PHARM ANALYSIS

• The sum of all factors which contribute directly or indirectly to the safety,

  effectiveness, and reliability of the product

  Quality = Productivity = Profitability

  Quality
• Concerned with sampling, specifications, testing, organizations,

  documentation and release procedures

  Quality control
• The overall organizational body designed to assure product quality

  Quality assurance
• A system for ensuring that products are consistently produced and

  controlled according to quality standards

  Good manufacturing practice(GMP)
• Pharmaceutical Inspection Co-operation Scheme

  To remove barriers to trade in medicinal products

  PICS (PIC/S)
• Written statements of particular needs to be satisfied

  Specifications
• 2 types of specifications

  Performance specifications

  Technical specification
• Conform to known customer requirements

  Performance specification
• Express level of performance of individual units

  Technical specification
• General chapter of USP-NF: Below 1000

  monograph and general notices
• General chapter of USP-NF: 1000-1999

  informational purposes
• General chapters of USP-NF: above 2000


  dietary supplements
• Contains article’s name, definition, specification, and requirements

  Monograph
• Definitive textbook and reference on the science and practice of pharmacy

  Remington
• Remington is revised every

  5 years
• International Organization for Standardization

  ISO
• For quality management (what the organization does to ensure products

  are of quality)

  ISO 9001
• For environmental management


  ISO 14001
• 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

  Total quality management
• Quality assurance or control: Makes sure that we are doing the right things, the right way.


  QA
• Quality assurance or control: Makes sure the results of what we have done are what we expected.

  QC
• Quality assurance or control: Focuses on building in quality and hence

  preventing defects.

  QA
• Quality assurance or control: Focuses on testing for quality and hence

  detecting defects.

  QC
• Quality assurance or control: deals with process.

  QA
• Quality assurance or control: Deals with product.

  QC
• Quality assurance or control: For entire life cycle.

  QA
• Quality assurance or control: For testing part in SDLC.

  QC
• Quality assurance or control: Preventive process.

  QA
• Quality assurance or control: Corrective process.

  QC
• Focuses on: raw materials, packaging materials, inventories from

  storage to distribution, perform audit

  Material Inspection Section
• For testing and approving raw materials, work in-process and finished

  product

  Analytical laboratory
• To perform and evaluate microbiological and pharmacological assays,

  sterility, pyrogen and bacteriological tests, irritation, safety or acute

  toxicity tests

  Conduct environmental monitoring

  Biological testing lab
• • Coordinate with research, product development, production, sales

  and management towards improvements of product

  Establish specifications for raw and packaging materials

  • Validate existing and tentative procedures of testing

  Specifications and Analytical Development
• Documentation is its main responsibility

  Quality coordination Office
• Reagents should be


  Pure

  Conform to USP/NF requirements

  AR grade
• High quality chemical for laboratory use


  American Chemical Society
• Suitable for use in analytical chemistry

  Guaranteed Reagent
• Highly purified chemicals


  Analytical Reagent
• Used for standardization of solution to a very high degree of accuracy


  Primary standard
• Limited to inorganic chemicals (no official standards)

  Purified