350 SF-004 N.K. ENG. 5 TUNNEL 57-900 SF-005 SNOWBELL 6 VIAL WASHING M/C RVWM-300 SF-006 SNOWBELL 7 DRY POWDER FILLING M/C PVFB-240 SF-007 SNOWBELL 8 VIAL WASHING M/C SF-008 SNOWBELL 9 AMPOULE WASHING M/C FZZ0688 SF-009 FABTECH ENG.
10 TUNNEL FT-400 SF-010 FABTECH ENG. 11 AMPOULE FILLING & SEALING M/C SF-011 FABTECH ENG.
12 CONE BLANDER CB-200 SF-012 FOOD & PHARMA
13 GUM LABELING MC/ KHL-250 SF-013 KONARK (N.P) 14 GUM LABELING MC/ KHL-250 SF-014 KONARK (N.P) 15 STICKER LABELING M/C ASAL-250 SF-015 N.K. ENG. 16 STICKER LABELING M/C ASAL-250 SF-016 N.K. ENG. 17 STICKER LABELING M/C ASAL-250 SF-017 N.K. ENG. 18 SHRINK TUNNEL LHS-115 SF-018 SHIRNK ENG. 19 SHRINK TUNNEL LHS-115 SF-019 SHIRNK ENG. 20 SHRINK TUNNEL KHS SF-020 SHIRNK ENG. 21 SHRINK TUNNEL LHS-115 SF-021 SHIRNK ENG. 22 SHRINK TUNNEL LHS-115 SF-022 SHIRNK ENG. 23 CODE PRINTING M/C CPM-3600 SF-023 SATISH ENT. 24 CODE PRINTING M/C CPM-3600 SF-024 SATISH ENT. 25 CODE PRINTING M/C CPM-3600 SF-025 SATISH ENT. 26 CODE PRINTING M/C CPM-3600 SF-026 SATISH ENT. 27 AUTO CODING M/C ACM-200 SF-027 GOPAL ENG. 28 AUTO CODING M/C ACM-200 SF-025 GOPAL ENG.
29 ELEC. WEIGHING BALANCE EWB-300g SF-029 MODERN EQUIP.
30 HOT AIR OVEN 1.5x2.00 SF-030 VIKRANT EQUIP.
31 AMPOULE INSPECTION M/C SMPL-AIM-04 SF-031 SNOWBELL
32 AMPOULE INSPECTION M/C SMPL-AIM-06 SF-032 SNOWBELL
33 BOX PACKING M/C FXJ.-6050 SF-033 BROTHERS
34 AMPOULE LABELING (GUM) M6-012-6-05 SF-034 UNITED ENG.
35 AMPOULE LABELING (GUM) BM4-M-05 SF-035 BHOLE TECHNO
SASBIOSYNTH 36
36 CONVER BELT 15-FIT SF-036 BHOLE TECHNO 37 CONVER BELT 15-FIT SF-037 BHOLE TECHNO 38 CONVER BELT 15-FIT SF-038 BHOLE TECHNO 39 CONVER BELT 15-FIT SF-039 LAXMI ENG. 40 CONVER BELT 15-FIT SF-040 LAXMI ENG. 41 CONVER BELT 15-FIT SF-041 LAXMI ENG. 42 CONVER BELT 15-FIT SF-042 LAXMI ENG. 43 TURN TABLE 28" SF-043 LAXMI ENG. 44 TURN TABLE 28" SF-044 LAXMI ENG. 45 TURN TABLE 28" SF-045 LAXMI ENG. 46 LAMMINAR AIR FLOW 4x4, 6x4 SF-046 LAXMI ENG. 47 LAMMINAR AIR FLOW 10x3 SF-047 THERMADYNE 48 LAMMINAR AIR FLOW 10x3 SF-048 THERMADYNE
