Quality Control / In-Process Quality Control

Quality control is an essential operation in the pharmaceutical industry. Pharmaceutical drug products must be marketed as safe and therapeutically active formulations with consistent and predictable properties and performance. As new and better medicinal agents are rapidly evolving, so are there more exacting and sophisticated analytical methods being developed for their evaluation.

According to the World Health Organization (WHO), the term quality control refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical.

Quality control in particular is the area of good manufacturing practices (GMP) which deals with processes involving sampling, specifications and testing, and with the organization, documentation and release procedures. These help ensure that the necessary and relevant tests are executed and that materials are not released for use, nor products released for sale or supply, until their quality has been confirmed to comply with international standards.

This attribute of a pharmaceutical preparation cannot be easily measured and assured during in-process inspection and finished-product testing, since every stage of the manufacturing process affects the properties of the drug. This key fact opens up the necessity to properly train all personnel– from the basic concepts of assuring quality like donning on their personal protective equipment (PPE) prior to entering production sites; up to the complex protocols of aseptic technique.

Additionally, a consistent yield of products of the highest calibre will not only depend on the operators, rather, even the material of construction of the cleanrooms and various equipment used for handling and preparing the final products can be of influence. As such, a keen sense of attention to detail is essential.

It is also important to note that quality control is not confined to laboratory operations but must be involved in all decisions concerning the quality of the product; from the purchasing and storage of raw materials, to the in-process quality control testing, up until the labelling and packaging of the final product.

Esco Pharma with its wide range of innovative and turnkey solutions, backed with its four (4) core technologies enables various industries such as pharmaceuticals, nutraceuticals, and cosmeceuticals to comply with the internationally accredited GMP, as well as, industrial, environmental, and health and safety standards.

References:

1. Levi, L., Walker, G., & Pugsley, L. (1964). Quality Control of Pharmaceuticals. The Canadian Medical Association Journal, 91 (15). Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1927659/pdf/canmedaj01069-0002.pdf
2. U.S. Food and Drug Administration. (2011). Guidance for industry- Process Validation: General Principles and Practices. Retrieved on 17-May-19. Retrieved from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-validation-general-principles-and-practices
3. World Health Organization. (n.d.). Quality Control. Retrieved from: https://www.who.int/medicines/areas/quality_safety/quality_assurance/control/en/
4. World Health Organization. (2007). Quality Assurance of Pharmaceuticals: A compendium of guidelines and related materials (2nd ed.). Retrieved from: https://www.who.int/medicines/areas/quality_safety/quality_assurance/QualityAssurancePharmVol2.pdf

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