7.0.IntroductionSTEPS IN TOTAL PMD PROGRAMME Guidelines for desingning and Implementing Programme▪Definitinon of Documents▪Objective of Documentation▪Importance of documentation▪Preparation Issue and use of documentation▪Product Traceability▪Storage and retention of documents and records▪Storage ,Retrieval of documents▪Disposal of documents .

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7.1.SPECIFICATION

Specification of active and inactive starting material

Specification of Packaging material

Specification for intermediate and bulk products

Specification for finished products

Documents Required :API and Inactive starting Material Packing Material ,Intermeiate and bulk products,Finished products

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7.2. Master production and control record (MPCR)

7.3 Batch production and control records (BPCR)

7.4 Importsnt SOPs and Records

7.5 Change control

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7.6.Site Master Files ▪ General information ▪ Personnel▪ Premises and Equipments ▪ Documentation ▪ Production ▪ Quality control▪ Contract Manufacturinf and analysis Any Other

Services ▪ Post Operational Activities ▪ Self inspection▪ Export of drugs

Documentation Required Site Master Files

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7.0.Introduction :

Consider To Design PMD following Environmental Factors :

Manufacturing Activities Present and Planned :Tablets,Capsules,Injection,Liquid Orals and Ointments

Countries Planned for Export:To decide requirements as per WHO,UK,Australia,South Africa

Computerisation Level in the company

Any other Consideration www.bp

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Steps in total PMD Progamme Step 1.0:

Select one Person from production and another from QC/QA ,whos knows about Organisation.

Step.2.0:

List out name and formulation departments

Step 3.0:

List out QC/QA Activities

Stp.4.0.

List out countries Planned for expertswww.bpha

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Step5.0:List out types of documents needed for experting countries.

First:Documents Required for

a.Personnel Training b.QC c.Bulding and factory d.Equipments e.Material and stores f.Engineering g.Marketing and distrubution h.Market Complaints

Second : For above categories decide following documents a.SOP b.Reports c.charts d.formats e.specification f.Test methods g.MPCR And BPCR

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Steps:06 Design documents

Format

Content

Size and Quality of papers

Step 7:

Explain and Train Concerned people

Step 08:Take trial run rehearsal and remove diffuculities ,redesign

Step.9.Implements the records

Steps 10.feedback and review of regular interval www.bp

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01.Definition of documents :Any written statement

02.Objective of Documentation:

2.1.Define system of information and control :

2.2.To follow correct procedure

2.4.To provide confirmation of task

2.5.To allow checking and calculation

2.6. to allow tracing of batch historywww.bp

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03.Importance of Documentation

3.1. It is a part if QA And should be related to cGMP

3.2.its defines specification and methods of manufacturing and control

3.3.it Ensures manufacturing personnels that what to do ? when to do? Where to do?why to do ?

3.4.ensure that the authorised person get all introduction ,it help him to release of batch

3.5.Helps in Audit :trail to invetstigate the batch history.

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4.1.Easy to use to check ,relevent data only.The documents which is not to be used should be removed.

4.2 The Documents should contain❖ 1.Company’s Name❖ 2.Purpose ,title of documents❖ 3.identity numbers❖ 4.Date of authorisation❖ 5.Date of expiry or reviews (in case of SOP)❖ 6.Signature of person prepare,Signature of person authorised thedocuments❖ 7.distribution list❖ 8.page number❖ 9.The way the documents is t be used and by whome❖ 10.The reason for revision to br documented❖ 11. Reference use to prepare the documents

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4.3.should be computerd printed, the batch documents should be initiated to confirm that it is verified .

4.4.correct the documents,initial,sign,and date the uncorrected statement should be readable;where possible reason for correction is to be mentioned

4.5 Documents which have provision for entry should have

-space for entry -some space between two entries

- Information entered should be readable

4.6.Instruction should be indirecct command 4.7.use up to date anfd authorised documents

,file supercoded documents.

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4.8.The responsible person of QA or person who is delegate should authorised

Master prodution and control record (MPCR)

Bactch production and control record (BPCR)

Standard operting procedure (SOP)

Master documents aaffecting quantity.

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5.0.PRODUCT TRACEABILITY

5.1 complete batch history should be available i.e when the batch/activities started and when completed and when disposal /distruction was done

5.2.Sales and retention of documents and records

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6.0.Storage and retention of documents and records

6.1.Upto one year after expiry ,where expiry date is nit applicable up to six years ,batch documenst aaaaaare retained.

6.2.Photocopy ,soft copy ,hard copy back up data are preserved safely.

Protect them from that loss alteration etc.

