Analytical Chemistry & Pharmaceutical Analysis

allelipraise's version from 2018-02-03 01:28

Section 1

Question Answer
Pharmaceutical analysisis a branch of practical chemistry that involves a series of processes
Pharmaceutical analysisinvolves analyses of raw materials, active pharmaceutical ingredients (API's), intermediates, excipients, pharmaceutical substances and finished products.
Pharmacopeia methodsperformed according to the European Pharmacopoeia, the United States Pharmacopeia (USP), the British Pharmacopoeia, and the Japanese Pharmacopoeia among others.
Qualityas applied to a drug product
Qualityhe sum of all factors which contribute directly or indirectly to the safety, effectiveness, and reliability of a product
Quality (US FDA Guidelines for Industry)a measure of a product’s or service’s ability to satisfy the customer’s stated or implied needs
Quality (ICH Q10 Guideline)the degree to which a set of inherent properties of a product, system or process fulfills requirements
Quality Controlguarantees within reasonable limits that a drug product
Assayinga quantitative analysis performed to establish the proportion of the essential component
Qualitative analysisestablishes the chemical identity of the species in a sample
Quantitative analysisdetermines the relative amounts of these species (analytes) in numerical terms
Analytesare components of a sample that are to be determined
Branches of Analytical ChemistryCharacterization/ Fundamental analysis
Characterization analysisan analysis in which we evaluate a sample’s chemical or physical properties.
Fundamental analysisan analysis whose purpose is to improve an analytical method’s capabilities.

Section 2

Question Answer
Qualityshould be the responsibility of all persons involved in manufacturing.
Quality Assurance (QA)the sum total of the organized arrangements made with the object of ensuring that all APIs are of the quality required for their intended use and that quality systems are maintained.
Quality Control (QC)checking or testing that specifications are met, ensuring purity, stability, identity, potency, and bioavailability of the drug
Acceptance criteria numerical limits or ranges, or other suitable measures for acceptance of test results
All quality-related activitiesshould be defined and documented, specifically, recorded at the time they are performed.
Quality Unit (QU)a unit independent of production that fulfills both quality assurance (QA) and quality control (QC)
Product Quality Reviewconducted with the objective of verifying the consistency of the process

Section 3

Question Answer
Quality AssuranceEnsuring that the quality policies adopted by a company are followed
Quality AssurancePrepare SOPs relative to the control of quality
Quality AssuranceFinal authority for product acceptance or rejection
Quality AssuranceQuality monitoring and audit
Quality ControlTesting and measuring material and product
Quality Control Environmental monitoring (e.g., HVAC)
Quality ControlInspecting operations for compliance