Standard Operating Procedure for Good Documentation Practices (GDP)
1) Purpose
This SOP outlines the principles and guidelines for maintaining accurate, complete, and traceable documentation throughout all stages of pharmaceutical manufacturing, ensuring data integrity, compliance with regulatory requirements, and support for quality assurance activities.
2) Scope
This SOP applies to all personnel involved in creating, reviewing, approving, distributing, and archiving documents within the company, including manufacturing, quality control, quality assurance, and regulatory affairs.
3) Responsibilities
All personnel are responsible for adhering to GDP principles and guidelines to ensure the integrity and reliability of documentation. The Quality Assurance (QA) department is responsible for overseeing GDP compliance and providing training as necessary.
4) Procedure
4.1 Documentation Practices
- Use approved document templates and formats for creating documents.
- Ensure all entries are legible, clear, and recorded in indelible ink or electronically documented as per company procedures.
- Avoid use of correction fluid/tape; instead, strike through errors neatly with a single line, date, and initial.
4.2 Document Identification and Control
- Assign unique document numbers or codes for identification.
- Control document revisions and ensure only current, approved versions are used.
- Archive obsolete documents securely and maintain revision history.
4.3 Document Review and Approval
- Ensure documents are reviewed and approved by authorized personnel before use.
- Obtain signatures or electronic approvals as per company procedures.
- Record document approvals and maintain documentation of review processes.
4.4 Document Distribution
- Distribute documents to authorized personnel only.
- Maintain distribution records and ensure controlled distribution lists are updated.
- Ensure immediate retrieval of obsolete or superseded documents.
4.5 Document Retention and Archiving
- Archive documents securely according to document retention policies.
- Ensure documents are stored in a manner that prevents loss, damage, or unauthorized access.
- Facilitate document retrieval for audits, inspections, and internal reviews.
5) Abbreviations, if any
GDP: Good Documentation Practices
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
Document Templates, Document Register, Distribution Lists, Document Retention Policy
7) Reference, if any
Regulatory guidelines such as FDA, EMA, ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients), and WHO Good Manufacturing Practices (GMP)
8) SOP Version
Version 1.0
