Chapter 4, Documentation.pdf

EUROPEAN COMMISSION
HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Public Health and Risk Assessment
Pharmaceuticals
Brussels,
SANCO/C8/AM/sl/ares(2010)1064587
EudraLex
The Rules Governing Medicinal Products in the European Union
Volume 4
Good Manufacturing Practice
Medicinal Products for Human and Veterinary Use
Chapter 4: Documentation
Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC and Article 51 of Directive 2001/82/EC.
Status of the document: revision 1
Reasons for changes: revisions to "generation and control of documentation" and "retention of documents" due to increasing use of electronic documents.
Deadline for coming into operation: 30 June 2011
Good documentation is essential for quality assurance and GMP compliance, and should be defined in the manufacturer's Quality Management System.
There are two primary types of documentation: instructions and records/reports.
Required GMP documentation includes: Site Master File, Specifications, Manufacturing Formulae, Procedures, Protocols, Technical Agreements, Records, Certificates of Analysis, and Reports.
Generation and Control of Documentation should ensure accuracy, integrity, availability, and legibility of documents.
Documents should be designed, prepared, reviewed, and distributed with care, and should comply with relevant parts of Product Specification Files and Manufacturing and Marketing Authorisation dossiers.
Good Documentation Practices include regular review and update of documents, clear and legible handwritten entries, and making records at the time of each action.
Retention of Documents should clearly define which record is related to each manufacturing activity and where it is located.