Standard Operating Procedure for Documentation in Lotions Production

1) Purpose

The purpose of this SOP is to define the procedures for accurate and comprehensive documentation practices throughout the lotions production process to ensure traceability, compliance, and quality assurance.

2) Scope

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

3) Responsibilities

The responsibilities for executing this SOP are as follows:

Production Personnel:

• Record production activities, observations, and deviations accurately and in real-time.
• Ensure all documentation is complete, legible, and conforms to established formats.

Quality Assurance (QA) Personnel:

• Review and approve production documentation for completeness and accuracy.
• Verify compliance with regulatory requirements and internal standards.

Documentation Control Officer:

• Manage document control processes, including issuance, revision, and archival of documents.
• Ensure controlled copies of documents are available to authorized personnel.

4) Procedure

4.1 Document Preparation:

• Use approved document templates and forms for recording production activities, including batch records, log sheets, and protocols.
• Include all necessary information such as batch numbers, dates, signatures, and any required approvals.

4.2 Real-Time Documentation:

• Record production activities promptly and accurately during each stage of the lotions manufacturing process.
• Document critical process parameters, equipment settings, and environmental conditions as applicable.

4.3 Review and Approval:

• Submit completed documents for review and approval according to defined procedures and timelines.
• Ensure QA review includes verification of data integrity, compliance with SOPs, and resolution of any discrepancies.

4.4 Document Distribution and Control:

• Distribute controlled copies of approved documents to authorized personnel.
• Maintain document revision history and ensure obsolete documents are removed from circulation.

4.5 Archival and Retention:

• Archive completed batch records and other critical documents in accordance with retention policies and regulatory requirements.
• Ensure documents are readily retrievable for audits, inspections, and internal reviews.

5) Abbreviations, if any

SOP: Standard Operating Procedure

QA: Quality Assurance

GMP: Good Manufacturing Practice

6) Documents, if any

• Batch Records
• Log Sheets
• Protocol Forms

7) Reference, if any

• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals

8) SOP Version

Version 1.0