Standard Operating Procedure for Documentation and Record-Keeping

Purpose

The purpose of this SOP is to establish procedures for the systematic and accurate documentation and record-keeping in pharmaceutical manufacturing, ensuring compliance with regulatory standards and maintaining data integrity.

Scope

This SOP applies to all personnel involved in the manufacturing and quality control of pharmaceutical products, including operators, technicians, and quality assurance personnel.

Responsibilities

• Operators: Responsible for accurately documenting critical information during manufacturing processes.
• Technicians: Responsible for maintaining and updating records related to equipment, processes, and quality control checks.
• Quality Assurance Personnel: Responsible for reviewing and approving documentation to ensure compliance.

Procedure

1. Ensure that all relevant documentation templates are available and up-to-date.
2. Document critical information during manufacturing processes, including but not limited to batch numbers, lot numbers, equipment used, and process parameters.
3. Use legible and permanent ink when recording information on paper documents.
4. For electronic documentation, follow the approved data entry procedures, ensuring accuracy and completeness.
5. Record any deviations from the established procedures or unexpected events, and initiate the deviation investigation process.
6. Maintain equipment logs, including calibration records, to ensure that all equipment used in manufacturing is in a validated and calibrated state.
7. Store all documents in designated and secure areas to prevent loss, damage, or unauthorized access.
8. Ensure that document revisions are appropriately tracked, and only the latest version is used for reference.
9. Regularly review and update documentation practices based on industry standards or process changes.
10. Conduct periodic training for personnel involved in documentation to ensure awareness of proper procedures and data integrity principles.
11. During audits or inspections, provide access to all relevant documentation and records for review by authorized personnel.
12. Archive records in accordance with established retention policies.
13. Implement corrective actions based on findings from document reviews, audits, or inspections.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Batch Records
• Equipment Logbook
• Calibration Records
• Deviation Reports
• Training Records

Reference

Good Documentation Practices (GDP) guidelines

SOP Version

Version 1.0