List Of Qa Documents In Pharmaceutical Industry -
: Evidence that a system or equipment performs effectively and reproducibly based on approved process methods and specifications.
A document completed during production that records the actual data, operator signatures, and timestamps for a specific batch.
These prove that your physical environment won't contaminate or mislabel products.
Below is a categorized by their function within the pharmaceutical lifecycle. Use this as a checklist to ensure your QMS is audit-ready. list of qa documents in pharmaceutical industry
Formal documents that define the detailed requirements (tests, references to analytical procedures, and appropriate acceptance criteria) that a product or material must meet before being deemed acceptable. This includes specifications for raw materials, packaging materials, intermediates, and finished products.
: Verification and evidence that equipment or systems are installed according to manufacturer specifications and engineering drawings.
A strategic document outlining which facilities, equipment, utilities, processes, and software must be validated, including timelines and responsibilities. 2. Standard Operating Procedures (SOPs) : Evidence that a system or equipment performs
: A yearly analysis of all batches to verify process consistency and identify improvement areas. Self-Inspection / Internal Audit Reports
The executed version of the MPCR, filled out in real-time by operators during the manufacturing of a specific batch.
These materials manage external risks from suppliers, service providers, and transport networks. Below is a categorized by their function within
These technical dossiers prove that equipment, systems, processes, and methods consistently yield the desired quality outcomes.
SOPs are detailed, written instructions designed to ensure that specific functions are performed consistently every time. Key QA-specific SOPs include:
: A real-time record used during production to document every step, including raw materials used and operator signatures. Batch Packaging Record (BPR)