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7.1 Retrivel should be eay total list should be available showing :

The name of documents

Location of availability

Person to be contacted for retrieval

7.2.Batch production and control record (BPCR) is kept in key lock with QA

7.3Master Production and control record (MPCR) and master documents can be retrived permission of QA.

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0.8 Disposal of documents :

8.1 QA destroyes expired documents by shreding ,burning after proper documents and authorisation.

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It is the set of parameters the itoms is supposed to meet.we need specification for the following .

1.Active and inactive starting material

2.Packing material :primary,printe and others

3.Intermediate and bulk Product

4.Finished Pharmacutical product

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Common Contents in Any documents:

1.Name of the company

2.File of document ,specification

3.Dcocument number:Unique Identification number

4.Date of preparation ,Issue,Effective Checking,Authorisation And Issue

5.Name of person Prepared,Checked and Authorised .

6.circulation and distribution List:www.bp

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3.Specification for intermediate and bulk products

If these are purchased or sold ,the specification will be like starting Material.

If data are used to evaluate finished product ,specification becomes more useful.

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4.Specification For Finished Products Beside commmon poinsts more aditional

points will be as under. 1.Name of the product 2.Code no reference 3.List of active ingrediants 4.The formula or reference formula 5.limit for qualitativr and quantitive

requirements 6.Sampling Instruction 7.Limit for quantitative and qualitative

requirements 8.Testing Ref/Procedure. 9.Storage condition 10.Shelf life.

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Document required

Specification for:

Active and inactive starting material

Packaging materials

Intermediated and bulk drug

Finished product

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7.2Master Production and Control Record (MPCR)

Master production and control recod (MPCR)

Master formula record (MFR)

Master formula and packaging instruction WHO.

Master manufacturing and master packaging MCC(south africa)

Manufacturing formula and processing instructions.(TGA Australia).

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SOP for MPCR:

Should be available .

Purpose:

Uniformity from batch to batch.

Product and Batch size:

Prepare for each product and each batch size.

Prepared,Checked and Authorised:

The name person, designation and date who prepared,checked and authorised .

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CONTENTS IN MPCR:1.Name and stregth of product :

Paracetamol tablet I.P. 500mg

2.Lable claim :

a.Each tablet contains :

a.paracetamol I.P. 500mg

b.Each 5ml contains :

Paracetamol I.P. 125mg

Colour: amaranth.

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Sr.no Ingredients

specification

Overage Weight for tab

Weight for batch at 1.0 lakh

Tab

1 Paracetamol

IP 1% 505 50.0

2 Nitrocrystaline

cellulose

IP - 10 1.0

3 Starch IP - 25 2.5

4 Talc IP - 5 0.50

5 Magnesium stereate

IP - 5 0.5

6 Total 550 50.500

Remark:Paracetamol with bulk density not less than 0.8gm/cc is to be used.Microcrystalline cellulose:sieve size 325

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4.Theroretical yield:(Minimum and Maximum)

Granulation 100% (Qty.Kg)

Compression 100% (Qty.Kg)

Strip packing 100% (Qty.Nos)

Cartoning 100% (Qty.Nos)

5.Actual yield(Minimum and maximum)

Granulation 96-104%

Compression 94-106%

Strip packing 96-104%

Cartoning 98-102%

If the actual yield is not in the above limits investigation is required,explination is to be given and authorisation is needed.

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Sr.No Size Qty for Tab(Nos)

Wastage

1 Label (60 *100mm)

100 5

2 Tin container(dia

150mm*height:180mm)

100 1

3 Shipper box(L:500*w

300 *ht 200mm)

10 -

4 .Box label (60*100mm)

10 1

•Printed packing material is approved by QA with signature and data•All packing material is approved by QA

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7.Manufacturing and control instructions:

Give stage wise manufacturing instructions ,in process control limits,precautions,testing & sampling instruction.

To avoid multiplication,the reference of various SOP's used.

8.Location &Equipment:

Is described

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9.Equipment claiming,assembling,operation,calibration :

Reference of various SOP is made

10.Process control sampling instructions: with acceptable limit

11.storage conditions :At various stage.

12.Batch production and control Record(BPCR)www.bp

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Batch production & control record (US-FDA)

Batch record(Manufacturing) & batch record (packaging) (MCC-AFRICA)

It is replica of M.P.C.RBatch histroy :can be traced

content: (1) Production order: (a) Ingredients (Requirements): Is mentioned

with weight, specification &AR NO. for each Tab or unit & batch size

(2) Packaging Material requirement : is mentioned with size,quantity etc.

