GENERAL INFORMATION...Dr. AHMED ALI Dr. HAMDAN AL RAWI 1. GENERAL INFORMATION 1.1 Brief Description: Middle East Laboratories Co. Ltd. (MELCO) is an Iraqi company for pharmaceutical

MIDDLE EAST LBORATORIES CO. LTD. SITE MASTER FILE

BAGHDAD -IRAQ

1 | P a g e EFFECTIVE DATE 1/3/2013 REVISION NO. / 1

PREPARED BY REVIEWED BY APPROVED BY

CHEMIST HASAN FADHIL

Dr. AHMED ALI Dr. HAMDAN AL RAWI

1. GENERAL INFORMATION

1.1 Brief Description:

Middle East Laboratories Co. Ltd. (MELCO) is an Iraqi company for

pharmaceutical drug industry. It was founded in Baghdad in 1989.

1.2 Activity and License:

MELCO have a valid Manufacturing License (No.3787), issued Iraqi

Ministry of Health for the manufacture of the following

pharmaceutical dosage forms:

- Tablets

- Hard capsules

- Oral solutions

- Topical solution

1.3 Outside Activity:

All products of MELCO are manufactured inside the company.

1.4 Important Information:

- Name of the company: MIDDLE EAST LABORATORIES CO. LTD.

- Address: Iraq – Baghdad –Ewadiah

- Phone: 07901911451, 07901911491

- E-mail : [email protected], [email protected]

mailto:[email protected]

mailto:[email protected]


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1.5 Types of Products:

- anti- inflammatory

- anti- histamine

- anti-septic

- expectorant

- non-steroidal anti- inflammatory

- antispasmodic

- anti- bacterial

- bronchodilator

1.6 Accommodation:

- Size: 2,114 square meter (45 X 46.6) meters

- 1st floor: management office, liquid department (syrup, suspension

and topical solution).

- 2nd floor: Q.C department, tablet and capsule department and gargle

department.

The factory has built up area 2,700 sq. meter. The connected power

capacity is 200 Kv and 350 Kv. The storage area is well maintained

and has air conditioning facilities to store drugs /products in a cool

place. RO Plant has capacity to produce 600 and 1200 lt. per hour for

Purified water on a continuous basis. The whole facility is well

maintained at all times with adequate and prompt repairs and paintings

and servicing.


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1.7 Number of Employees And Workers:

Pharmacists 3

Chemist 3

Biologist 1

Chemical Engineer 1

Mechanical Engineer 1

Business management 1

Technician 2

Workers 50

Distributor 1

Pursuer 1

1.8 Outside Relations

MELCO sometimes take assistance of outside analytical laboratories

for sophisticated test from (Ibn Senna Institution for Drug Research).

1.9 Quality Management:

1.9.1 Quality Policy

Middle East Laboratories Co. Ltd. has been established in accordance

with the Companies Law No. (36) for the year (1983) according to the

provisions of Article (21) of the Act above and subject to the

instructions of the Ministry of Health in Iraq and the Ministry of

Industry and Minerals in Iraq, which is always seeking since its

inception to manufacture medicines high quality and conformity to

specifications according to the constitutions of internationally


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approved medications in order to compete with pharmaceutical

products traded in the domestic and overseas markets and gain

customer satisfaction so as to enhance its position in the

pharmaceutical industry and are subject to the laws and regulations for

safety and environment while ensuring the safety of employees in the

company.

The senior management and all associate in the company works as a

team to ensure the appliance of the international standard operation

(ISO 9001:2008) and maintain the quality of the product through the

events of quality assurance and continuous improvement, in

accordance to the latest developments in the field the pharmaceutical

industry in the world to serve the increased production and lower

costs.

1.9.2 Description

The employees in the Division of Quality Management (Records,

Audit, measurement, analysis and improvement at the beginning of

each year start to develop an annual program that includes the

following:

• Planning monitoring and measuring processes: the company should

implement appropriate modalities to measure and control processes

system quality management and that these methods must explain the


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ability of these operations to reach the planned results. These

operations include:

- Sales, service and customer complaints

- Performance with regard to quality management system relating to the

product

• Self-Inspection Planning: (describe in details in section -9)

• Planning documentation processes: which includes, Application Form

(issue - edit - delete)

• Planning improvement: Are done through the activation of a

management review and action planning targets quality where senior

management review of quality management system in the time periods

planned to ensure the continued relevance and effectiveness, and by

reviewing the audit results.


