Standard Operating Procedure for Documentation in Transdermal Patches Production

1) Purpose

The purpose of this SOP is to define the procedures for documentation practices in the production of transdermal patches to ensure traceability, compliance with regulatory requirements, and effective record-keeping.

2) Scope

This SOP applies to all documentation generated and maintained during the production, testing, packaging, and distribution of transdermal patches within the facility.

3) Responsibilities

The Quality Assurance (QA) Department is responsible for establishing and maintaining documentation procedures outlined in this SOP. Production personnel are responsible for accurately documenting activities in accordance with these procedures.

4) Procedure

4.1 Document Control

• 4.1.1 Maintain a master list of all controlled documents related to transdermal patch production, including SOPs, batch records, specifications, and forms.
• 4.1.2 Assign unique document identifiers (e.g., document number, version number, revision date) for easy identification and tracking.
• 4.1.3 Implement a document change control procedure to manage revisions, approvals, and distribution of updated documents.

4.2 Document Preparation

• 4.2.1 Prepare documents using clear and concise language, ensuring accuracy, completeness, and alignment with current procedures and specifications.
• 4.2.2 Include required information such as batch numbers, dates, signatures, and any other relevant data as per document requirements.

4.3 Document Review and Approval

• 4.3.1 Submit documents for review and approval to designated personnel,