Documentation
- 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.