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2. PERSONNEL

2.1 Organization Diagram


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2.2 Qualification

Name Qualification Occupation Experience

Mr. Hamdan Al Rawi B.Sc. PHARMA Managing director 46 Years

Mr. Ahmed Ali Ibrahim B.Sc. PHARMA Vice managing

director

46 Years

Mr. Sami Hamed B.Sc. PHARMA Registration

director

31 Years

Mr. Hasan Fadhil M.Sc. CHEMISTRY Q.A manager 8 Years

Mr. Saed Asaad M.Sc. CHEMISTRY Production

manager

5 Years

Mr. Saif Mohamad B.Sc. CHEMISTRY Production officer 5 Years

Ms. Marwa abed-Hussien B.Sc. E.CHEMISTRY Q.C manager 8 Years

Ms. Huda Abid-amir B.Sc. Biology Q.C officer 2 Years

Ms. Hawraa mohamed Business management

institution

Storage manager 3 Years

Mr. Zaid jalel Mechanical Engineer Maintain manager 7 Years


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2.3 Health Requirements

All persons engaged in production should be free from

infections and communicable diseases. In order to conform to

the above requirement, the following precautions are taken:

- Medical examination of all employees is done at periodic

intervals and not less than once annually, by a qualified Medical

Practitioner

- In addition to the above precautions, supervisors are always

required to keep watch for any signs of disease or weakness in

workers.

2.4 Personnel Hygiene Requirements

All employee that enter the manufacturing area should wear

protective clothing appropriate to the operation to be performed

where the working conditions imposed wear clothes (headscarf /

muzzle / gloves / robe industrial work the fewest number of pockets /

cover shoes / and goggles for the eyes).

Any employee has flu symptoms or cold or who have open wounds

not allowed to operate within production and must conduct medical

examinations periodically.

Eating or drinking, chewing gum and smoking are not allowed in

production areas and warehouse.


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3. PREMISES

3.1 Manufacturing Area

3.1.1 Tablet Manufacturing Diagram


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3.1.2 Liquid Manufacturing Area


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3.2 Nature of Construction

The manufacturing premise has RCC (reinforced concrete cement)

constructed with the following features in mind:

1. To prevent entry of insects and rodents.

2. With smooth interior surfaces free of cracks and crevices-in order to

allow easy cleaning and disinfection.

3. Adequate lighting facilities.

3.3 Ventilation System

The company maintains pressure differences among production

rooms in the same class as well as between different classes to

prevent cross contamination. The procedure is as follows:

A more negative pressure is applied into a dusty room than it is in the

corridor. A more positive pressure is applied to a less dusty room than

it is in the corridor.


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3.4 Water System

Potable water is transferred in to RO Plant for water purification

before pumped into RO Plant. The water in RO Machine is

transferred through sand filter and carbon filter to lessen dissolved

CO2, dissolved solids in water that could influence purified water

conductivity. The water is then pumped using High Pressure Pump

onto RO membrane. Purified water is distributed by sanitary pump

with minimal flow velocity of 1.5 m/s into the compounding tanks.

There is two RO plant one of 600 lit / hour and the other with 1200 lit

/ hour. An activated log book is held to record the pH, conductivity of

the purified water twice per a day.

