Standard Operating Procedure for Batch Record Preparation in Vaginal Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to define the procedure for preparing batch records accurately and comprehensively to ensure consistent manufacturing of vaginal dosage forms.

2) Scope

This SOP applies to the preparation of batch records for all batches of vaginal dosage forms manufactured at the facility.

3) Responsibilities

The Production Department is responsible for preparing batch records in accordance with this SOP. The Quality Assurance (QA) Department is responsible for reviewing and approving batch records before manufacturing begins.

4) Procedure

4.1 Batch Record Initiation

1. Retrieve the master batch record template approved by QA for the specific product.
2. Enter batch-specific information such as batch number, date, start time, and equipment identification.

4.2 Materials and Equipment Verification

1. Verify the availability and correctness of raw materials, packaging materials, and equipment to be used in the batch.
2. Document material and equipment verification in the batch record.

4.3 Manufacturing Instructions

1. Follow the approved manufacturing instructions outlined in the master batch record.
2. Record all critical manufacturing parameters including mixing times, temperatures, and any deviations from standard operating procedures.

4.4 In-Process Controls and Sampling

1. Perform in-process controls as specified in the master batch record.
2. Take samples at designated stages of production for quality control testing.

4.5 Packaging Instructions

1. Follow the approved packaging instructions for labeling, batch coding, and packaging of finished vaginal dosage forms.
2. Document packaging details including label reconciliation and packaging line clearance.

4.6 Completion and Review

1. Complete the batch record with all required entries and sign-offs.
2. Submit the completed batch record to QA for review and approval.

5) Abbreviations, if any

QA: Quality Assurance

6) Documents, if any

Master batch record template, equipment log, material reconciliation record

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, WHO Technical Report Series No. 961, Annex 2: WHO guidelines on good manufacturing practices for pharmaceutical products

8) SOP Version

Version 1.0