This document discusses pharmaceutical documentation. It defines documentation and its aims which include defining specifications, procedures, and ensuring authorized persons have necessary information. There are different types of documentation like policy documents, specifications, procedures, work instructions, and records. The document also outlines the documentation process including preparation, review, approval, distribution and revision. It describes how mistakes are corrected in documentation and concludes that documentation provides a basis for planning future manufacturing functions in a GMP environment.

1. DOCUMENTATION
Presented by
BINU ANAND
FIRST YEAR M.PHARM
NAZARETH COLLEGE OFPHARMACY

2. Introduction
2
• “Document” is a written report or record that provides
information especially of an official or legal nature.
• The term derived from Latin “documentum” and “doceo”
refers to “an example meant to teach, both for giving
instructions and for warning purposes.”
• “Documentation” is a method of preparing a written material,
which describes the process in terms of specification,
instructions etc.”

3. Aims of Documentation
3
 To define the specifications and procedures for all materials.
 To define methods of manufacture and control.
 To ensure that all personal concern 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 realize a batch of a drug
for sale.
 To ensure the availability of the data needed for validation ,
review and statistical analysis.

4. Types of Documentation
4
Policy Documents
Specifications
Procedures
Work Instructions
Records

5. • Policy document : It gives the company overview to aid continuing
the organization with policy.
• Specifications : Are the documents which describe all materials in
terms of their chemical physical and biological characters, and it also
includes standards and permitted tolerance.
• Procedures : Are formal written instructions which detail how an
operation is to be performed.
5

6. • Work instructions : Are batch related documents which list all
the starting material to be used and production operations.
• Records : Are completed documents, reports, instructions,
protocols, log books, log sheet etc. which are used to record
information. They provide a history of each batch of product.
6

7. 7
Document Preparation and Control
Process
Preparation
Review
Issue
Distribution
Revision Approval

8. Procedure For Documentation
8
The preparation of document is best done by those involved in and
who are familiar with the processes or procedures. There should be a
guide to the preparation of all types of documentation in the form of
SOPs.
Indexing and numbering:
 Master document should be indexed.
 Editions of documentation should be differentiated.
 A computer database can be used.

9. 9
Approval of documentation
• Approved by authorized persons.
• The level of authority of approvers will depend on the
document in question, and the scope of their approval.
Distribution and control of copies
• Copies of procedures should be available in the relevant
departments.
• Should be reviewed and updated.

10. 10
• There should be method of authenticating official copies and
maintaining a list of recipients and issue and return date.
Documentation review
• For regular updating of all procedures.
• Carried out by those who are directly involved.
• Batch related documentation should be reviewed frequently.
• Changes should be approved.

11. 11
Organization
• One department should have control of documentation and
archiving.
Storage and archiving
• Done by using hard copy, magnetic disc, micro film or optical
disc.
• Duplicate copies should be made and kept in separate location.
• Batch related documentation should be stored at least 6 years
beyond the manufacture date of the batch.

12. • Draw a single line through the
error
• Make the correction next to the
error
• Write an explanation for the error
• Sign and date the correction.
How are mistakes corrected?

13. CONCLUSION
• Documentation helps to build up a detailed picture of what a
manufacturing function has done in the past and what it is
doing now and, thus, it provides a basis for planning what it is
going to do in the future.
• In a GMP environment documentation needs to meet certain
requirements to ensure product quality and product safety.

14. REFERENCES
14
• Pharmaceutical Production and Management, CVS Subrahmanyam,
Page no. 443-445.
• Berger David “Procedures and Documentation”, retrieved 15 June
2009.
• An Article Of Pharmaceutical Documentation Monograph, 1995,
The Institute Of Quality Assurance.