4. EQUIPMENT 4.1 List of Equipment

(A) Weighing Room

S. Equipment Name Capacity

1 Weigh Balance 200 Kg

2 Weigh Balance 60 Kg

3 Weighing booth ----


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(B) Tablet Department

S. Equipment Name Capacity Quantity

1 Sifter 30 Kg 1

2 Rapid Mixer Granulator 60 Kg 1

3 Rapid Mixer Granulator 20 Kg 1

4 Trolley of FBD 60 Kg 2

5 Fluid Bed Dryer 60 Kg 1

6 Double Cone Mixer 800 L 1

7 Double Cone Mixer 280 L 1

8 Compression Machine 35 punches 1

9 Compression Machine 29 punches 1

10 Capsule filling machine 45,000 / hr. 1

11 Capsule De-Duster --- 1

12 Tablets De-Duster --- 1

13 Dust Collector --- 2

14 Coating Pan 60 Kg 1

15 Hot Air Blower --- 1

16 Spry Gun 1 liter 2

17 Exhaust --- 5

18 Blister Machine 100,000 / hr. 1

19 Blister machine 200,000/hr. 1

20 Water Cooler 100 liter 1

21 Compressor --- 2

22 De-blister machine --- 1

23 Colloidal Mill


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(C) Laboratory

S. Equipment Name Make Quantity

1 UV-VIS spectrophotometer Sunny 1

2 UV-VIS spectrophotometer Shimadzu 1

3 Digital pH meter WTW 2

4 Conductivity meter WTW 1

5 Friability tester Electrolab 1

6 Disintegration tester Electrolab 1

7 Tablet dissolution tester Electrolab 1

8 Bulk density tester Electrolab 1

9 Hardness tester Copley 1

10 Ultrasonic KLARY 1

11 Distillation system --- 1

12 Centrifugal 80-2 CE 1

13 Single pan balance / electronic Mettler 1

14 Single pan balance / electronic sartorus 1

15 Hot plate with magnetic stirrer BIBBY 1

16 Autoclave --- 1

17 Laminar flow LABTECH 1

18 Microscope Bausch & Lomb 1

19 High performance liquid chromatography Shimadzu 1

20 High performance liquid chromatography Knauer 1

21 Fourier Transform Infrared (F.T.I.R) Thermo 1

22 Vernier Mitutoyo 2

23 Water bath Gallenkamp 1

24 Oven WH-43 2

25 Refrigerator Ishtar 1

26 Desktop computer Dell 1

27 Laptop computer Acer 1

28 Incubator DH4000B 1

29 Incubator Al-Salih 1

30 Stability Chamber Osworld 4


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(D) Syrup Department

S. Equipment Name Capacity

1 Compounding tank with stirrer and homogenizer 2000 liter X1

2 Compounding tank with stirrer and homogenizer 1000 liter X 4

3 Compounding tank with stirrer and homogenizer 600 liter X 2

5 Compounding tank with stirrer and homogenizer 500 liter X1

6 Compounding tank with stirrer and homogenizer 240 liter

7 Filling tank with stirrer 1000 liter X 3

8 Filling tank with stirrer 700 liter

9 Filling tank with stirrer 2000 liter X1

10 Colloid mill 300 liter / hour

11 Labeling machine 3000 bottles / hour X 3

12 Labeling machine 7000 bottles / hour X 2

13 1- nozzle filling machine / semi sealing machine bottles / hour

14 6- nozzle filling machine / Sealing machine 2500 bottles / hour X 3

15 7- nozzle filling machine / semi-sealing machine 1000 bottles / hour

16 8- nozzle filling machine / sealing machine 10000 bottles / hour

17 Cartooning machine 4000 bottles/ hour

18 Rotary bottle washing machine 5000 bottle / hour

19 Packet printing machine 3000 packet / hour X2

20 Leaflet machine 10000 leaflet / hour

21 Press filter 50 liter X2

22 Shrink machine / manual ---

4.2 Preventive Maintenance

Administrator and maintenance during the execution of daily work

and when there is a need to withdraw a protective reaction form and

fill out this form of agreement with the quality control department

officials so as to include a preventive determine the type and time of

implementation in accordance with the form above. As well as

requests are raising preventive actions to direct manager for approval.


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4.3 Sanitation

Cleaning and Sanitation activities are implemented according to

Sanitation SOP. They are grouped into cleaning and sanitation of

(machine, room, processing tool). Sanitation material used, cleaning

agent, disinfectant, cleaning agent, disinfectant are changing

frequency. Outside of building is also daily cleaned. The walls, roof,

gates and doors of building are periodically maintained and cleaned.

Detail of working steps is recorded in SOP for routine sanitation

implementation, and every sanitation personnel should follow the

SOP.

