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 different types of records based on regulatory requirements and organizational policies.
4.4.2) Implement procedures for the secure disposal or archival of expired or obsolete records.

4.5) Document Retrieval and Retrieval:
4.5.1) Establish procedures for document retrieval to ensure timely access for audits, inspections, or internal reviews.
4.5.2) Maintain an organized document repository with indexing and search capabilities for efficient retrieval.

4.6) Record Keeping Compliance:
4.6.1) Conduct regular audits and reviews of record keeping practices to ensure compliance with regulatory standards and internal policies.
4.6.2) Implement corrective actions as needed to address deficiencies identified during audits.

5) Abbreviations, if any

N/A

6) Documents, if any

• Procurement Documents (e.g., Purchase Orders, Contracts)
• Invoices and Payment Records
• Correspondence with Suppliers
• Record Retention Schedule

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 211.180, ICH Q10
Industry Standards: ISO 13485:2016

8) SOP Version

Version 1.0