Producer quality assurance programs

J Kla1, L Tollefson

  • 1Center for Veterinary Medicine, US Food and Drug Administration, Rockville, MD 20855, USA.

Related Concept Videos

Proofreading01:43

Proofreading

Synthesis of new DNA molecules starts when DNA polymerase links nucleotides together in a sequence that is complementary to the template DNA strand. DNA polymerase has a higher affinity for the correct base to ensure fidelity in DNA replication. The DNA polymerase furthermore proofreads during replication, using an exonuclease domain that cuts off incorrect nucleotides from the nascent DNA strand.Errors during Replication Are Corrected by the DNA Polymerase EnzymeGenomic DNA is synthesized in...
Quality Assurance01:19

Quality Assurance

Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
Testing Water Quality01:14

Testing Water Quality

When the quality of water for concrete preparation is uncertain, its impact on the setting time of cement and compressive strength of mortar is assessed by comparison with de-ionized or distilled water benchmarks. American Society for Testing and Materials (ASTM) C1602 requires the setting times to be within 90 minutes of the control, British Standard (BS) 3146:1980 allows a 30-minute variance in the initial setting, while British Standards European Norm (BS EN) 1008 specifies initial setting...
Good Manufacturing Practices01:26

Good Manufacturing Practices

Good Manufacturing Practices (GMP) constitute a foundational set of guidelines that ensure the production of safe, consistent, and high-quality products, particularly in industries such as pharmaceuticals, biotechnology, and food processing. These protocols encompass all aspects of production, from the sourcing of raw materials to the final distribution of the finished product.A core pillar of GMP is stringent hygiene and sanitation across all production environments. This includes routine...
Hazard Analysis and Critical Control Points (HACCP)01:30

Hazard Analysis and Critical Control Points (HACCP)

Hazard Analysis and Critical Control Points (HACCP) is a science-based, preventive system used globally to ensure food safety by identifying, evaluating, and controlling biological, chemical, and physical hazards throughout food production. Originally developed by NASA and the Pillsbury Company for astronaut food, HACCP is now a core component of the Codex Alimentarius.HACCP operates on prerequisite programs—such as Good Manufacturing Practices (GMPs), sanitation procedures, and supplier...
Bioreactor Controls-I01:28

Bioreactor Controls-I

Maintaining optimal conditions within fermenters is essential for maximizing microbial productivity and ensuring process efficiency. This lesson focuses on key parameters—temperature, foam, pH, carbon dioxide, oxygen, and pressure—and their precise measurement and control strategies in fermentation systems.Temperature ControlTemperature regulation is critical due to the exothermic nature of many fermentation processes. In small laboratory fermenters, temperature is commonly monitored using...