The document discusses the importance of documentation in the pharmaceutical industry. It states that documentation provides evidence of activities and ensures quality assurance. Good documentation includes specifications, procedures, and information to ensure manufacturing processes are followed correctly. It also discusses the types of documents needed like batch production records, master formulas, standard operating procedures, distribution records, and emphasizes that documents must be properly designed, approved, distributed and updated to ensure compliance.

1. DOCUMENT
MAINTENANCE IN
PHARMACEUTICAL
INDUSTRY
SUBJECT: Pharmaceutical quality assurance
SUBJECT INCHARGE: Ms. Ashwini U. Bhoir
Assistant professor
in pharmaceutics

2. INTRODUCTION
• “If it's not written down, then it didn't happen”
• Document is any written statement or proof of any activity in
pharmaceuticals.
• The basic rules in any good manufacturing practice (GMP)
regulations specify that the pharmaceutical manufacturer must
maintain proper documentation and records.
• Good documentation is an essential part of the quality
assurance system.

3. Aims:
• To define the specifications and procedures for all materials
and methods of manufacture and control
• To ensure that all personnel concerned with manufacture
know what to do and when to do it,
• To ensure that authorized persons have all the information
necessary to decide whether or not to release a batch of a
drug for sale.
• To ensures documented evidence, traceability, provide
records and audit trail for investigation.
• To ensures availability of data for validation, review and
statistical analysis.

4. General Principle of Documentations:
Design (correct, complete, current and traceable)
Prepared
Reviewed
Proper distribution
Document: As discrete packages of recorded information are
the tools of quality.
Used to establish standard specification and processes that
assures compliance with standard specifications and
processes. Quality cannot be assured in a regulated industry
without good documents and good documentation practices.

5. Documents are the Backbone of the Quality System
Verbal instructions often are:
Not heard,
Misunderstood,
Quickly forgotten,
Ignored.

6. Essential Characteristics:
• The documents are permanent evidence of accurate, legible,
consistent information which is able to provide direct,
understandable and truthful information.
• To design an effective and efficient documentation process
firstly the important characteristics of processing event should
be identified.
• The document guiding for the manufacturing process, should be
in compliance w.r.t. current regulatory commitments the agency,
• The data should be accessible to everyone who needs to review
it, audit it or use it to perform trending analysis.

7. Types of Documents
Commitment
documents
Directive
documents.
Record
documents.

8. Requirement for good documentation:
Approval: Approval is required particularly in case of work
instructions, procedures, manufacturing formulae and
specifications of material and equipment.
Approval should be provided by the relevant personnel to ensure
the compliance of documents with the principles of GMP and
other regulatory authorities.
Clarity: Documents should be clear and in understandable form
misinterpretation by the users, particularly in case of
manufacturing process.
Chances of errors.

9. Requirement for good documentation:
Update: Documents must be kept up-to-date with changes in
regulations or processes and should be distributed in a controlled
manner to ensure that only the most recent versions are
available for use. They must also be available to those who need
them, where they need them.
Formal Presentation: Controlled documents should be prepared
according to the written procedure. Nowadays, computerized
documentation control system is being used or the compilation
and storage of documentation.

10. BATCH FORMULA RECORD (BFR) /
BATCH PRODUCTION RECORD(BPR) /
BATCH PROCESSING AND CONTROL RECORDS(BPCR)
/
BATCH MANUFACTURING RECORD (BMR)

11. BATCH FORMULA RECORD (BFR) / BATCH
PRODUCTION RECORD(BPR) / BATCH PROCESSING
AND CONTROL RECORDS(BPCR) / BATCH
MANUFACTURING RECORD (BMR)
• A document designed to provide a complete record of the
manufacturing history of a batch of product.
• Should be prepared for each intermediate, API / formulation
or product and should include complete information
relating to the production and control of each batch.
• It should be based on the relevant parts of the currently
approved specifications on the record.

12. BATCH FORMULA RECORD (BFR) / BATCH
PRODUCTION RECORD (BPR) / BATCH PROCESSING
AND CONTROL RECORDS(BPCR) / BATCH
MANUFACTURING RECORD (BMR)
• The method of preparation of such records should be
designed to avoid errors.
• The batch production record should be checked before issuance
to ensure that it is the correct version and a legible accurate
reproduction of the appropriate master production
instruction.

