Quality assurance in pharmaceutical industry is the commitment to ensure that a pharmaceutical product will meet or satisfy standard requirements for quality. In other words, the summation of actions leading to the achievement of pharmaceutical product quality is termed quality assurance. In any organization, quality assurance is employed as a benchmark to compare the quality of a given pharmaceutical product to the standard product.

The framework of quality assurance encompasses Good Manufacturing Practice, Good Laboratory Practice, and Quality Control (Chowdary, 2019). Quality assurance is a wide scope of concept covering all matters involving the quality of a pharmaceutical product, including product design and development. Pharmaceutical product quality assurance ensures that pharmaceutical products are designed and developed such that the standard requirements of good manufacturing practice, good laboratory practice, and good clinical practice are safeguarded.

Pharmaceutical quality assurance ensures that the prototype pharmaceutical product is adequately and correctly processed according to standard procedures before the product is available marketing of distribution. Deviations from standard are reported and investigated. Continuous evaluation of the quality of a pharmaceutical product is conducted even after marketing approval known as product market surveillance.

Quality Control

While quality in pharmaceutical product implies the characteristics of a product from both qualitative and quantitative perspective, it also includes the quality of process as well as the product itself. Control in pharmaceutical product quality assurance refers to the procedure by which decisions are made and implemented with reference to whether production is progressing according to the plan and meeting the previously established standard.

Bioequivalence

bioequivalence in pharmaceutical quality assurance is the standard for approving brand-name and generic drugs world-wide. Bioequivalence is the bas

is for approving generic drugs as established by the Drug Price Competition and Patent Term Restoration Act of 1984 also known as Hatch-Waxman Act. The reduced costs of generic drugs are possible courtesy of potential exemption of expensive preclinical, clinical, and bioavailability study requirements (Niazi, 2015). Emphatically, bioequivalence study is used to confirm that the active ingredients in a given pharmaceutical product work in the same way and in the same duration of time in human body (Niazi, 2015).

The following are FDA requirements for bioequivalence for a generic drug:

Same active ingredients and strength as the brand-name product

Same dosage form and route of administration

·         BE – same amount of drug delivered in the same amount of time as the brand-name product

·         Same labeling except the name of the medication

·         Documented chemistry, manufacturing steps, and quality control measures, Raw materials and finished product specifications should meet the USP specifications

·         Potency and shelf-life/expiration date comparable to the brand-name product

·         Meet good manufacturing practices for the facilities used to manufacture, process, test, package, and label the generic product (Niazi, 2015).

References

Chowdary, K.P.R. (2019). A Textbook of Pharmaceutical Quality Assurance. PharmaMed Press. A unit of BSP Books Pvt. Ltd. www.pharmamedpress.com

Niazi, K.S. (2015). Handbook of Bioequivalence Testing. CRC Press Http://www.crcpress..com