Standard Operating Procedure for Annual Product Review in Transdermal Patches Production

1) Purpose

The purpose of this SOP is to establish procedures for conducting annual product reviews (APRs) of transdermal patches to evaluate product quality, performance, and compliance with regulatory requirements.

2) Scope

This SOP applies to the annual review of all transdermal patch products manufactured within the facility.

3) Responsibilities

The Quality Assurance (QA) Department is responsible for conducting APRs as per this SOP. Production and Quality Control personnel provide necessary data and documentation for review.

4) Procedure

4.1 Data Collection and Compilation

• 4.1.1 Gather relevant data and documentation from batch records, in-process testing results, stability studies, complaints, and deviations.
• 4.1.2 Compile comprehensive data sets for each product batch, ensuring inclusion of critical quality attributes and performance indicators.

4.2 Review of Product Quality

• 4.2.1 Evaluate product quality attributes, including but not limited to appearance, physical properties, drug content uniformity, and adherence to specifications.
• 4.2.2 Compare APR findings with established acceptance criteria and specifications outlined in approved master batch records (MBRs) and regulatory guidelines.

4.3 Performance Analysis

• 4.3.1 Assess product performance based on stability data, shelf-life studies, and customer feedback to ensure consistency and efficacy throughout the product lifecycle.
• 4.3.2 Identify trends or deviations in performance parameters and