Quality Assurance and Control Flashcards
Define manufacturing quality.
Strict adherence to measurable and verifiable standards to achieve uniformity of outputs that satisfies user requirements
Define quality assurance.
Quality management aimed at preventing defects in products and throughout the manufacturing process
What are the acceptance criteria for quality control?
API content within 10% of target
API content 90-100% post stability testing
What are the documentation requirements for each batch of product?
Batch number Date of receipt Name/address of testing lab Name/address of original manufacturer and person requesting tests Name/description of batch Reference to specification used in testing Signature of authority Expiry/retest date
What is good manufacturing practice?
Ensures products are consistently produced and controlled based on the ‘Orange Guide’ protocol
What is good laboratory practice?
Standards to regulate toxicological studies, identity, purity, stability and storage
What is good clinical practice?
Fundamental to designing and performing clinical trials
Define ISO quality.
Ability to satisfy state or implied needs set out by regulatory body
Define pharmaceutical quality.
Procedures undertaken to ensure identity and purity of a particular pharmaceutical
What are counterfeit medicines?
Fake medicines that may be contaminated or contain the wrong/no API.
They are generally manufactured under poor standards of GMP compliance
What is the detection limit?
The lowest amount that can be detected
What is the quantification limit?
The largest amount that can be detected
What is linearity?
The ability to obtain data directly proportional to the concentration of the analyte§
What do control charts show?
Whether a sample can be classified within the required range of variation
