To help narrow down or expand this structure for your specific project, tell me:
(VMP, Site Master File, Quality Agreements)
These documents provide a chronological history of how a specific batch was made.
SOPs provide step-by-step instructions to ensure routine operations are performed consistently and safely across the organization. list of qa documents in pharmaceutical industry
: Protocols proving that cleaning procedures effectively remove drug residues, detergents, and microbes below safe limits.
Before any equipment, facility, utilities, or processes can be used, they must be rigorously tested and documented.
Guidelines for conducting self-inspections to ensure the QMS remains effective. 3. Production and Manufacturing Records To help narrow down or expand this structure
id: "DOC-000123", title: "SOP: Cleanroom Entry", category: "SOP", subcategory: "Facility", version: "3.1", status: "Approved", effectiveDate: "2025-10-01", owner: id: "u-45", name: "QA Manager" , approver: id: "u-12", name: "Head of QA" , products: ["DrugA", "DrugB"], relatedDocuments: ["DOC-000110","DOC-000200"], retentionPeriodYears: 15, regulatoryTags: ["GMP","21CFR11"], checksum: "sha256:abcd...", reviewFrequencyMonths: 12, nextReviewDate: "2026-10-01"
: Verification and evidence that equipment or systems are installed according to manufacturer specifications and engineering drawings.
A formal system by which qualified representatives review proposed or actual changes that might affect the validated status of facilities, systems, equipment, or processes. Before any equipment, facility, utilities, or processes can
: A formal system used to propose, evaluate, review, and approve changes to validated systems, processes, documents, or equipment before implementation.
Detailed requirements for raw materials, intermediates, packaging materials, and finished products.
The high-level document defining the company's quality policy, objectives, and scope of the QMS.