documentation in pharmaceutical industry

1. Documentation In
Pharmaceutical Industry
By Arunima Nag
Assistant professor in pharmaceutics
Bengal school of Technology
(College of pharmacy)

2. Introduction to
Documentation in the
Pharmaceutical Industry
Documentation in the pharmaceutical industry plays a crucial role in
maintaining quality, compliance, and safety standards. It
encompasses standard operating procedures (SOP), quality audits,
review of quality documentation, and the generation of various reports
and distribution records.
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3. Document
Definition:
Method of preparing a written material, which describes the process in terms of
specifications, instructions etc.
The D & C Act under conditions of granting license and schedule M require
manufacturer of drugs to maintain various records.
Importance of documentation:
• Provides necessary working details
• Reduces the risk of mistake
• Helps in decreasing batch to batch variation
• Considered as the history of batch operations

4. Types of Documents
▪ Commitment document : Relationship between industry and the regulatory
authorities.
• Directive document : Relationship between management and employee.
• Record document : Relationship between the employee and the work they
perform.

5. Master Formula Records (MFR)
Written procedure that give the complete description of all aspects of
manufacture, packing and control with an inspection to ensure purity, identity,
quality and strength of each dosage unit through its shelf life.
Includes all the materials used in any batch manufacturing and step by step
process of manufacturing.

6. The Master Formula Include:
a) The name of the product together with product reference code relating to its specifications.
b) The patent or proprietary name of the product along with the generic name, a description of
dosage form, strength, composition of the product and batch size.
c) A statement of the processing location and the principal equipment to be used.
d) Name, quantity and reference number of all starting materials to be used.
e) A statement of expected final yield with the acceptable limits and of relevant intermediate yields,
where applicable.
f) The methods or reference of the methods to be used for preparing the critical equipment
including cleaning, assembling, calibrating, sterilizing.
g) Detailed stepwise processing instructions and the time taken for each step

7. Types of Master Formula Records (MFR):
➢ The master formula records gives proportion of ingredients in the
formulation.
1. Master batch formula records:
Specify absolute amounts of specific potent ingredients and excipients in a
batch.

8. 2. Master production and control
records:
• Detailed written instructions including all operations starting from
dispensing of raw materials till finishing of bulk products and
packaging operation of the particular product.
• It includes batch size, date of manufacture and full signature by 1st
person and further independently checked, dated and signed by 2nd
person.

9. Preparation of master formula :
• Master formula can be prepared by competent technical staff.
• It should be reviewed by the head of production, QC department and
R & D department

10. Distribution records
Written procedures shall be established and followed, describing the distribution of drug products Include:
1. A procedure where by the oldest approved stock of a drug product is distributed first
2. A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if
necessary.
Distribution records must be constructed and procedures established to facilitate recall of defective product.
All records should be indexed by either the manufacturing batch-lot number of the packaging control number as a
means of accountability.
It shall contains:
▪ Name and strength of the product
▪ Description of dosage form
▪ Name and address of the consigner
▪ Date and qty shipped
▪ Lot and control number of the drug

11. WHO guidelines for distribution records:
• Written instruments and records should be available.
• Procedure should be established and maintained.
• The title, name and purpose of each document should be clearly stated.
• All documents should be completed, approved ,signed ad dated by an
appropriate authorized persons.
• In the case of temperature-sensitivity pharmaceutical products, records
of investigations and actions should be retained for at least one year
after the expiry date of the product.

12. Standard Operating Procedures (SOPs)
Definition:
• Standard Operating Procedures (SOPs) are step-by-step instructions that outline how
tasks should be performed to ensure compliance with industry standards and regulations.
Purpose:
• SOPs help maintain consistency, reduce errors, and ensure that all employees understand
and adhere to established processes.
Components:
• SOPs typically include a title, scope, purpose, responsibilities, procedures, and references
for guidance.

13. Quality audit documentation
Evidence
Collection
Gathering and
documenting evidence of
compliance during the
audit process.
Comprehensive
Reporting
Creation of detailed reports
documenting findings and
recommendations for
improvement.
Audit Trail
Documentation
Recording and maintaining
a comprehensive audit trail
for transparency and
accountability.

