Standard Operating Procedure for Documentation and Record Keeping

1) Purpose

The purpose of this SOP is to establish procedures for the creation, maintenance, and retention of documentation and records to ensure accuracy, integrity, and regulatory compliance.

2) Scope

This SOP applies to all personnel involved in documentation and record keeping at [Company Name] for the production of intramuscular, subcutaneous, and intravenous injection products.

3) Responsibilities

The responsibilities of this SOP include:
– All Personnel: Creating and maintaining accurate and complete records.
– Quality Assurance (QA) Department: Reviewing and approving documentation and ensuring compliance with regulatory requirements.

4) Procedure

4.1 Creation of Documents
4.1.1 Create documents using approved templates and formats.
4.1.2 Ensure all documents are clear, accurate, and complete.
4.2 Review and Approval of Documents
4.2.1 Submit documents to the QA department for review.
4.2.2 QA to review and approve documents for accuracy, completeness, and compliance with regulatory requirements.
4.3 Maintenance of Records
4.3.1 Store records in designated areas to ensure they are protected from damage or loss.
4.3.2 Maintain records in an organized manner to facilitate easy retrieval.
4.4 Retention of Records
4.4.1 Retain records for the duration specified in the company’s record retention policy or as required by regulatory guidelines.
4.4.2 Dispose of records that are no longer required in a secure and compliant manner.
4.5 Documentation Controls
4.5.1 Implement controls to prevent unauthorized access, alteration, or loss of records.
4.5.2 Ensure all changes to documents are authorized, documented, and traceable.

5) Abbreviations, if any

– QA: Quality Assurance

6) Documents, if any

– Document Templates
– Record Retention Policy
– Document Control Logs

7) Reference, if any

– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards

8) SOP Version

Version 1.0