Qc prelims

• Quality


  • Totality features or conformance to specifications of a product
  • Ensures that products are fit for their intended use, safe, and compliant with the requirements of the marketing authorization
• Total Quality Management (TQM)


  A combined team effort to develop, produce, market, distribute, and control products that are safe and will be effective for the time they remain in the marketplace
• Quality Assurance (QA)


  • Totality of the organized arrangements made with the objective of ensuring that products are of the quality required for their intended use
  • Wide ranging concept that covers all matters individually or collectively influence
• Current Good Manufacturing Practice (CGMP)

  Part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate for their intended use
• Quality Control


  Part of CGMP concerned with sampling, specifications, testing, organization, documentation and release procedures
• Product Quality Review (PQR)


  Regular periodic quality reviews of all registered drug products to verify consistency of the existing process and to identify product and process improvements
• Quality risk Management (QRM)


  A systematic process for the assessment, control, communication, and review of risks to the quality of the product
• Quality Unit


  • An organizational unit independent of Production which fulfills both Quality Assurance and Quality Control responsibilities
  • QA Unit ensures the quality policies are followed, audits and monitors, is the primary contact with regulatory agencies, and prepares SOPs
  • QC Unit conducts sampling and testing of RM & FP, inspects PM components, and performs environmental monitoring
• Monograph


  Specifies all the tests to be conducted on a material and the expected results
• Standard Operating Procedure (SOP)


  Step-by-step instruction for doing a particular task or activity
• Certificate of Analysis (COA)

  Shows the actual result of all tests conducted on a material to show compliance with standards
• Material Safety Data Sheet (MSDS)


  Contains information on the potential health effects of exposure to chemicals and on safe working procedures when handling chemical products
• Sampling


  The process of removal of an appropriate number of items (n) from a population (N)
• Sampling Plan


  • MIL-STD-105E (Military Standard) – most common (old); master tables
  • ANSI/ ASQ Z1.4-2008 – most common (new)
  • Square Root System – easier (use in exam) n= √N + 1
• Control Charts


  Graphs on which the quality of the product is plotted as manufacturing is actually proceeding
• Types of Control Charts

  • p-Chart – proportion of defectives
  • np-Chart – non-proportion (number of defectives)
  • X Bar Chart – used for measurable characteristics
• Warning limit


  Alerts the operator to closely monitor the process
• Action limit


  Alerts the operator to stop the process and do corrective action
• Validation


  The action of proving and documenting that any process, procedure or method actually leads to the expected results
• Qualification


  The action of proving that premises, systems or equipment work correctly and actually lead to expected results
• Classification of Product Defects by Magnitude

  • Critical Defect – may endanger life of patient
  • Major Defect – does not endanger life of patient but affects the function of the product
  • Minor Defect – does not endanger life of patient and does not affect the function of the product
• Classification of Product Defects by Measurability

  • Variable Defect – measured by an instrument
  • Attributive Defect – measured by inspection
• Classification of Product Defects by Nature

  • Ocular Defect – can be seen by the naked eye
  • Internal Defect – cannot be seen by the naked eye
• Classification of Product Recall

  • Class I Recall – may cause death or serious adverse health consequences
  • Class II Recall – may cause temporary/ medically reversible adverse health consequences
  • Class III Recall – not likely to cause adverse health consequences
• Stability


  Capacity of a drug to remain within specification
• Minimum Acceptable Potency: 90%
• Drug products are mainly decomposed by

  • Hydrolysis
  • Oxidation
  • Photolysis
• Shelf-life (t90)


  Period of time during which a product is expected to remain within specification
• Expiration Date


  Time or date prior to which a product is expected to remain stable and after which it must not be used
• Calculating Expiration Date


  Expiration Date = Manufacturing Date + Shelf-life
• Climatic Zones


  • Zone I (Temperate) - 21 ± 2°C, 45 ± 5% humidity
  • Zone II (Mediterranean/Subtropical) - 25 ± 2°C, 60 ± 5% humidity
  • Zone III (Hot and dry) - 30 ± 2°C, 35 ± 5% humidity
  • Zone IVA (Hot and humid) - 30 ± 2°C, 65 ± 5% humidity
  • Zone IVB (Hot and very humid) - 30 ± 2°C, 75 ± 5% humidity
• Types of Stability Studies

  • Long-term Studies
  • Accelerated Studies
  • Stress Testing
• Quarantine


  Status of materials which are isolated physically while a decision is awaited on their release, rejection or reprocessing
• Warehouse Distribution Practices


  • First in-First out (FIFO)
  • First expiry-first out (FEFO)
• Identification Test Methods


  • Chemical Methods - color reactions, precipitation, evolution of gas
  • Instrumental Methods - spectroscopy, chromatography
• Assay Methods


  • Chemical Assay - titrimetry, instrumental methods
  • Biologic Assay - animal assay, microbial assay
• Animals Used in Drug Assays

  • Digitalis - Pigeon
  • Tubocurarine - Rabbit
  • Insulin - Rabbit
  • Glucagon - Cat
  • Corticoprin - Rat
  • Cod Liver Oil - Rachitic Rat
• Microbiological Assay Methods


  • Cylinder Plate Method
  • Turbidimetric Method
• Test Organisms for Antibiotic Assays

  • Penicillin G - Staphylococcus aureus
  • Bacitracin - Micrococcus luteus
  • Streptomycin - Klebsiella pneumoniae
  • Chloramphenicol - Escherichia coli
  • Vancomycin - Bacillus subtilis
• Test Organisms for Vitamin Assays

  • Niacin, Ca Pantothenate - Lactobacillus plantarum
  • Cyanocobalamin - Lactobacillus leichmanii