Standard Operating Procedure for Master Manufacturing Records (MMR) Preparation in Ointment Formulation

1) Purpose

The purpose of this SOP is to define the procedures for preparing Master Manufacturing Records (MMRs) for ointment formulation, ensuring consistency, accuracy, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the preparation, review, and approval of MMRs for ointment formulation. It covers the creation, review, and maintenance of MMRs.

3) Responsibilities

– Production Staff: Responsible for providing input on the manufacturing process for MMR preparation.
– Quality Assurance (QA): Responsible for reviewing and approving MMRs, ensuring compliance with regulatory standards.
– Document Control: Responsible for maintaining and distributing approved MMRs.

4) Procedure

1. Preparation of MMR:
1.1 Template Creation:
1.1.1 Use the approved MMR template for each ointment product.
1.1.2 Ensure the template includes sections for raw materials, equipment, process steps, and quality control measures.
1.2 Data Collection:
1.2.1 Gather information on raw materials, including specifications, quantities, and sources.
1.2.2 Document the manufacturing process, including equipment, procedures, and in-process controls.

1.3 Drafting the MMR:
1.3.1 Complete the MMR template with the collected data.
1.3.2 Include detailed instructions for each manufacturing step to ensure consistency.

Review and Approval of MMR:
2.1 Initial Review:
2.1.1 Conduct an initial review of the MMR for completeness and accuracy.
2.1.2 Address any discrepancies or missing information.

2.2 QA Review:
2.2.1 QA reviews the MMR to ensure compliance with SOPs and regulatory requirements.
2.2.2 Approve or request revisions to the MMR based on the review.

Maintenance and Distribution of MMR:
3.1 Document Control:
3.1.1 Store approved MMRs in a secure, controlled environment.
3.1.2 Ensure MMRs are readily accessible to authorized personnel.

3.2 Updating MMRs:
3.2.1 Review and update MMRs periodically to reflect any changes in the manufacturing process or regulatory requirements.
3.2.2 Document and approve all updates according to the change control procedure.

5) Abbreviations, if any

– MMR: Master Manufacturing Record
– QA: Quality Assurance
– SOP: Standard Operating Procedure

6) Documents, if any

– MMR Templates
– Approved MMRs
– Review and Approval Logs

7) Reference, if any

– FDA Current Good Manufacturing Practice (CGMP) Regulations
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0