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, ensuring appropriate expertise and authority.
• 4.3.2 Maintain records of document reviews, approvals, and rejections, including reasons for changes or rejections.

4.4 Document Distribution

• 4.4.1 Distribute controlled documents only to authorized personnel with documented training on document use and handling.
• 4.4.2 Ensure that obsolete documents are promptly removed from use and archived according to document retention policies.

4.5 Document Retrieval and Storage

• 4.5.1 Store documents in secure, organized, and accessible locations to prevent loss, damage, or unauthorized access.
• 4.5.2 Establish procedures for document retrieval, ensuring that documents are readily available for inspection, review, and audits.

4.6 Document Retention

• 4.6.1 Maintain records of document retention periods based on regulatory requirements and internal policies.
• 4.6.2 Archive documents securely after their retention period expires, maintaining traceability and accessibility as needed.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance

6) Documents, if any

Master List of Controlled Documents
Document Change Control Records

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes

8) SOP Version

Version 1.0