analysis 3

• Standards and Specifications - Are developed to serve as a basis for accepting or rejecting a product.
• Formula – a concise and precise statement of the ingredients that comprise the product together with the percentage or weight of each.
• Raw material specification - enumerates the characteristics of all the materials that go into the product and the permissible range of purity of each ingredient. Deviation may cause failure of the product to function as planned, w/c results in undesirable lack of uniformity.
• Standard operating procedure – a step by step method on how to go about a job.
• Finished product specification – cover all characteristics that affect the proper performance, purity, safety and stability of the product. (tolerances may be minimum, maximum or both)
• Packaging material standard – sets for everything that goes around the product. e.g. bottles, cans, etc
• Following to be considered in packaging:

  • The units may have to run on a high-speed line
  • They may involve a complicated assembly
  • The package may be functional
  • The package must be completely compatible with the product.
  • the package must protect and assure its stability.
  • The package must ship well.
• Testing methods - must be standardized to yield results of comparable precision and accuracy.
• Defects - an undesirable characteristic of a product, defined as a failure to conform to specifications.
• Defective – a unit of a product w/c contains one or more defects.
• Quality Variation may occur due to any mistake during the whole process i.e. from the reception of raw material up to the final product in the packaged form.
• Defects can be classified according to measurability, seriousness or gravity and nature
• Variable defect – a defect which can be measured directly by instruments giving dimensions of length, weight, height, thickness, concentration, volume, viscosity, pH or size of particles.
• Attribute defect – a defect w/c cannot be measured directly by instruments. E.g. the number of failures in a production run, paint scratches, discolorations
• Critical defect – a defect w/c may endanger life or property and may render the product non-functional. (e.g. absence of warning in a label for potent drug is considered a critical defect).
• Major defect – a defect w/c may affect the function of the object and therefore may render the product useless. The presence of a crack in a bottle is a major defect.
• Minor defect – a defect w/c does not endanger life or property nor will it affect the function but nevertheless remains a defect since it is outside the prescribed limits.
• Ocular defect – a defect that is visible
• Internal defect – a defect w/c is not seen although present
• Performance defect – a defect in function, e.g., suppository that does not melt at body temperature.
• The risk of errors increases as the number of materials used in the formulation becomes larger, and the manufacturing processes become more complex.
• To minimize and eliminate the sources of variation which can cause product quality variation, approaches such as material control, good manufacturing practice, packaging control, automation and statistical sampling plans are employed.
• Material Inspection Section - Inspectors are alert individuals who had experience and who are familiar with the physical characteristics of the materials they sample and are well versed in sampling techniques.
• Material Inspection Section - To sample and examine all raw materials received.
• Material Inspection Section - To sample and conduct physical test on: a.) All shipments of packaging materials; b.) All manufacturing, filling and packaging operations
• Material Inspection Section - To maintain periodic examination on the quality of inventories throughout all phases of storage, shipping and distribution.
• Material Inspection Section - To perform an audit which is independent of the work done by production personnel.
• Inspection stations are placed in the area of operation, viz., warehouse, manufacturing and packaging areas.
• analytical laboratory should be in an accessible area and protected from noise and vibration common to manufacturing operations.
• Analytical Laboratory - In order to perform physical and chemical analysis, the analysts should know the usual gravimetric analysis. Furthermore, they should be skillful in handling instruments for
• staff in a biological testing laboratory should be well trained and experienced in both simple and complex microbiological procedures and biological interactions.
• Biological Testing Laboratory - They should posses a high degree of skill and judgment in order to perform the job.
• A veterinarian is recommended to supervise the care and maintenance of the various species of animals used in the test.
• Biological Testing Laboratory - To perform and evaluate microbiological and pharmacological assays, sterility, pyrogen and bacteriological tests, irritation, safety or acute toxicity tests.
• Biological Testing Laboratory - To conduct environmental monitoring.
• Sterile conditions should be provided for areas where biological tests are conducted.
• Noise should be Precluded from areas where animals are used.
• An animal house should be maintained as a Separate unit from the main laboratory, if necessary.
• Specifications and Analytical Development - This section should have firm background not only in the principles of quality control and analytical procedures but also in manufacturing, research, product development and in statistics
• Specifications and Analytical Development - To coordinate with research, product development, production, sales and management towards improvement of a product.