Standard Operating Procedure for Documentation in Granules Production

1) Purpose

The purpose of this SOP is to outline the procedures for documenting various activities and processes involved in granules production in the pharmaceutical industry to ensure traceability, accountability, and regulatory compliance.

2) Scope

This SOP applies to all personnel involved in documenting activities related to granules production within the pharmaceutical manufacturing facility.

3) Responsibilities

Production Supervisors: Responsible for overseeing documentation activities.
Quality Assurance: Responsible for ensuring documentation accuracy and compliance.
Documentation Specialists: Responsible for maintaining document control.

4) Procedure

1. Document Preparation:
   1. Prepare batch records, standard operating procedures (SOPs), and other required documents prior to production.
   2. Ensure documents are reviewed and approved by authorized personnel.
2. Recording of Data:
   1. Record all critical data points and observations during granules production in designated logbooks or electronic systems.
   2. Ensure entries are clear, accurate, and legible.
3. Review and Approval:
   1. Review production documentation for completeness and accuracy.
   2. Obtain approvals from relevant departments (e.g., Quality Control, Production).
4. Document Control:
   1. Maintain document control procedures to ensure documents are current and accessible.
   2. Archive documents according to retention schedules and ensure version control.
5. Training:
   1. Provide training to personnel on documentation procedures and requirements.
   2. Ensure awareness of regulatory standards and data integrity principles.
6. Audit and Compliance:
   1. Conduct periodic audits of documentation practices to verify compliance.
   2. Address any non-conformities identified during audits promptly.

5) Abbreviations, if any

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice

6) Documents, if any

Batch Records, SOPs, Document Control Logs

7) Reference, if any

Good Documentation Practices (GDP) guidelines and pharmaceutical regulations.

8) SOP Version

Version 1.0