QC2 prelims

• Assay


  The process of a quantitative determination of a chemical substance from a given sample
• Qualitative method


  Yields information about the identity of atomic or molecular species or the functional groups in the sample
• Quality Control


  1. Checking or testing that specifications are met (PIC/s cGMP 2018)

  2. Ensures the safety, efficacy, stability, and purity of raw materials and drug products
• Quality Control can be with or without a license
• RA 10918- Philippine Pharmacy Act
• AO 62 Prescribing
• Pharmaceutical Analysis


  Branch of practical chemistry involving identification, determination, quantification, and purification of substances; separation of components of a solution or mixture; determination of the structure of chemical compounds
• Instruments used

  • pH meter
  • Photometer
  • Coulometer
  • Mass Spectrometer
  • Liquid Chromatography
  • Atomic Emission Spectrometer
  • Gas Chromatograph with Flame Ionization
• Quality Control responsibilities


  • Checking
  • Testing
  • Assaying
• RA 6675 The Generics Law 1988
• Quality Assurance


  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 (PIC/s cGMP 2018)
• Quantitative method


  Provides numerical information as to the relative amount of one or more of these compounds
• Analytical Chemistry


  Deals with methods for determining the chemical composition of samples of matter
• AO 63 Dispensing
• Pharmacopeia methods


  • European Pharmacopoeia
  • United States Pharmacopeia (USP)
  • British Pharmacopoeia
  • Japanese Pharmacopoeia
• Quality


  A distinguishing characteristic, property, or attribute; the basic character or nature of something; a trait or feature of personality; degree or standard of excellence, especially a high standard
• Quality Control is a decision-maker
• Chromatography techniques

  • Thin Layer Chromatography (TLC)
  • Liquid-Liquid Chromatography (LLC)
  • Gas Chromatography (GC)
  • Column Chromatography (CC)
  • Ion-Exchange Chromatography (IEC)
  • Molecular Exclusion Chromatography (MEC)
  • High Pressure Liquid Chromatography (HPLC)
  • Electrophoresis
  • Capillary Electrophoresis (CE)
• ISO 9000


  Degree to which a set of inherent characteristics fulfills requirements
• ISO 8402-1986 standard defines quality as the totality of features and characteristics of a product or service that bears its ability to satisfy stated or implied needs
• The quality of a product or service refers to the perception of the degree to which it meets the customer's expectations
• Pharmaceutical Quality System is now referred to as PQS, not TQMS, as it is not focused only on pharmaceutical products
• Quality Control ensures products are consistently produced and controlled to meet quality standards appropriate for their intended use
• Organization of a Typical Quality Assurance Organization

  • Local Industry Scenario
  • Multinational companies
  • Local companies
  • Importers/Traders
  • Other opportunities
• Consumers

  • May focus on the specification quality of a product/service
  • Compare it to competitors in the marketplace
• Quality has no specific meaning unless related to a specific function and/or object. It is a perceptual, conditional, and somewhat subjective attribute
• Producers


  • Measure the conformance quality, or degree to which the product/service was produced correctly
• Quality Assurance


  • Covers all matters influencing the quality of a product
  • Organized arrangements to ensure products meet intended use requirements
• Six Sigma


  Number of defects per million opportunities
• In manufacturing, quality is a measure of excellence or a state of being free from defects, deficiencies, and significant variations
• Pharmaceutical Validation is the action of proving a system or process
• Good Manufacturing Practice (GMP) is concerned with sampling, specifications, testing, organization, documentation, and release procedures to ensure quality
• Organization of a Typical Pharmaceutical Manufacturing Company

  • Incoming materials QA
  • In-process QA
  • Finished products QA
  • Analytical testing
  • Documentation
  • Stability testing
  • cGMP audit
• Validation is performed for new premises, equipment, utilities, systems, processes, and procedures; at periodic intervals; and when major changes have been made
• Validation and qualification are essentially components of the same concept
• Qualification is part of validation
• Assays in USP do not need validation
• Analytical methods should be validated by research and development before being transferred to the quality control unit when appropriate
• Revalidation is the repeated validation of an approved process to ensure continued compliance with established requirements
• Validation Master Plan (VMP) is a high-level document that establishes an umbrella validation plan for the entire project