Quality Control & Testing (QC) — Overview¶
Quality Control (QC) is the set of tests and checks that give you objective evidence that your raw materials and finished products meet their specifications before they reach customers. No batch should be released without passing QC.
What this section covers¶
- Specifications — writing acceptance criteria for raw materials, packaging, and finished products
- Raw material testing and approval before use
- In-process testing during manufacture
- Finished product testing and certificate of analysis (CoA)
- Retain samples — keeping reference samples for each batch
- Out-of-specification (OOS) results — investigation and decision process
- Laboratory controls — reference standards, reagents, and instruments
- Contract testing laboratories — selecting and qualifying external labs
- Stability testing — proving shelf-life claims
- Batch release decision — the formal sign-off process