14. Quality Audit
Quality Audit is defined as a systematic and independent
examination to determine whether quality activities and related
results comply with planned arrangements, and whether these
arrangements are implemented effectively and are suitable to
achieve objectives

15. Types Of Quality Audit
The quality audit system mainly classified in following different categories:-
1. Internal Audit
2. External Audit
3. Second Party Audits
4. Third Party Audits
5. Process Audits
6. Product Audits
7. System Audits

16. Internal Audit
▪ Ensure that an organization is meeting its own quality standards or
contractually required standards.(called a first party audit).
Done by auditors who work for the company.
▪ They may also be hired by the company to audit its own functions.
▪ Auditors must be independent of the function they are auditing.
(this type audit by company employees, consultants and
contactors)

17. Purpose of Internal audit
1. To ensure that adequate Quality systems are maintained.
2. To ensure compliance with the C-GMP's and firms standard
operating procedure.
3. To achieve consistency between manufacturing and testing facilities.
4. To identify problems internally and Correct problems prior to a FDA
inspection.

18. External Audits
❑ External auditors are separate from the company.
❑ They may be hired by a supplier or customer to ensure that the audited
company meets their quality standards.
❑ They may be audited by the government to verify that they meet military
specifications.
❑ External audits can be done by quality consultants specializing in the quality
standards for those organizations.

19. Purpose of External Audit
- Confidence in the partnership arrangement.
- Ensuring that requirements are understood.
- Reducing the risk of failure.
-Carried out by company on its vendors. No legal requirement to
conduct the audit.
- External audit have experience of GMP as well as regularly audited
by their certification body

20. OTHER TYPES OF QUALITY AUDIT
• Second Party Audits-
External audits done by a company that has a contract with the
audited firm is called a second party audit.
• Third Party Audits-
External quality audits done by an organization that has no
contract with the company it is auditing is called a third party
audit.
• Process Audits-
A process audit verifies that a documented process meets
quality standards. This process could be a manufacturing
process or service process.

21. OTHER TYPES OF QUALITY AUDIT
• Product Audits-
A product quality audit verifies that a physical product meets
design specifications and other quality measurements,
measuring physical dimensions, product testing, or destructive
testing, checking the calibration and test equipment used to
verify that the product meets quality standards.
• System Audits-
It is a review of how quality standards are measured and met by
the company. It verifies the procedures used to measure the
quality of the product, how defects are recorded, and how the
company ensures that failed product is not passed.

22. QUALITY REVIEW
• Quality review is planned and documented inspections of a review system i.e., “Process of
reviewing all specifications at all in-process check points are met and all documentation with
signatures are incorporated in Batch record.”
• The review item may be product, a group of related products or a part of a product.
• The earlier an error is identified the less costly are the implications and the penalty for
failing to conduct adequate reviews.
• The US Food and Drug Administration proposed the requirement in 13 February 1976 rewriting
of the GMPs. The purpose was to provide reliable procedure for a drug manufacturer to review
the quality standard.
• Quality Review was published in September 1978 final current GMP's (cGMP)regulation for
drug product and became effective on 28 March’1979.

23. PRINCIPLE:
• QR studies indicate the product is within the specified limits.
• QR all documents to be sure there are no loose ends and also
examines testing data to confirm that the product meets
specifications.
• If there is significant problem with the product, GMPs require
the QC group to reject the product and investigate.

24. OBJECTIVES:
1. Product Specification.
2. Identification of improvement.
3. High Lightening trends.
4. Appropriateness of starting material requirement
specifications.

