Standard Operating Procedure for Documentation in Creams Production
1) Purpose
The purpose of this SOP is to establish guidelines for the documentation practices in creams production within a pharmaceutical manufacturing facility to ensure accuracy, traceability, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in creams production, including production, quality control (QC), quality assurance (QA), and regulatory affairs. It covers procedures for document creation, review, approval, distribution, and retention.
3) Responsibilities
It is the responsibility of the production supervisor, QC/QA teams, and regulatory affairs personnel to follow this SOP. The production supervisor ensures that production records are accurately documented, while QC/QA teams review and approve documents to verify compliance. Regulatory affairs personnel ensure that documentation meets regulatory standards.
4) Procedure
4.1 Document Creation
4.1.1 Prepare documents (e.g., batch records, SOPs, forms) using approved templates and formats.
4.1.2 Include all required information such as batch number, product name, manufacturing dates, and signatures of personnel involved.
4.1.3 Ensure documents are legible, clear, and free from errors.
4.2 Document Review and Approval
4.2.1 Submit documents for review to designated QC/QA personnel according to the document review and approval workflow.
4.2.2 Reviewers verify completeness, accuracy, and compliance with procedures and regulatory requirements.
4.2.3 Approve documents with appropriate signatures and dates once review is completed satisfactorily.
4.3 Document Distribution
4.3.1 Distribute approved documents to relevant personnel or departments, ensuring controlled distribution lists are maintained.
4.3.2 Implement document control measures to prevent unauthorized access, use, or distribution of documents.
4.3.3 Retrieve obsolete documents and replace them with current versions as per document control procedures.
4.4 Document Retention
4.4.1 Establish document retention periods based on regulatory requirements and company policies.
4.4.2 Archive documents in a secure location with proper indexing and labeling for easy retrieval during inspections or audits.
4.4.3 Dispose of expired or obsolete documents according to document retention and disposal policies.
4.5 Document Amendments and Change Control
4.5.1 Initiate document amendments when necessary due to process changes, regulatory updates, or quality improvements.
4.5.2 Follow change control procedures for documenting, reviewing, approving, and implementing document changes.
4.5.3 Communicate document changes to affected personnel and provide training as needed.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
SOP: Standard Operating Procedure
6) Documents, if any
Batch Records
SOPs (Standard Operating Procedures)
Forms and Templates
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
EU GMP Annex 15: Qualification and Validation
8) SOP Version
Version 1.0
