Lecture 7 Flashcards
What is the difference between Quality Assurance (QA) and Quality Control (QC) in pharmaceuticals?
QA is a proactive system of management procedures aimed at preventing defects through process design. QC is a reactive system of technical procedures that identifies defects after they occur.
What defines a drug of “good quality”?
Pharmacopoeia standards define good quality, focusing on identity, purity, and stability, regulated by authorities
What does QC testing involve in the pharmaceutical industry?
QC testing involves various analytical techniques and microbiological testing to ensure that the final product meets pharmacopoeia standards for quality, purity, and safety.
Why is water quality important in pharmaceuticals?
Water is used in various stages, from R&D to manufacturing and QC, making its quality crucial. The required quality level depends on the process stage and must comply with GMP standards.
Why are QC tests important for parenteral products?
QC tests ensure the safety, sterility, and efficacy of parenteral products, including tests for sterility, stability, and pH
What are common methods for sterilizing parenteral products?
Sterilization methods for parenterals include heat, gas, radiation, and filtration to ensure sterility and safety.
Why are excipients in parenteral formulations carefully chosen?
Excipients must be carefully selected to ensure they do not adversely affect the API or cause harmful side effects in the final parenteral product.
What are the requirements for containers used for parenteral products?
Containers must be made of transparent materials to allow for visual inspection and detection of particles
Why is pyrogen testing important in parenteral products?
Pyrogens can cause harmful reactions, so parenteral products must be tested to ensure they are free of these contaminants.
What do disintegration and dissolution tests evaluate in tablets?
These tests assess the tablet’s ability to break down and release the active pharmaceutical ingredient (API) for proper absorption in the body.