49 PASS BOXES 4 Nos 2x2 SF-049 FOOD & PHARMA
50 MEMBRANE HOLDER 16" SF-050 INDO GERMAN 51 DISPENSING STATION SF-051 THERMADYNE
52 SS TROLLYE SF-052 FOOD & PHARMA
53 FIRE EXICUTTER---3nOS FE-05 SF-053 NATIONAL FIRE
Third Floor
S.No. NAME OF MACHINE MODEL NO. CODE NO. MFD. BY
1 MULTI COLUME DISTILATIOIN PLANT MCD-120 TF-001 INDO GERMAN 2 VIAL FILLING M/C 8 HEAD LACS-250 TF-002 LAXMI ENG. 3 VIAL SEALING M/C 8 HEAD LACS-250 TF-003 LAXMI ENG. 4 CONVER BELT 15 FIT TF-004 LAXMI ENG. 5 CONVER BELT 15 FIT TF-005 LAXMI ENG. 6 SALUTION TANK ( HOMONISER) ST-500 TF-006 INDO GERMAN 7 SALUTION TANK ( HOMONISER) ST-500 TF-007 INDO GERMAN 8 SALUTION TANK ( HOMONISER) ST-300 TF-008 INDO GERMAN 9 PRESSURE VESEL PV-100 TF-009 INDO GERMAN
10 PRESSURE VESEL PV-100 TF-010 INDO GERMAN 11 VISUAL INSPECTION TABLE 4 FIT TF-011 BHOLE ENG. 12 STICKER LABELING M/C ASAL-250 TF-012 N.K. ENG. 13 TURN TABLE 32 INCH TF-013 LAXMI ENG. 14 BUNG WASHING M/C SN-629 TF-014 INDO GERMAN
15 FILLING TANK (30ML) FT-100 TF-015 FOOD & PHARMA
16 VIAL WASHING M/C ( ROTERY) ARVW-200 TF-016 AMBICA ENG. 17 TURN TABLE 32 INCH TF-017 BHOLE ENG. 18 BLISTER PACK INJ. 02 TF-018 GLOBEL ENG. 19 BLISTER PACK INJ. 02 TF-019 GLOBEL ENG. 20 BLISTER PACK INJ. 02 TF-020 GLOBEL ENG. 21 WATER COOLER WC-50 TF-021 OSHO TECHNO 22 WATER COOLER WC-50 TF-022 OSHO TECHNO 23 AMPOULE LABELING M/C BALM-250 TF-023 BHAWANI
SASBIOSYNTH 37
24 AMPOULE LABELING M/C BALM-250 TF-024 BHAWANI 25 AMPOULE LABELING M/C BALM-250 TF-025 BHAWANI 26 VISUAL INSPECTION TABLE 4 FIT TF-027 BHOLE ENG. 27 VISUAL INSPECTION TABLE 3 FIT TF-028 BHOLE ENG. 28 VISUAL INSPECTION TABLE 3 FIT TF-029 BHOLE ENG. 29 VISUAL INSPECTION TABLE 2.5 FIT TF-030 BHOLE ENG. 30 SHINK TUNNEL LHS-115 TF-031 SHINK ENG. 31 SHINK TUNNEL LHS-115 TF-115 SHINK ENG. 32 CONVER BELT 15 FIT TF-033 LAXMI ENG. 33 CONVER BELT 15 FIT TF-034 LAXMI ENG. 34 CONVER BELT 15 FIT TF-035 LAXMI ENG. 35 CONVER BELT 15 FIT TF-036 LAXMI ENG. 36 CONVER BELT 15 FIT TF-037 LAXMI ENG. 37 AMPOULE TRAY PACKING M/C ATP-15 TF-038 CHITAN IND. 38 CONVER BELT 10 FIT TF-039 BHOLE ENG.