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(3) Process Record : Date,timing of activites

(i)Blending

(ii) Granulation

(iii) Drying

(iv) Compression

(v) Coating

4) Identification of location : room is mentioned

5) Identification of Equipment: on which process is done

6) Identification of person performed & supervised : name of person does the operation & supervises.

7)Actual yield : if not within limit,statement is given of actual yield is abnormal , investigate ,correct the mistake

8) Identification of packaging material:deatail of pack material size etc.

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9) Identification of ingredient :it is shown in ingredient reqirement

10) Line clearance

11) Process control

12) Specimen label :Approved by QA

13) Record of deviation : Investigation remark

14) Sampling : Details with person, time stage.

15) Result of examination : at various stages documents required

16) Batch production & control record for each batch produced

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1. Site master file

2. validation master plan

3. calibration master plan

4.Planned preventive maintance programme, product complaint handling SOP/R

4.Product recall & return: SOP/R

5.Distribution: SOP/R

6.Equipment: validation, operation , calibration,cleaning-log book

7.Equipment :assembley validation SOP/R

8.SOP/R

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9. Equipment and instruments: operation, maintenance calibration SOP/R.

10. Facility :cleaning, sanitation, maintenance SOP/R

11.Environment monitoring SOP/R

12.Personnel: qualification, training, clothing and hygiene.

13.Pest control: SOP/R.

14.Internal labelling SOP.

15.Batch numbering:SOP

16.RM/PM:Receipt, storing,sampling and dispensing SOP

17.RM/PM/finished product: sampling record.

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18.RM/PM/Finished product: testing standard testing procedure.

19. RM/PM/Finished product:testing record.

20.Record:Retentio and disposal record.

21.Control manufacturing, analysis record.

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all above 21 documents.

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Definition:

It is a system of procedure where in changes made in quality system are reviewed, justified, documented and approved.

It shall conform to corporate and regulatory requirement.

Need of change:

is required when the is increase in:

1)Rejection i.e. process has shifted

2)Complaints.

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change made should affects 1)validated condition: of process

,system,control. 2)product quality and safety 3)Regulatory commitment. Priciple of change control: 1)Name of initiator/proposer of change i.e.

identity the owner of change. 2)Review and approval of change: change is reviewed justified and approved.

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3)Prevent adverse affect: prevent changes affecting adversely on quality safety and regulatory aspect.

Types of change control:

1)change control : such changes are planned to control the quality.

2)Deviation control: such changes are unplanned.some deviations have taken place in the system, they are controlled by taken by D

''Deviation contol procedure''.

Procedure:

steps involved in change control.

1) Initiation/proposing change:

To improve the quality reduce rejection make complaint one person initiates or proposes or suggests a change control.

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He gives the description, justificational and adequacy.

2)Review of changes : affect on:

1) quality , safety of product.

2)validated system: process control system

3)regulatory aspect /commitment.

3)Approval of change control:

Authorised if found suitable.

4)Implement change control:

5)monitor the change control:

Whether is regularly giving good results, otherwise stop, review.

6)Train personnel:

change in procedure etc.done due change control so new training for new procedure is given.

7)Retain :

frequency to avoid mistakes in implementing change control.

Document required:

SOP/R: change control procedure.

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It is a document it gives factual and complete information regarding site of

pharma manufacturing plant. it may range up to 100 pages or less , brief information is

desired. Content: universally accepted contents are : 1.0.General information 1.1Name and address of site 1.2Description of site 1.3brief information about organisation 1.4pharmaceutical manufacturing activities 1.5 other manufacturing activities 1.6types of products manufactured at site 1.7employees details 1.8external assistance 1.9quality management system 2.o PERSONNEL: 2.1organisation chart

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2.2key personnel:Qualification, experience ,responsibilities

2.3training (basic ,in-service ) 2.4heath requirement :for personnel engaged in

manufacturing 2.5clothing 3.o premises and equipement: 3.1description of manufacturing area 3.2nature of construction and finished 3.4 maintenance of premises 3.5measure production and laboratory equipement 3.6maintenance of equipent 3.7calibration system 3.8sanitation 3.9special area 3.10water system 3.11brief description of ventillation system (HVAC

system)

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4.1 preparation ,revision,distribution of document

4.2 other document related to product quality

4.3 additional document

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5.1brief description of production operation

5.2handelling of materials

5.3handeling of rejected material and products

5.4brief description of general policy for process validation

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6.1

quality management system

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7.1contract manufacturing

7.2contract analysis

7.3contract services

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8.1 product distribution

8.2 product complaint handling

8.3 product recall

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9.1

self inspection programme

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10.1product exported to different countries

10.2complaints and product recall if any

DOCUMENTS REQUIRED

1.site master file

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