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level: Organization of Quality Control

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level questions: Organization of Quality Control

QuestionAnswer
Quality Control Manager (COMPONENTS)- Materials Inspection Section - Analytical Laboratory - Biological Testing Laboratory - Specifications and Analytical development - Quality Coordinating Office
Materials Inspection Section:1 To sample and examine all raw materials received 2 Conduct physical tests on: a. all shipments of packaging materials b. all manufacturing, filling and packaging operations 3. Maintain periodic examination on the quality of inventories throughout all phases of storage, shipping and distribution 4 Perform audit which is independent of the work done by product personnel Note: inspection stations are placed in the area of operation, warehouse, manufacturing and packaging areas
Analytical laboratory:1 For testing and approving raw materials, work in-process and finished product 2 To perform chemical and physical analysis / tests and specifications maybe found in several sources as USP, NF, BP and Merck Index
Biological Testing Laboratory:1 Staff must be well trained and experience in both simple and complex microbiogical procedures 2 To perform and evaluate microbiological and pharmacological assays, sterility, pyrogen and bacteriological tests, irritation, safety or acute toxicity tests 3 Conduct environmental monitoring
Sterile conditions should be provided for areas where biological tests are conducted Noise should be precluded from areas where animals are usedTrue
Specifications and Analytical Development:1 Coordinate w/ research, product development, production, sales and management towards improvements of product 2 Establish specifications for raw and packaging materials 3 Validate existing and tentative procedures of testing 4 Establish specifications based on validation procedures 5 Develop new assay methods for in-house use 6 Develop and improve specifications for quality characteristics of the final product being manufactured
Quality Coordination Office:1 Documentation is its main responsibility 2 Maintain and store records that represent the history of the batch from start to finish. ( batch and master formula records, raw mat, analytical record, printed and packaging material inspection reports and retention files) 3 To furnish data that will aid in analyzing product performance in the market ( documents are: stability studies and returned goods reports) 4. Investigate customer complaints 5. Maintain and develop SOP’s