Standard Operating Procedure for Batch Manufacturing Record for Transdermal Patches

1) Purpose

The purpose of this SOP is to establish guidelines for documenting and maintaining accurate batch manufacturing records (BMR) for transdermal patches throughout the production process.

2) Scope

This SOP applies to the creation, completion, and review of BMRs for each batch of transdermal patches manufactured within the facility.

3) Responsibilities

The Production Department is responsible for executing and maintaining BMRs as per this SOP. Quality Assurance (QA) personnel are responsible for reviewing and approving BMRs.

4) Procedure

4.1 BMR Preparation

• 4.1.1 Initiate the BMR at the start of batch production, including recording batch number, date, and product identification details.
• 4.1.2 Verify that all materials, equipment, and personnel involved in the batch are documented as per standard operating procedures (SOPs).

4.2 Manufacturing Steps

• 4.2.1 Document step-by-step procedures for each manufacturing process, including formulation, mixing, coating, and drying, as applicable.
• 4.2.2 Record critical process parameters (e.g., temperature, pressure, time) and any deviations observed during manufacturing.

4.3 In-Process Controls

• 4.3.1 Perform in-process testing and sampling as specified in approved procedures to verify product quality and compliance with specifications.
• 4.3.2 Document results of in-process checks, including measurements, observations, and any adjustments made during production.

4.4 Packaging and Labeling

• 4.4.1 Detail packaging and labeling procedures in the BMR, ensuring alignment with approved packaging specifications.
• 4.4.2 Record packaging line parameters and verify reconciliation of packaged units against planned quantities.

4.5 Batch Yield and Reconciliation

• 4.5.1 Calculate batch yield based on actual production output and reconcile with planned production quantities documented in BMR.
• 4.5.2 Investigate and document any discrepancies found during yield calculation or reconciliation.

4.6 Final Approval and Release

• 4.6.1 Review completed BMR for accuracy, completeness, and compliance with regulatory requirements and internal standards.
• 4.6.2 Obtain approval from authorized personnel, including QA, for final batch release based on review of BMR and associated documentation.

5) Abbreviations, if any

SOP: Standard Operating Procedure
BMR: Batch Manufacturing Record
QA: Quality Assurance

6) Documents, if any

Approved Master Batch Record
In-Process Testing Procedures
Packaging Specifications

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
ISO 14644: Cleanrooms and associated controlled environments

8) SOP Version

Version 1.0