5. DOCUMENTATION

5.1 The documents are prepared and formulated clearly and accurately by

company officials who implement and oversee production operations,

maintenance and quality control and the Administration Department

and Quality Management to match the steps contained in the standard:

ISO 9001:2008.

5.2 Control quality management system documentation includes:

- Upon receipt of the documents that have been reviewed and approved

by the managing director of the company and a representative of the

administration official documents is stamped with a blue color seal at

the back of each document and is considered an original document and

stored in the Documentation Division.


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- The official of documents filmed the copies needed for distribution by

the required number in the list of controlled documents and controls

the seal of the face of each page with green stamped color and is

considered a controlled document.

5.3 Request (issue - edit - delete) and new documents, which includes:

- Shows the request for quality management department for the purpose

of audit and express an opinion and then presented to the

representative of the administration to take the appropriate decision.

- The official of documents withdraws the old copies from the places of

use and distribute the new issue instead of the modified documents

and damaged the old copies and keep one copy (original copy) of the

canceled documents in a special file (Canceled Documents File) and

stamped the face of the front page with the seal of red color and is

considered a canceled document.

5.4 The master batch record contains:

- Dispensing raw material form

- Processing batch record

- Certificate of chemical analysis issued by Q.C department

- Certificate of biological analysis issued by Q.C department

- SOP of cleaning the compounding room

- In-process control


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6. PRODUCTION

6.1 Description Of Production Plan

Every process flow has process-points that describe process detail,

(SOP). It also has inspection-points that explain inspection detail and

inspection implementation by person in charge. The process flow is

divided into several steps, such as material receiving step, dispensing

the raw materials, compounding process, filling, sealing, labeling,

packing and finished product delivery step. Every step will go

through inspection process according to acceptance criteria

determined by QC Department.

The flow chart of production for tablet and syrup department is shown

in section (3.1.1 and 3.1.2) respectively.

6.2 Handling Of Raw Materials

Upon receipt of the raw materials/packing materials, the material is

unloaded on the receiving bay. The correctness of the material

received is checked with the delivery note. Supplier’s batch number

and the quantities are cross verified.

Sampled containers are labeled with a yellowish orange “UNDER

TEST LABEL”, the label indicates name of the material, batch

number of the supplier, analytical report number, and date of

manufacturing, date of expiry If the sample complies with the

approved specifications, “An APPROVED LABEL” in green is

pasted and if it does not meet the specifications, a red “REJECTED”

label is pasted on the containers.


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6.3 Production Process

SOP is followed for all manufacturing and packing operations.

Identity of materials at processing stage is confirmed by reading

dispensing labels. Weights are counter checked. The dispensed raw

materials are processed as per the instructions defined in the product

specific batch manufacturing record. Processing activity is

implemented according to process stage flow of each type of product

and master batch record documentation.

6.4 In-Process Inspection

In-process control/ tests are carried out as per the frequency and

procedure defined in product specific batch records. In-process

checks are conducted by Production and the Quality assurance,

independently at defined intervals. QC department is responsible for

testing and releasing implementation in production process.

6.5 Finish Product

Intermediate products are analyzed and approved by the Quality

control prior to the packing operation. The goods are released for

dispatch after the completion of the finished product analysis and the

review of the batch documents and the analytical reports by Quality

assurance. Products released by Quality Assurance are transferred to

the approved finished product storage area.


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6.6 Handling The Rejected Materials And Products

Rejected product or material is identified clearly and place in separate

location to prevent unwanted/ accidental usage.

- If raw material is not conforming to the specifications, it is labeled

“REJECTED” and is isolated and it is sent back to the vendor.

- If printed packing material is rejected, it is isolated and destroyed at

the site in the presence authorized persons.

- If any intermediate or finished product is found to be non-conforming,

it is isolated and marked with the appropriate label. It is then referred

to the Manager Quality Assurance, who investigates the problem.

6.7 General Policy For Validation Process

6.7.1 The Prospective Validation: Prospective validation

conducted for 3 continuous batches where the validation result comply

all specification of (In house, USP and BP).

6.7.2 Revalidation Policy:

- One batch of each product every year.

- Qualified equipment undergoes major modification, replacement of

critical spares that shall affect equipment performance.