13. BATCH FORMULA RECORD (BFR) / BATCH
PRODUCTION RECORD(BPR) / BATCH PROCESSING
AND CONTROL RECORDS(BPCR) /
BATCHMANUFACTURING RECORD (BMR)
• If the batch production record is produced from a separate
part of the master document, that document should include a
reference to the current master production instruction being
used.
• Before any processing begins, a check should be made that the
equipment and work station are clear of previous products,
documents, or materials not required for the planned process,
and that the equipment is clean and suitable for use.

14. BATCH FORMULA RECORD (BFR) / BATCH
PRODUCTION RECORD(BPR) / BATCH PROCESSING
AND CONTROL RECORDS(BPCR) /
BATCHMANUFACTURING RECORD (BMR)
• This check should be recorded.
• During processing, the following information should be
recorded at the time each action is taken, and after completion
the record should be dated and signed by the person responsible
for the processing operations:

15. BATCH FORMULA RECORD (BFR) / BATCH
PRODUCTION RECORD(BPR) / BATCH PROCESSING
AND CONTROL RECORDS(BPCR) /
BATCHMANUFACTURING RECORD (BMR)
• These records should be numbered with a unique batch or
identification number, dated and signed when issued. In
continuous production, the product code together with the
date and time can serve as the unique identifier until the final
number is allocated.

16. BATCH FORMULA RECORD (BFR) / BATCH
PRODUCTION RECORD(BPR) / BATCH PROCESSING
AND CONTROL RECORDS(BPCR) /
BATCHMANUFACTURING RECORD (BMR)
• Documentation of completion of each significant step in the
batch production records (batch production and control
records) should include:
• Dates and, when appropriate, times.
• Identity of major equipment (e.g., reactors, driers, mills, etc.)
used
• Specific identification of each batch, including weights,
measures, and batch numbers of raw materials, intermediates,
or any reprocessed materials used during manufacturing.

17. • Actual results recorded for critical process parameters.
• Any sampling performed.
• Signatures of the persons performing and directly supervising or
checking each critical step in the operation.
• In-process and laboratory test results.
• Actual yield at appropriate phases or times.

18. • Description of packaging and label for intermediate or API or product
• Representative label of API or intermediate if made commercially
available.
• Any deviation noted, its evaluation, investigation conducted (if
appropriate) or reference to that investigation if stored separately.
• Results of release testing.
• All analytical records relating to the batch, or a reference that will
permit their retrieval.
• Decision for the release or rejection of the batch, with the date and
signature of the person responsible for the decision.
• The production record review.

19. MASTER FORMULA RECORD (MFR) / MASTER
PRODUCTION INSTRUCTIONS/MASTER PRODUCTION
AND CONTROL RECORDS (MPCR)/MASTER FORMULA
CARD (MFC)
• A master document for any pharmaceutical product it contains
all information about the manufacturing process for the product
• It is prepared by the research and development team of the
company and all other documents like BMR and BPR are
prepared using MFR by the manufacturing units.
• A formally authorized master formula should exist for each
product and batch size to be manufactured

20. • To ensure uniformity from batch to batch, master
production instructions for each intermediate or
API/finished product should be prepared, dated, and signed
by one person and independently checked, dated, and
signed by a second person in the quality unit.
• Competent persons experienced in production and quality
control should be responsible for the content and
distribution within the firm of instructions and master
formulae. These should be duly signed and dated.

21. • Outdated master formulae should be withdrawn but retained
for reference.
• Copies of the master formula should be prepared in a manner
that will eliminate any possibility of transcription error.
• In certain circumstances, for example, in the first production
runs following pilot development, the master formula might
need to be amended.
• Processing should be carried out in accordance with the master
formula.

22. • Master production instructions should include:
 The name of the intermediate/API/formulation
being manufactured and an identifying document
reference code, if applicable.
 A complete list of raw materials and intermediates
(designated names or codes sufficiently specific to
identify any special quality characteristics).
 An accurate statement of the quantity or ratio of
each raw material or intermediate to be used,
including the unit of measure.
• The production location and major production equipment to be
used

23. • Detailed production instructions, including the:
• Sequences to be followed
• Ranges of process parameters to be used
• The methods, or reference to the methods, to be used for
preparing the critical equipment (e.g.. cleaning, assembling)
• Sampling instructions and in-process controls, with their
acceptance criteria, where appropriate Time limits for
completion of individual processing steps and/or the total
process, where appropriate
• Expected yield ranges at appropriate phases of processing of
time.

