Glossary
Quality Control
What is Quality Control in pharmaceutical industry?
Quality control is a systematic process used by businesses to ensure that their products or services consistently meet predefined quality standards and customer expectations. It involves inspecting and testing products and implementing corrective actions to maintain product quality.
What role does Quality Control play in pharma?
Quality Control (QC) plays a crucial role in the pharmaceutical industry by ensuring the quality, safety, and efficacy of drug products. The main functions of QC include:
- Sampling, inspection and testing of raw materials, packaging materials, in-process products and finished products to ensure they meet predefined specifications and quality standards.
- Releasing or rejecting batches for sale based on QC test results
- Maintaining comprehensive records of all QC procedures and investigating any deviations
- Conducting technical audits of the QC laboratory to ensure analytical quality systems are effective and instrumentation is functioning properly
- Investigating market complaints, batch failures, deviations and analysing quality trends
How does Quality Control ensure regulatory compliance in pharma?
Quality Control ensures regulatory compliance through activities like sampling, testing, batch release, deviation investigations, analytical method validation, and maintaining comprehensive quality records. Here are some key takeaways of QC in regulatory compliance:
- Quality Control is responsible for reviewing all test results and documentation to determine if a production batch meets the required standards before it can be released for distribution. This “batch release” process is a key regulatory requirement.
- QC develops, validates, and maintains analytical test methods to ensure they are suitable for their intended use and meet regulatory guidelines. This provides assurance of data integrity.
- QC maintains comprehensive records of all quality control activities, test results, and investigations. These detailed records demonstrate compliance to regulatory bodies during inspections.