25. Specific procedures to be checked:
1. Foreign matter in production area
2. Correct amounts of correct ingredients and their correct addition
3. Separation of one lot from others
4. Maintenance of specific storage conditions
5. Cleaning of containers and equipments before use and after
fourth cycle
6. Covering of equipments in production
7. Storing production equipments on rack

26. Specific procedures to be checked:
8. Personnel ready for task
9. Production meeting with specifications
10. Clean production area
11. Safety procedures
12. Dust control equipments
13. Supplying sealed containers until production begins and removed after
emptying
14. Sterile manufacturing guidelines are followed

27. Review of records:
Material Records
Production
records
In process
records
Laboratory
records
Stability testing
of Finished
products

28. PHASES IN QR:
QR should be seen as a 3-Phase process
➢ Phase-1-----------Preparation
➢ Phase-2-----------Review meeting
➢ Phase-3-----------Follow up

29. PHASES IN QR:
PHASE-1
• It is the responsibility of the chairman and presenter to organize
the Q.R and notify all reviewers invited.
• Invitation and copies of the products being reviewed should be
issued, allowing sufficient time for each reviewer to compile an
error list.

30. PHASES IN QR:
PHASE - 2:
•Error list and copies of annotated products should be brought to the meeting by
each reviewer.
• During the review meeting the emphasis should be on error detection, in line
with the criteria, and only limited discussion of corrective action should occur.
• It is important that 'personalities' and 'politics' are kept out of the review.
For reviews that are 'complete' the action list tasks are allocated along with
designated reviewers, to verify that the work is done.
• A project exception report should be raised for any errors detected in non-review
items.

31. PHASES IN QR:
PHASE - 3:
• Follow up period during which the errors identified at the review
that were committed to follow up action list are rectified and
signed off.
• At the end of the follow up period 'which is typically restricted to
one week, the follow up action list should be signed off by the
chairman.

32. 4M CONCEPT
✓ Man
✓ Machinery
✓ Method
✓ Material

33. Quality Documentation Requirements
In the pharmaceutical industry, quality documentation requirements are critical for
maintaining compliance with regulations and ensuring the safety and efficacy of
products. Documentation must be comprehensive, accurate, and up-to-date to support
quality assurance processes.
Quality documentation includes batch records, test results, stability data, and
validation documentation. It must adhere to Good Manufacturing Practices (GMP) and
other relevant standards to demonstrate product quality and consistency.

34. Reports and documents in the pharmaceutical
pharmaceutical industry
Research Reports
Comprehensive reports
detailing findings from
pharmaceutical research
studies, including efficacy,
safety, and potential impacts
on the industry.
Manufacturing
Documentation
Detailed records of the
pharmaceutical
manufacturing process,
including batch records,
packaging information, and
quality control documents.
Regulatory Compliance
Documents
Documented evidence of
compliance with regulatory
requirements to ensure the
safety, efficacy, and quality of
pharmaceutical products.

35. Distribution record documentation
Accurate Record
Keeping
It is essential to maintain
precise records of the
distribution process,
including batch numbers,
expiration dates, and
destinations.
Compliance with
Regulations
Distribution records must
adhere to strict regulatory
standards to ensure the
safety and quality of
pharmaceutical products
throughout the supply chain.
Traceability and
Accountability
Documentation enables
traceability, allowing for swift
identification and recall of
products in case of quality
issues or safety concerns.

36. ImportanceofAccurateandComplete
CompleteDocumentation
Regulatory Compliance
Accurate documentation ensures
compliance with regulatory
standards, which is vital for
pharmaceutical operations.
Patient Safety
Complete documentation directly
impacts patient safety, ensuring the
right medications reach the right
patients.
Quality Assurance
It is crucial for maintaining the quality and efficacy of pharmaceutical products
throughout their lifecycle.

37. Challenges in maintaining documentation in the
pharmaceutical industry
1
Regulatory Compliance
Adhering to constantly evolving regulations
2
Data Accuracy
Ensuring precise and error-free information
3
Document Security
Protecting sensitive information from
unauthorized access

38. Best Practices for Effective Documentation
Management
Organization
Establish a systematic
filing and naming
convention for
documents to ensure
easy retrieval and
tracking.
Collaboration
Encourage cross-
functional
collaboration to
ensure input from all
relevant stakeholders
for comprehensive
documentation.
Security
Implement strict
access controls and
encryption to
safeguard sensitive
information
contained in
documentation.
Regular Audits
Conduct regular
audits to ensure
compliance with
documentation
standards and
identify areas for
improvement.

39. Thank You.