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Along with safety and efficacy, quality is one of the most important criteria to assess the fitness of a medicinal product for use by the patient. This parameter is not something that can be achieved by itself, without any effort. While the earlier concept was to test products for quality, the pharmaceutical industry has now moved on to building quality into products right from the design stage itself. However, quality control (QC) still plays a vital role in giving a high degree of assurance that products are meeting their specifications.
WHO: 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.”
Schedule M: of the Indian Drugs and Cosmetics Act and Rules defines a QC system as follows:
“Quality Control shall be concerned with sampling, specifications, testing, documentation, release procedures which ensure that the necessary and relevant tests are carried and that the materials are not released for use, nor products released for sale or supply until their quality has been judged to be satisfactory. It is not confined to laboratory operations but shall be involved in all decisions concerning the quality of the product. It shall be ensured that all quality control arrangements are effectively and reliably carried out the department as a whole shall have other duties such as to establish evaluate, validate and implement all Quality Control Procedures and methods.”
Scope of Quality Control:
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 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.
Organization of Quality Control:
Drug manufacturers are required to set up their QC labs and employ staff with the necessary qualifications and training to perform the necessary tests. The department must have adequate space to perform all the analyses, store data related to them, and also store reference samples from each batch of products shipped from the company.
Most quality control laboratories are divided into different types of testing – chemical, instrumental, biological, and microbiological.
One of the fundamental requirements for the Quality Control department is that it must be independent of all the other departments. The Quality Control Head must report directly to the topmost authority, and not to the Production Head.
Responsibilities of Quality Control:
Responsibilities of quality control are as follows :
1. Preparing specifications for all raw materials, packing materials, finished products, intermediates and 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 it meets 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 products 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.
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