Evidence that the manufacturing process reliably produces a product meeting its predetermined specifications.
The supreme document outlining the company’s quality policy, commitment, and QMS structure.
These prove that systems and processes consistently produce expected results. list of qa documents in pharmaceutical industry
What is the of your product (e.g., sterile injectables, oral solids, topicals)?
A formal document signed by QA/QC certifying that a specific batch of product meets its specifications. Evidence that the manufacturing process reliably produces a
These ensure that raw materials and finished products meet strict specifications. 12.2: QA/QC Documentation- SOPs, Batch Records, and COAs
: Defining how personnel are trained and assessed for competency. Vendor/Supplier Qualification : Criteria for assessing and approving external suppliers. 3. Production & Manufacturing Records What is the of your product (e
(Quality Manual, Quality Policies)
Documentation showing that the equipment operates as intended across all anticipated operating ranges.
The actual execution document filled out during production to record real-time data, weights, and times.