(Quality Manual, Quality Policies)
Use this list to perform a gap analysis of your current QMS. If you are missing more than 20% of these, it might be time for a documentation remediation project.
: Formal documentation of any unplanned departure from an approved SOP, specification, or master record during operations.
| Document Type | Description | |---------------|-------------| | | A high-level document outlining the company’s quality policy, objectives, and scope of the Quality Management System (QMS). | | Quality Policy | A statement of intent from executive management regarding commitment to quality and compliance. | | Quality Plan | A document specifying procedures, resources, and activities to achieve quality objectives for a specific product or project. | | Site Master File (SMF) | A document describing the pharmaceutical manufacturer’s production site, facilities, equipment, and quality system (required for regulatory inspections). | list of qa documents in pharmaceutical industry
Pharmaceutical QA documents are not created equal. They follow a structured hierarchy, often visualized as a "QMS documentation pyramid," which clarifies the relationship between documents, from the broadest to the most specific. Understanding this structure is key to building an effective Pharmaceutical Quality System (PQS).
This blog post provides a comprehensive list of the essential QA documents required for Good Manufacturing Practice (GMP) compliance in the pharmaceutical industry.
, ranging from high-level management policies to real-time records of production. 1. Apex/Governance Documents (Level 1) (Quality Manual, Quality Policies) Use this list to
QA documents play a critical role in ensuring compliance with regulatory requirements and maintaining the quality of pharmaceutical products. The following are some of the reasons why QA documents are essential:
Supplier Quality Agreements and Qualification Records
: Similar to the BMR, specifically for the packaging and labeling phases. 4. Validation & Qualification Documentation | | Site Master File (SMF) | A
This category captures the processes for managing problems and driving continuous improvement.
A detailed description of how the system or equipment will function to meet the URS.
Proof that your people are competent.