39 DEHUMIDIFIRE 12 KW TF-040 FALICITY EQUIP.
40 DEHUMIDIFIRE 8 KW TF-041 BRY AIR TECHNO
41 STICKER LABELING M/C ASAL-250 TF-042 N.K. ENG. 42 VISUAL INSPECTION TABLE 2 SIDED TF-043 BHOLE ENG. 43 TURN TABLE 32 INCH TF-044 LAXMI ENG. 44 CONVER BELT 10 FIT TF-045 BHOLE ENG. 45 VIAL WASHING M/C ( ROTERY) ARVW-200 TF-046 AMBICA ENG. 46 SALUTION TANK ( HOMONISER) ST-500 TF-047 INDO GERMAN 47 SALUTION TANK ( HOMONISER) ST-500 TF-048 INDO GERMAN 48 SALUTION TANK ( HOMONISER) ST-500 TF-049 INDO GERMAN 49 SALUTION TANK ( HOMONISER) ST-200 TF-050 INDO GERMAN 50 PRESSURE VESEL PV-100 TF-051 INDO GERMAN 51 VIAL FILLING M/C 8 HEAD LACS-200 TF-052 LAXMI ENG. 52 VIAL SEALING M/C 8 HEAD LACS-200 TF-053 LAXMI ENG. 53 DHS. 12KW TF-054 OSHO TECHNO 54 VIAL WASHING M/C ( MANUAL) VWM-350 TF-055 KAILASH MACH. 55 VACCUME PUMP CV-500 TF-056 ACMEVAC 56 ELECTRIC CONTROL PANEL ECP-630 TF-057 SHIVAM IND. 57 AIR HANDLING UNIT ( TUNNEL) AHU-3500 TF-058 WAVES 58 AIR HANDLING UNIT ( TUNNEL) AHU-2000 TF-059 WAVES 59 AIR HANDLING UNIT ( TUNNEL) AHU-3500 TF-060 WAVES 60 AIR HANDLING UNIT ( TUNNEL) AHU-3000 TF-061 WAVES 61 AIR HANDLING UNIT ( TUNNEL) AHU-2000 TF-062 WAVES 62 AIR HANDLING UNIT ( TUNNEL) AHU-2352 TF-063 WAVES 63 AIR HANDLING UNIT ( TUNNEL) AHU-779 TF-064 WAVES 64 AIR HANDLING UNIT ( TUNNEL) AHU-882 TF-065 WAVES 65 STICKER LABELING M/C ASAL-250 TF-012 N.K. ENG. 66 TURN TABLE 32 INCH TF-013 LAXMI ENG. 67 AIR HANDLING UNIT ( TUNNEL) AHU-882 TF-066 WAVES 68 AIR HANDLING UNIT ( TUNNEL) AHU-2000 TF-067 WAVES 69 AIR HANDLING UNIT ( 2 & 10 ML) AHU-3500 TF-068 WAVES 70 AIR HANDLING UNIT ( 2 & 1 0 ML) AHU-574 TF-069 WAVES 71 AIR HANDLING ( 2 & 10ML) AHU-2000 TF-070 WAVES 72 AIR HANDLING UNIT ( 30ML) AHU-2000 TF-071 WAVES 73 AIR HANDLING UNIT ( 30ML) AHU-2000 TF-072 WAVES 74 AURO WATER PLANT AWP-1000 TF-073 PAUL WAT.
SASBIOSYNTH 38
TRET.
75 AURO WATER PLANT AWP-500 TF-074 PAUL WAT. TRET.
76 LAMMINAR AIR FLOW 4x4 TF-075 THERMADYNE 77 LAMMINAR AIR FLOW 10x3 TF-076 THERMADYNE 78 FLY KILLER 2 FIT 40W TF-077 PHILIPS 79 TURN TABLE TF-078 BHOLE ENG. 80 TURN TABLE TF-079 BHOLE ENG. 81 TURN TABLE TF-080 LAXMI ENG.
82 PASS BOX 2x2 TF-081 FOOD & PHARMA
83 PASS BOX 2x2 TF-082 FOOD & PHARMA
84 PASS BOX 2x2 TF-083 FOOD & PHARMA
85 FIRE EXICUTER (ABC) 2 Nos FE-05 TF-084 NATIONAL ENGG.
86 FIRE EXICUTER (ABC) 2 Nos FE-05 TF-085 NATIONAL ENGG.
87 AIR CARTAIN 3 FIT TF-086 88 AIR CARTAIN 2 FIT 40W TF-087
Anti-Cancer area
1 Vial filling mc. 6head Bhole -Techno 2 Rotary vial sealing mc. Single head Laxmi make 3 Semi-automatic single head Bhole Techno
sealing/ROPP machine 4 Stirring machine Sk Pharma 5 Pre-Filled syringe filling mc. Hare Krishna 6 Washing MC Jet type Laxmi make
5.2 DESCRIPTION OF PLANNED PRENTIVE MAINTENANCE PROGRAM AND
REPORTING SYSTEMS
SASBIOSYNTH 39
All the major equipments are kept in good working condition by the systems of
preventive maintenance. All the activities related to maintenance is kept properly and
recorded.
5.3 QUALIFICATION AND CALIBRATION INCLUDING RECORDING SYSTEMS, SYSTEM
VALIDATION PROTOCOL.
