| 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 used | True |
| 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 |
