Quality control (QC) Flashcards
What types of evaluations or tests are involved in the analysis of pharmaceutical products?
Chemical, physical, and sometimes microbiological evaluations or tests.
What is the regulatory authority for pharmaceuticals in Uganda?
National Drug Authority.
What is the regulatory authority for pharmaceuticals in South Africa?
Medicines Control Council (MCC).
What is the regulatory authority for pharmaceuticals in Rwanda?
Ministry of Health.
What is the regulatory authority for pharmaceuticals in India?
Central Drug Standards Control Organization (CDSCO).
What is the regulatory authority for pharmaceuticals in Japan?
Ministry of Health, Labour and Welfare (MHLW).
What is the focus of Quality Control (QC)?
It is product-oriented and focuses on defect identification.
What is the difference between Quality Control (QC) and Quality Assurance (QA)?
QC: Focuses on testing and identifying defects in the final product.
QA: Focuses on preventing defects by improving processes and systems.
What are some common QC tests for pharmaceutical tablets?
Weight variation
Hardness
Friability
Dissolution
Assay of active ingredients
What aspects of starting materials (raw materials) are checked by QC?
Identity (e.g., IR, NMR)
Purity (e.g., HPLC, titrations)
Physical properties (e.g., particle size, solubility)
What techniques are used to test active pharmaceutical ingredients (APIs)?
Infrared Spectroscopy (IR)
Nuclear Magnetic Resonance (NMR)
High-Performance Liquid Chromatography (HPLC)
Titrations
What are some common tests for packaging materials?
Appearance (visual inspection)
Spectroscopy (e.g., UV-Vis)
Loss on drying (moisture content)
Why is it important to store reference samples of starting materials and finished products?
To allow for future testing, comparison, and investigation if quality issues arise.
What is the first activity in Quality Control (QC)?
Sampling – Collecting representative samples of materials and products for testing.
What is included in laboratory operations in QC?
Conducting tests, maintaining equipment, ensuring proper documentation, and following Good Laboratory Practices (GLP).
What are the key activities of QC in pharmaceutical manufacturing?
Sampling, specification, testing, release procedures, recalls and complaints, decision-making, defining product quality, laboratory operations, release authorization, and investigation and reporting.
What are the 4 main responsibilities of Quality Control (QC) in the pharmaceutical industry?
Efficacy
Safety
Quality
Compliance