24. STANDARD OPERATING PROCEDURE (SOP) AND
OTHER DOCUMENTS
If it isn't written down properly, it didn't happen either.
A standard operating procedure (SOP) is a set of step-by-step instructions
compiled by an organization to help workers carry out complex routine
operations,
SOPs aim to achieve efficiency, quality output and uniformity of while
reducing miscommunication and failure to comply with industry
regulations.
Benefits of SOP:

25. STANDARD OPERATING PROCEDURE (SOP) AND
OTHER DOCUMENTS
There is no right or wrong way to write an SOP, but for each SOP, you
should consider the following:
Objective
What is the
procedure
trying to
achieve?
Scope
What
should the
procedure
cover?
Process
Description
of how the
task is to be
carried out.
Responsibility
Who is
responsible
for carrying
out each
stage of the
process?
Training
Have staff
been
trained on
the SOPs
Review
Are SOPs
specific,
relevant
and up to
date?

26. STANDARD OPERATING PROCEDURE (SOP) AND
OTHER DOCUMENTS
Standard operating procedures and associated records of actions taken er
where appropriate, conclusions reached should be available for:
(a) Equipment assembly and validation;
(b) Analytical apparatus and calibration;
(c) Maintenance, cleaning and sanitization;
(d) Personnel matters including qualification, training, clothing and hygiene
(e) Environmental monitoring
(f) Pest control;
(g) Complaints;
(h) Recalls;
(i) Returns

27. STANDARD OPERATING PROCEDURE (SOP) AND
OTHER DOCUMENTS
TYPES OF SOP:
 Analytical method
 Preparation of Reagent
 Quality Assurance
 For operating instruments,
equipment and apparatus
 Safety & Precautions
 Methodic
 Receiving and registration of sample
 Fundamental SOP
 To deal with complaints
DO’s i. Write in present tense
ii. Avoid ambiguity and be concise
iii. Reduce the word count where
possible without changing the
meaning of the text
iv. Keep the words short and get to
point
v. Highlight exception. Use a
symbol to flag that this is an
exception and how to handle it
vi. Highlight warning and use a
larger or a warning icon.

28. STANDARD OPERATING PROCEDURE (SOP) AND
OTHER DOCUMENTS
DON’Ts
i. Don’t use past tense, condition of future tense unless you have good
reason to do so
ii. Introduce acronyms without explaining what it means.
iii. Don’t use the word “may” “if possible” as it implies that the user can do
something under conditions. Instead be positive and tell them what to do

29. STANDARD OPERATING PROCEDURE (SOP) AND
OTHER DOCUMENTS
CONTENT OF SOP:
• Company name and pagination
• Title
• Identification
• Review and approval
• Purpose
• Scope
• Responsibility
• Procedure
SOP PROCESS:
• SOP preparation
• SOP Review and Approval
• Frequency of revisions and
reviews
• Implementing SOP
• Management of SOP

30. DISTRIBUTION RECORDS:
Distribution records shall contain the name and strength of the product and
description of the dosage form, name and address of the consignee, date and
quantity shipped, and lot or control number of the drug product.
For compressed medical gas products, distribution records are not required
to contain lot or control numbers.

31. • The primary purpose: To ensure that adequate data are available
to access trade customers should a recall be initiated.
• The recording of dates on which a specific lot of product
commenced and ceased distribution may be used.
• All customers receiving the product between these dates could
then be contacted.

32. • Obviously on the first and last days of distribution, some of the
customers may have received product from the end of the
previous lot or the beginning of the next lot.
• Distribution records include a wide range of documentation such
as invoices, bills of lading customer’s receipts, and internal
warehouse storage and inventory records.

33. • The information required need not be on every document. Also,
customer codes and product codes may be used as alternates
to customer names and addresses and product names.
• Records for distribution shall be maintained in a manner such
that finished batch of a drug can be traced to the retain level to
facilitate prompt and complete recall of the batch, if and when
necessary.

34. • Particular in distribution records:
1. Name
2. Dosage forms and strength of the
consignment
3. The quantity of a pharmaceuticals
made by one manufacturer and
supplied at one time in response to a
particular request or order.
4. Name and address of consignee
5. Date and quantity shipped
6. Name, address and number of the
customer that the product is shipped
7. Delivery order, delivery date
and number
8. Quantity
9. Product batch number
10.Expiry date
11.Date of dispatch
12.Quantity of the products
13.Special storage requirements
14.A unique number