Record Keeping and Documentation – Standard Operating Procedure

1) Purpose

To establish guidelines for the systematic management, retention, and accessibility of records and documentation within the pharmaceutical purchase department.

2) Scope

This SOP applies to all records and documents generated or maintained as part of procurement activities for pharmaceutical manufacturing and related functions.

3) Responsibilities

Records Management Team: Responsible for overseeing record keeping and documentation practices.
Procurement Team: Responsible for generating, maintaining, and archiving procurement-related documents.

4) Procedure

4.1) Document Identification and Classification:
4.1.1) Identify documents generated or received during procurement activities (e.g., purchase orders, contracts, invoices).
4.1.2) Classify documents based on their type, importance, and retention requirements.

4.2) Document Creation and Control:
4.2.1) Create documents using standardized templates and formats to ensure consistency and clarity.
4.2.2) Implement document control measures, including version control and approval workflows.

4.3) Document Storage and Access:
4.3.1) Store documents in a secure and organized manner to prevent loss, damage, or unauthorized access.
4.3.2) Establish access controls and permissions to ensure only authorized personnel can view or modify sensitive documents.

4.4) Record Retention and Disposal:
4.4.1) Define retention periods for