- Location of equipment is changed.

- Change of cleaning agent/ method.

- Process/ Formula Change.

- Change of any critical equipment in the chain of equipment used for

product Manufacturing.

- Change in analytical method.


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7. QUALITY CONTROL

Quality control department have experienced, competent and

technically qualified personnel to take on various activities of the

department.

Quality control is responsible for sampling and analysis as per

approved specifications. Release/reject authority for all raw materials,

packing materials, intermediate products and finished products lies with

quality control only, but final release authority for product lies with Quality

assurance.

The laboratory has been designed and equipped with facilities for

chemical, microbiological analysis. Microbiological area is provided with

laminar airflow and other facilities to carry out limit tests, assays, water

testing and environment monitoring.

All volumetric solutions used in assays and other tests are prepared

from material of a suitable grade in accordance with the approved

procedures. Containers holding volumetric solutions are labeled with details

like name of the solution, strength of solution, date of preparation, and the

initials of the person who prepared the solution.


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8. DISTRIBUTION, CUSTOMER COMPLAINTS AND RECALL

8.1 Distribution

Distribution in the Middle East includes two types:

1 - Private sector: where direct contact with customers is held and

their requests are recorded and sent to stores.

2 - Kimadia: The distribution form in contract terms to be agreed on

quantities, prices and delivery schedule. The products are shipped by

refrigerated vehicles.

8.2 customer complaints and recall system

As soon as the product/batch to be recalled is/are identified, licensee

or representative of licensee or QA in charge shall review the

information related to the defective product/batch and decide about

recall as per the procedure established.


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9. SELF-INSPECTION SYSTEM

9.1 The self-inspection incorporate productivity has three forms:

9.1.1 Checking the quality of the system: is a valuation of the quality

management system adopted in the company.

9.1.2 Checking the quality of operations: a valuation of the quality of

operations directly related to manufacturing.

9.1.3 Checking the quality of the products: a valuation of the quality

of finished products in order to access to information showing

the extent of compliance with the required specifications and

suitability for use

9.2 The self-inspection activities:

The director of quality management to develop a plan to audit includes

all activities necessary, status checklist for internal audit quality. Where

the action form of corrective or preventive is initialized and handed over

to the auditors so that these models are filled for each case that need to

act preventive or corrective.

Checker in the final stage displays the results of the audit and informed

and agreed on the applications of most effective corrective or preventive

and provided a copy of the requested corrective actions or preventive to

the auditor upon by the director of quality management and saved the

originals with Director of Quality to follow implementation of agreed

actions.


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10. List Of Products

S. Brand Name Generic Name and Strength

1 Actimel Syrup Triprolidine HCl

Pseudoephedrine HCl

2 Antusin Syrup Dextromethorphane HBr

Chloropheneramine maleate

3 Cyprodine Syrup Cyprohepatadine HCl

4 Ketofen Syrup Ketotifen (as hudrogen Fumarate)

5 Poramine Syrup Chloropheneramine maleate

Menthol

6 Ventomel Syrup Salbutamol

7 Quibrophylline Syrup Anhydrous theophylline

Guiaphenesin

8 Dexamethasone Elixir Dexamethasone

9 Flagimel Suspension Metronidazole benzoate

10 Ponstamel Suspension Mefenamic acid

11 Brufemel Suspension Ibuprofen

12 Povidon Iodine solution

10%

Povidone iodine 10 % w/v

13 Povidon Iodine solution

7.5%

Povidon Iodine 7.5 % w/v


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14 S.S.Lotion Selenium sulfide

15 Duspatamel 135 Tablet Mebeverine HCl

16 Sulfatrime Tablet Sulfamethaxazole 400mg

Trimethoprim 80 mg

17 Enalapril 5 Tablet Enalapril maleate 5 mg



20 Flagimel 250 Tablet Metronidazole 200 mg

21 Flagimel 500 Tablet Metronidazole 500 mg

22 Cyprodine Tablet Cyproheptadine HCl 2 mg

23 Tenoximel Capsule Tenoxicam 20 mg

24 Fungistat solution 1% Clotrimazole 1%

25 Erythroderm topical

solution 2%

Erythromycin 2%