A SEMINAR ON

DOCUMENTATION
Prepared By-
Riddham Patel,
M.Pharm Sem-I,
QA Department,
HNSIPER.
Guided By-
Poonam Thumar,
Faculty,
QA Department,
HNSIPER.
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CONTENTS
Why Documentation is necessary in pharma industry???
Aim of documentation
Inclusions Of Documentation !!!
Records
Labels
Specifications And Testing Procedures
Master Formulae
Packaging Instructions
Batch Production And Control Records (BPCR) / Batch
Manufacturing Records
Batch Packaging Records (BPR)
Site Master File
Standard Operating Procedures (SOPs)
References
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WHY DOCUMENTATION IS NECESSARY IN
PHARMACEUTICAL INDUSTRY???
Documentation is a key area for companies in the
pharmaceutical industry. The United States Food
and Drug Administration (FDA)-the governmental
agency, that is responsible for overseeing the
industry, requires extensive documentation for
every manufacturing and packaging lot of all
pharmaceutical products.
The FDA mandates documentation for the sake of
accountability and traceability.
This practice is to ensure safe and effective
pharmaceutical products.


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AIM OF DOCUMENTATION
To define the specification for all materials.
To define methods of manufacture and control.
To ensure that all personnel connected with
manufacturer and control know what to do and
when to do.
To ensure that the personnel authorized to release
a batch for sale or reject it, have all the information
that is necessary to take decision.
To provide information during investigation, if a
batch is suspected to have defect(s).
To make available data needed for validation ,
review and statistical analysis.
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INCLUSIONS OF DOCUMENTATION !!!
Revised schedule M has the following elements
which are related to documentation:-----
Records
Labels
Specifications And Testing Procedures
Master Formulae
Packaging Instructions
Batch Production and Control records (BPCR) / Batch
Manufacturing Records
Batch Packaging Records (BPR)
Standard Operating Procedures (SOPs)
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RECORDS
Records to be maintained
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RECORDS TO BE MAINTAINED
Receipt and issue records of raw materials and containers
Log book of assigning batch number
Analysis record (Generally by Q.C. department)
Finished product distribution records
Major critical equipment cleaning, maintenance, calibration,
validation records
House keeping, maintenance, cleaning and sanitization
records
Personnel matters including qualification, training etcetera
Environmental monitoring
Complaints
Recalls
Returns


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LABELS
Introduction
Label of finished product
Label of reference standard
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INTRODUCTION
In pharma industry, Labels are used for identification and/or status of
container, equipment and premises.
Labels should be unambiguous and in format approved by the
company.
Sometimes colored labels are used to indicate status. For Example,
colored labels for starting materials according to their status:
Quarantine - Yellow
Approved - Green
Rejected - Red




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LABEL OF FINISHED PRODUCT
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Name of product
Ingredients
Net Content
Batch number
Expiry date
Storage condition
Information about manufacturing company (Lice. No. and Address)
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LABEL OF REFERENCE STANDARD
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Name of material
Potency
Date of preparation
Batch number
Shelf-life
Storage condition
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SPECIFICATIONS AND TESTING
PROCEDURES
Introduction
Specifications for Raw Materials
Specifications for Finished Product
Specifications for Packaging Materials
Testing Procedures

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INTRODUCTION
It is a list of detailed requirements with which product/material
used or procedure followed during manufacture need to
conform.
They serve as basis for quality evaluation.
Specifications should be available for :

Raw Materials
Finished Products
Packaging Materials
First twos can be referred from their individual monographs
from pharmacopoeia.
If standard data is not available in pharmacopoeia, then
manufacturer can write specification himself.
Specifications for packaging materials such as plastic or glass
containers and closers etcetera, are not given by any
monograph. However certain requirements have been laid
down for them in appendix-11 of I.P.

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Bureau of Indian Standards (BIS) has prepared
specifications for various packaging materials.
These specifications are given prefix as IS, means
Indian Standard.
There are 18210 numbers of Indian Standards.
*

Certain specifications amongst them are specifically
prepared for pharmaceutical industry, while the rest
are general specifications.
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SPECIFICATIONS FOR RAW MATERIALS
Generic and chemical name of material
Trade name or product code established ny
manufacturer
Description
Name of pharmacopoeia or any other recognized
book of standards in which monograph appears or
INN (International Non-proprietary Name).
Approved supplier
Frequency of testing of stored material
Special precautions to be taken during storage
including safety aspects
Date of Issue of specifications 15
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SPECIFICATIONS FOR FINISHED PRODUCT
Generic name of product
Trade name
Dosage form and Strength
Description (Color, State, Dimension, Taste)
Physical properties ( Weight/Volume (with limit), pH,
Viscosity, Density, Hardness,
Friability, Disintegration time, `
Dissolution Time etcetera)
Name of Pharmacopoeia as a reference
Date of Expiry
Precautions during storage including safety aspects
Date of issue of specification 16
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SPECIFICATIONS FOR PACKAGING MATERIALS
Below mentioned Indian standards may referred,
while preparing specifications for packaging
materials:

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Number of IS Specification for
IS 7803 Plastic Containers
IS 3692 Rubber Closures
IS 1776 Folding Box Board
IS 2771 Corrugated Box
IS 3101 Collapsible Tubes
IS 7852 Eye Ointment Tubes
IS 10133 Glass Bottles
IS 8970 Paper Aluminum Foil
IS 8393 Pilfer Proof Closures
IS 1984 Glass Vials
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TESTING PROCEDURES
These are nothing but the procedures for testing
raw materials, intermediated and finished products.
These procedures are basically based on
Pharmaceutics and Analytical techniques.
While preparing these procedures Various
pharmacopoeia (like IP, BP, JP, EP, USP etc) and
other recognized books of standards like drug and
cosmetics rules, USNF, other authoritative books on
analysis of drugs.
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FORMAT FOR STANDARD TESTING
PROCEDURE
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Name : Pages:
Code No. : Shelf Life :
Status : Effective Date :
STP No. : Review Period :
Prepared By Checked By Approved By
Signature
Date
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MASTER FORMULAE
Definition
Preparation of Mater Formulae
Description
Sample of Master Formulae
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DEFINITION
Master formulae also can be said and written as
Master Formula Record, Manufacturing Formula,
Master Production and Control Record (MPCR)
etcetera.
It is defined as -
An approved master document that describes the full
process of manufacturing for the batch of specific
product.
It includes all the materials used in any batch
manufacturing and step by step process of
manufacturing.
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PREPARATION OF MATER FORMULAE
Master formulae can be prepared by competent
technical staff.
It should be reviewed by the heads of production,
quality control department and research &
development.
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DESCRIPTION
Name and Strength of the product along with dosage
form
MFR No.
A complete list of all ingredients with their quantity
Description of Containers, Closures and Packaging
materials to be used
Description of all Vessels and Equipments used in the
process
Processing and Packaging Instructions
IPQCs to be exercised during processing and packaging
Precautions to be taken during manufacture and storage
of semi-finished product including any special storage
conditions
Reference
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SAMPLE OF MASTER FORMULAE
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BATCH PRODUCTION AND CONTROL
RECORD (BPCR)
OR
BATCH MANUFACTURING RECORD
Definition
Notes about BPCR
Contents of BPCR
Sample For BPCR
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DEFINITION
Batch Processing Record can also be said as Batch
Manufacturing Record (BPCR) .
It is defined as
The Batch Manufacturing Record (BPCR) is the
necessary quality and GMP documentation for tracing
the complete cycle of manufacture of a batch or lot.
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NOTES ABOUT BPCR
BPCRs are required to be maintained for each
batch of the product manufactured.
These should be based on Master Formulae
records.
Methods of preparation of BPCR should be such
that trasncription errors do not occur.
Before any process begins, a check should be
made to ensure that all work stations are clear of
previous products, materials and documents. This
check should be recorded

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CONTENTS OF BPCR
The name and batch number of the product
Dates and times of commencement, of significant
intermediate stages and of completion of production
Identification (initials) of the operator(s) who performed each
significant step of the process and, where appropriate, the
name of any person who checked these operations
Quantities of each starting material actually weighed
A record of the in-process controls and the initials of the
person(s) carrying them
The product yield obtained at different and pertinent stages
of manufacture
Notes on special problems including details, with signed
authorization for any deviation from the Manufacturing
Formula and Processing Instructions
Approval by the person responsible for the processing
operations.


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BASIC DIFFERENCE B/W MPCR AND BPCR
MPCR is the type of master document, means with
the help of MPCR only, the BPCR is prepared
BPCR is unique batch wise, means all batches
have their individual BPCR.
Moreover BPCR contains Date and Time, that
when the batch was processed.
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BATCH PACKAGING RECORD
Introduction
Contents of BPR
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INTRODUCTION
In fact, BPR is a part of BPCR.
These records are based on packaging instructions.
One important operation that should be carried out
before packaging operation is line purging
(clearance).

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CONTENTS OF BPR
Name, Batch number and Qty. of bulk finished
product to be packed
Theoretical and Actual Yield and Reconciliation
The date and time of the packaging operation
The name of responsible person and his initials
Details of packaging instructions like equipments
and packaging lines used
Qty. along with identification of different printed
packaging materials issued, used, destroyed and/or
returned to store and reconciliation
In any case of problems, if any deviation made,
written authorization for the same
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SITE MASTER FILE
Introduction
Inclusions of Site Master File
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INTRODUCTION
Site Master File is a document, which gives a
complete information regarding a site of
pharmaceutical plant.
This document generally should not be very
massive, like running into more than 100 pages.
M.H.R.A. (Medicines and Healthcare products
Regulatory Agency), a government agency of U.K.,
has given certain guidelines for length of the format
for it.
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INCLUSIONS OF SMF
The Information about -
Company
Personnel
Premises and Equipment
Documentation
Production
Quality Control
Contract manufacture and analysis
Distribution, Complaints and Product Recalls
Regulatory inspections and self-inspections
Details of Annual Product Review
Change Control System
Technical Quality Agreement for Contract Manufacturing
(Technical Agreement, Quality Agreement)
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REFERENCES
How to Practice GMP, By P. P. Sharma.
Pharmaceutical Quality Assurance, By Manohar A.
Potdar.
Web Search Engines : Bing & Google
Web Encyclopedia : Wikipedia
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