NAVIN K KHARE
(BPCR.32,CHANGE CONTROL 39)
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7.0.Introduction
STEPS 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
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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 experts
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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
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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 history
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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 the
documents
❖ 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:
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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 Ingredient specificati Overage Weight for Weight for
s on tab batch at
1.0 lakh
Tab
1 Paracetam IP 1% 505 50.0
ol
2 Nitrocryst IP – 10 1.0
aline
cellulose
3 Starch IP – 25 2.5
4 Talc IP – 5 0.50
5 Magnesiu IP – 5 0.5
m stereate
6 Total 550 50.500
Remark:
Paracetamol with bulk density not less than 0.8gm/cc is to be
used.
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Microcrystalline cellulose:sieve size 325
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 Wastage
Tab(Nos)
1 Label (60 100 5
*100mm)
2 Tin 100 1
container(dia
150mm*height:
180mm)
3 Shipper 10 –
box(L:500*w
300 *ht
200mm)
4 .Box label 10 1
•Printed packin(6g0 *m10a0tmemri)a l 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)
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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.R
Batch 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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