All the critical equipments are calibrated and records of the calibration are being
maintained. Written procedures are also available with the concern department.
6. SANITATION
6.1 CLEANING RECORDS OF THE AREA AND EQUIPMENT :
Written procedures are made and kept available for the cleaning and sanitation of the
manufacturing area and the equipments. The cleaning procedure is stringently followed
and relevant records are maintained. Eating, chewing, Drinking Alcohol and smoking is
strictly prohibited in the manufacturing area. The area is kept free from dust and waste.
7. DOCUMENTATION :
7.1 ARRANGEMENTS FOR PREPARATION, REVISION AND DISTRIBUTION OF
NECESSARY DOCUMENTS.
The manufacturing and analytical records are maintained to comply with the statutory
regulations. The MFR's, BMR's and BPR's are being issued by the authorized concern
person and have all the details of the manufacturing of the manufacturing of the product
along with the detail of precautions and preventive measures. Authorized personnel
handle the document only. The plant head and Quality Assurance head approves such
documents.
7.2 MICROBIAL CONTROL ON WATER AND AIR
Proper records are made for the same and are being signed by the Plant Head and the
Q.A. head and kept in record. all the records are checked on regular intervals during the
Internal Audit and signed by the head of the Organization. The records are made as per
the SOP designed for the same.
8. PRODUCTION
8.1 Process Flow
8.2 ARRANGEMENTS FOR HANDLING THE RAW AND PACKING MATERIAL
SAMPLING AND RELEASE OF THE PRODUCT.
SASBIOSYNTH 40
All the R.M. and P.M. are entered in the warehouse through proper entries with
particulars like ARN Nos., material description, manufacturer's name, and Vendor no.
mfg date, exp date etc. MRN is prepared and given to the QC Department for testing and
approving the said material. The material is kept in Quarantine till it is approved and the
label is not pasted on the bag.
8.2.1 Quality control department will sample the product as per the SOP with the
written procedure. After the material is checked the approval slip is sticked on the bags
of the material. The materials that are not as per the specification are labeled as
"RENECTED" and the kept aside. Only aproved material is issued for production as per
the FIFO system.
8.2.2 Materials are dispense as per the Batch Manufacturing Records by qualified
manufacturing chemist in presence of Q.C. persons with checks of the weights and
wrights and measures with proper AIR no. and approved label.
8.2.3 All the dispensed materials are kept in tight container with proper identification of
the material, quantity, AR No. and the purpose for which the material has been drawn.
8.2.4 At all the time when the material is handled, the personnel handling the material
should be in clean clothing, head cover and pollution mask. All the process should be in
clean and tidy area.
8.2.5 The products should be given for final packing only when the QA department
gives the line clearance as the SOP guidelines mentioned by the AQ team of the
Company. The approved packed product should be then sent to the Bonded Finished
Goods Room. 8.3 ARRANGEMENTS FOR HANDLING THE REJECTED MATERIAL:
In case of any Raw Material is being rejected by the QC department the container is
pasted with "Rejected" label by and transferred to the marked area for Rejected
Material.
8.3.1 On the receipt of rejected report, the warehouse department will immediately
inform the Commercial and Materials Department and necessary arrangements should
be made to return the material.
8.4 DISCRIPTION OF GENERAL POLICY OF PROCESS VALIDATION:
The first three batches of any new product validation are being carried out under the
supervision of the parent Company and the data is generated. For own products the data
is generated as per the guidance of the in huse QC and R & D team.
SASBIOSYNTH 41
9. QUALITY CONTROL DEPARTMENT:
9.1 DESCRIPTION OF THE QUALITY CONTROL AND ASSURANCE DEPARTMENT AND
THEIR SYSTEMS:
Responsibilities and procedures:
9.1.1GMP requirements: The Company's GMP policy adheres to international standards
set by WHO and aims at assuring that only those products that have met the established
specification and are packed and labeled under proper control ae distributed.
9.1.2 Pharmacopoeial requirements: Wherever available Pharmacopoeial standards
form the basis of specification for both raw material and finished goods.
9.1.3 Raw materials: ll raw materials received are physically inspected and assigned
lot/batch Nos and are quarantined till they are approved for use. Each material is
sampled according to standard sampling procedure and is sent to Analytical Lab for
testing. If acceptable, it is moves to the released storage area, properly labeled to
indicate the item no., name of the material, batch no, date of release and signature of
the Q.C. Inspector. Any material not meeting required standards is isolated, labeled as
'reject' and returned to the supplier or disposed off promptly. On site periodic inspections
are conducted to verify suppliers' compliance to specifications.
