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