The World Health Organization (WHO) defines the term quality control as, “The sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical. Such procedures may range from the performance of simple chemical experiments which determine the identity and screening for the presence of a particular pharmaceutical substance (thin layer chromatography, infrared spectroscopy, etc.), to more complicated requirements of pharmacopoeial monographs.”
Scope of QC
Pharmaceutical QC aims at investigating manufactured drug
products according to compendial specifications and standards to monitor that
they are of the required quality. QC is concerned with setting up
specifications, drawing samples, testing them, and generating documentation
related to the tests and their reports. QC also evaluates the analysis reports
and ensures that no material is released for use or for supply or sale until it
meets the necessary quality requirements and pre-determined specifications. The
scope of QC is not limited to mere laboratory work; this department is involved
in all situations that involve the quality of the product.
Responsibilities of QC
The responsibilities of QC are as follows:
1. Preparing specifications for all raw materials, packing
materials, finished products, intermediates solvents, and reagents used in
analyses.
2. Inspecting, sampling, and testing of all starting
materials including packaging materials, intermediate, and finished products as
per procedures defined in the Standard Operating Procedures (SOPs).
3. Performing stability testing to assess product stability.
4. Monitoring environmental conditions are met as per
current Good Manufacturing Practices (cGMP) requirements.
5. Preparing analysis reports for the tested samples, and
recording and investigating any results that are Out of Specifications (OOS).
6. Approving product batches for sale after ensuring they
meet the quality, safety, and efficacy standards prescribed.
7. Calibration of all laboratory instruments and devices
used in the testing.
8. Validation of analytical methods used in the testing.
9. Retaining reference samples from each batch of product
released to the market.
10. Reviewing the batch manufacturing and packing records
and assessing the test reports to ensure products are of the desired quality
and have been properly packed and labeled.
11. Participating in any investigation that follows market
complaints about the quality of a product.