QUALITY CONTROL

SECTIONS

1. Physical and chemical testing section
2. Microbiological testing section

ROLE OF QUALITY CONTROL

Adequate independent QC department involves in sampling, developing the specifications/procedures, testing, validations and qualifications, approval and rejections of medicines.

SAMPLING & TESTING

Sampling and testing includes but is not limited as follow for qualitative and quantitative analysis.

1. Starting Materials [Active pharmaceutical materials (API) and Inactive materials]
2. For identification of each container prior to use in product
3. For physical and chemical analysis
4. Packaging materials testing (Primary, Secondary, tertiary)
5. Water system
6. Equipment and utensils cleaning and sterilization
7. Carriers in liquids dosage forms
8. In-process control (intermediate products)
9. Finished products
10. Microbiological testing (Bioburden, Microbiological Assay, Sterility, Endotoxin)
11. Stabilities studies testing (real time and accelerated)

PROCEDURE

1. Sampling and samples receiving and handling.
2. Specifications and testing of starting/packaging materials, In process and finished products. validations samples,
3. Reagent, standards solutions volumetric solutions
4. Equipment operations and calibration
5. Documentations and testing records
6. Data integrity
7. Operational logs