9.1.4 Containers : All containers and packing materials have detailed specifications
and test procedures.
9.1.5 In process Control : The main function of the in process quality assurance system
is to assure that all products have uniform purity and quality within a batch and batch –
to – batch.
9.1.6. Before start checking.
9.1.7 Environmental control and sanitation :
The following are reviewed and checked based on written procedure. Sanitation,
Cleaning Records, Ventilation System – Filters, Pressure gauges, humidity monitoring,
microbial monitoring and Water system.
9.1.8 Manufacturing working formula procedure.
These procedures are checked for each production batch before, during and after
product approval.
9.1.9 Raw materials: It is ensured that all the raw materials are taken to the Production
Dept. in clean containers.
9.1.10 Manufacturing equipments : It is the responsibility of the quality assurance that
all the manufacturing equipments are thoroughly cleaned before use, that proper
SASBIOSYNTH 42
equipment and tooling is being for each Product that each equipment in use is identified
by proper batch details.
9.1.11 Before start checking : Only released, properly labeled raw materials are allowed
in the manufacturing area. Quality assurance checks if temperature and humidity in the
area are within the specified limits. The manufacturing procedure is checked at every
stage and equipments are verified and documented. Samples for analysis are taken to
the analytical lab at specified stages and intervals.
9.1.12 Finished Products : Each lot of finished products is tested to ensure its
compliance with specified standards. The bulk product is released to packing only after
this compliance is ensured. Samples of packed product are also sent to Analytical lab for
final testing if required.
9.1.13 Release for Distribution / Sales : This release takes place only after Quality
Assurance evaluates the batch records of all in process tests and controls and all tests
of the final product to determine whether they confirm to specifications:
9.1.14 Control Function :
The Control function looks after the approval of Raw Materials,
In process samples and finished product materials.
9.1.15 Technical Function:
QA's Chief Technical support activities include.
a) eGMP / cGLP Training
b) Review and approval of Specifications.
c) Documentation Controls (SOPs) and
d) Support to process / product validation.
e) Equipment validation
f) Area Validation
g) Internal audits / External Audits.
Compliance Function:
This relates to Quality Assurance Controls that are exercised on Vendor Control, Product
release etc.
SASBIOSYNTH 43
10. CONTRACT MANUFACTURING AND ANALYSIS
The representatives of the big MNCs visit the company's premises and audit the facility for
GMP compliance. They also offer suggestions for improvement of the facility.
11. DISTRIBUTION COMPLAINTS AND PRODUCT RECALL:
ARRANGEMENTS AND RECORDING SYSTEM FOR DISTRIBUTION
All the packed finished goods are transferred to the warehouse where they are stored. Batch
wise stock records are maintained. On written requisition from Marketing personnel / Loan
license, warehouse personnel and sent to various customers through Marketing
Department. Warehouse department maintains appropriate records.
11.1 ARRANGEMENTS FOR THE HANDLING OF COMPLAINTS AND PRODUCT RECALL.
SAS BIOSYNTH policy is to see that all products supplied by them should meet the required
mandatory specifications. However, when there is a complaint on quality / quantity from the
customer, the complaint is thoroughly investigated and wherever necessary, the product is
called back by marketing Department in consultation with the Quality Assurance manager is
fully invested with all powers to look in to the matter pertaining under this head.
11.2 All formalities completed after receiving the returned material. The packages are
physically verified for quantities and intimation is sent to Q.A. for retesting.
12. SELF INSPECTION:
SELF INSPECTION SYSTEM (Internal audit)
We inspect & audit on quarterly basis with written checklist system for all areas where the
self inspection to be conducted by a cross functional team are as follows.
a) Stores
b) Production
c) Quality control dept.
d) Quality Assurance dept.
e) Purchase Dept.
f) HRD
SASBIOSYNTH 44
All the raw materials are identified with code Nos. and in-house Q.A. Nos., which can be
crosschecked with QC, stores or batch sheets. Similarly packing materials can be traced
through batch sheets.
