Standard Operating Procedure for Documentation Control in Creams Production
1) Purpose
The purpose of this SOP is to establish procedures for managing, controlling, and maintaining documentation related to creams production to ensure accuracy, consistency, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the creation, review, approval, distribution, and storage of documentation in creams production, including batch records, SOPs, validation protocols, and quality control records.
3) Responsibilities
It is the responsibility of the Quality Assurance (QA) department to oversee documentation control processes. All departments involved in creams production are responsible for maintaining accurate and up-to-date documentation.
4) Procedure
4.1 Document Creation and Review
4.1.1 Identify the need for new or revised documents based on process changes, regulatory updates, or quality improvements.
4.1.2 Assign a document number, title, and version number to each document.
4.1.3 Draft the document using the standard template, ensuring clarity, accuracy, and completeness.
4.1.4 Review the draft document internally for accuracy, relevance, and compliance with regulatory requirements.
4.1.5 Submit the document for review and approval by relevant department heads and QA.
4.2 Document Approval and Distribution
4.2.1 Obtain formal approval for the document from designated approvers, including QA.
4.2.2 Record the approval date and ensure the document is signed by all approvers.
4.2.3 Distribute approved documents to relevant departments and personnel, ensuring controlled access to current versions only.
4.2.4 Replace obsolete documents with updated versions and ensure proper disposal of outdated copies.
4.3 Document Control and Storage
4.3.1 Maintain a master list of all controlled documents, including document numbers, titles, version numbers, and approval dates.
4.3.2 Store controlled documents in a secure and accessible location, both physically and electronically.
4.3.3 Implement version control to track changes and ensure that only the latest version of each document is in use.
4.3.4 Protect documents from damage, loss, or unauthorized access through proper handling and storage practices.
4.4 Document Review and Revision
4.4.1 Conduct periodic reviews of controlled documents to ensure continued relevance and compliance with current regulations and practices.
4.4.2 Revise documents as necessary to reflect changes in processes, regulations, or quality standards.
4.4.3 Follow the same review, approval, and distribution procedures for revised documents as for new documents.
4.5 Training and Compliance
4.5.1 Ensure all personnel are trained on the procedures and requirements for documentation control.
4.5.2 Conduct regular audits to verify compliance with documentation control procedures and address any deviations or non-conformances.
5) Abbreviations, if any
QA: Quality Assurance
SOP: Standard Operating Procedure
6) Documents, if any
Document Master List
Document Review and Approval Records
Training Records
Document Control Log
7) Reference, if any
ICH Q10: Pharmaceutical Quality System
US FDA CFR (Code of Federal Regulations) Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0