PROCESS CONTROL HAS SELF INSPECTION SYSTEM:
The batch sheets are provided with relevant data from QA, stores, etc. namely in process
reports, analytical reports, batch formula, in house batch No. etc. Restricted areas such as
Pharma area for potent drugs will have separate identity for people working there to prevent
entry of unauthorised persons.
13. STABILITY STUDIES:
Real time & Accelerated stability studies are conducted for the products by QC department.
14. OUR VISION
To emerge as a Global player by developing a team of competent persons.
Ø To enter the advanced markets of the world with a sustained presence over the long
term.
Ø To serve the ailing human beings with quality medicines at affordable prices by
continuous upgrading system, technology, knowledge for excellent productivity & quality.
Ø To cater to leading Pharma companies for Contract manufacturing / Job work
manufacturing & to grow as partners of multinational companies.
Ø To make operations safe and reliable by minimizing waste, implementing effective waste
treatment and protecting the environment.
15. QUALITY OPERATIONS AT SAS BIOSYNTH
We consider QUALITY as:
A process or mechanism, which generates.
Ø Consistency
SASBIOSYNTH 45
Ø Reporducibility
Ø Accuracy
Ø Integrity, and
Ø Precision
with
Ø Better understanding
Ø The aid of sound scientific information
SASBIOSYNTH 46
QUALITY OPERATIONS AT SAS BIOSYNTH
Our Objective
Our best talented team believes that, it is important not to produce pharmaceutical
products of the highest quality but also demonstrate them to be so. While committing to an
on-going improvement in performance revolving around effective customer management,
we maintain:
The highest levels of integrity in business conduct and strong sense of public responsibility.
Responsibility for Quality
We at SAS BIOSYNTH are obsessed with "making the best" Quality. It is significant to
everything and everyone in our organization because we care for life and that precisely is why
our motto reads "Economical Quality Formulations with SAS BIOSYNTH, Our way to serve
Humanity."
List of Laboratory Equipments
SR. NO. MACHINE/EQUIPMENT DESCRIPTION 1 HPLC UV/VIS DETECTOR (SPD -10-A) 2 HPLC PUMP (LC-10 80) 3 HPLC INJECTOR (20 MICRO LITRE) 4 DELTA SOFTWARE (DELTA 5.0) 5 UV-VISIBLE SPECTROPHOTOMETER 6 BROOKEFIELD VISCOMETER (LVT) 7 ELECTRONIC ANALYTICAL BALANCE 8 FLAME PHOTOMETER CI -22 D 9 PHOTO FLUOROMETER-151 10 DISSOLUTION APPARATUS 11 KARL FISCHER TITRATER 12 HUMIDITY CONTROL OVEN 13 COLONY COUNTER 14 DISINTEGRATION TEST APPARATUS 15 FUMIGATOR 16 FRIABILITY APPARATUS 17 HOT AIR OVEN 18 HOT PLATE 19 HEATING MANTLE 20 IR MOISTURE BALANCE 21 INCUBATOR B.O.D. 22 LAMINAR AIR FLOW 23 LEAK TEST APPARATUS
SASBIOSYNTH 47
24 MAGNETIC STIRRER 25 MUFFLE FURNACE 26 MELTING POINT APPARATUS 27 POLARIMETER 28 pH METER 29 REFERIGERATOR 30 UV VIEWING CABINET 31 VACCUM PUMP (Oil Free) 32 VERNIER CALIPER 33 WATER BATH 34 ZONE READER 35 THICKNESS TESTER 36 HARDNESS TESTER 37 AUTOCLAVE 38 ANALYTICAL BALANCE 39 BULK DENSITY APPRATUS 40 CENTRIFUGE MACHINE
16. INSTALLED CAPACITY
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Per day
1. Beta lactam
a)Dry powder injections 200,000
b)Capsules 400,000
c)Dry Syrups 100,000
1. Non Beta Lactam
a) Liquid Injections 300,000
b) Dry Powder Injections 200,000
c) Hormone Injections 100,000
d) Anticancer Injections 50,000
2. EYE/EAR DROPS 100,000
4. LIQUID SYRUP 200,000 5. OINTMENT 200,000 6. POWDER SACHET 100,000 7. LIQUID SACHET 100,000
SAS BIOSYNTH
Baddi – 173205 ,Distt. Solan, (H.P.)
RAJARHAT, NEW TOWN, KOLKATA
