QUALITY CONTROL

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Quality control (QC) is defined as a monitoring system that is used for detecting and correcting analytical errors by establishing performance limits. QC is a procedure or set of procedures intended to ensure that a manufactured product including pharmaceutical and medical products or performed services adheres to a defined set of quality criteria or meets the laid down requirements of the products. QC is similar to, but not identical with, quality assurance (QA). It is a major good manufacturing practice (GMP) carried out in production companies to avoid microbial contamination of finished products. Quality control covers all the aspects of quality assurance (QA) which concerns itself with the control of errors in the performance of tests and verification of test results. A good and sustainable QC practice must be practical, achievable, and affordable. In quality control processes, every available and necessary test including microbial tests to be carried out are conducted at each stage of the manufacturing process.

QC ensures that finished products are not released into the market for consumption until such products have satisfactorily passed the stipulated QC test that pertains to that particular manufacturing process or plant and product. Several pharmaceutical products including drugs, vaccines and injection water are easily contaminated with pyrogens (fever-inducing agents produced by microbes) during the manufacturing process. Thus, the test for the presence of pyrogens in finished pharmaceutical products is one of the typical QC tests conducted to ensure the safety of the product. All culture media, reagents, equipment and other instrument for microbiological analysis must be adequately controlled for optimum performance in order to minimize possible errors due to their usage.

According to the World Health Organization (WHO), quality control is the part of the firm’s process concerned with medicine sampling, specifications, testing, and the organization’s release procedures that ensure that the necessary tests are carried out and that the materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory. Quality control personnel and departments in a pharmaceutical or other related industry perform similar and related tasks that are all geared towards ensuring that the finished products (e.g., food or medicine) are safe for consumption, of high quality and free from contamination. The main function of quality control is to test and verify the product quality against the predefined standards. Products that do not meet the predefined standards are removed from the batch and destroyed. Quality Control department functions for assuring the quality of all the batches manufactured, at every stage of manufacturing/processing Drug Products.

Specific functions of quality control personnel or departments

  1. Analysis of finished products for contamination or defects.
  2. Monitoring of the production environment for bioburden or contaminants.
  3. Microbiological analysis of raw material, water, and other products for contaminants.
  4. Testing both finished products or raw materials for rejection or release into the market for general use by the public.
  5. Stability testing of finished products, and determination of their shelf life.  
  6. They ensure the quality of the finished products manufactured by the industry.
  7. They ensure that guidelines of productions are followed at each stage of production and complies to the predefined national or globally acceptable standards.
  8. Auditing and calibration of the books and equipment used for production to ensure that they are well serviced, cleaned, and are performing to their highest standards and producing the right results especially in the production of finished products free from contaminants and safe for human or animal consumption.
  9. To train staff on good laboratory practices (GLPs) and ensure that they follow laid down guidelines in their duties.  

FURTHER READING

Ashutosh Kar (2008). Pharmaceutical Microbiology, 1st edition. New Age International Publishers: New Delhi, India. 

Block S.S (2001). Disinfection, sterilization and preservation. 5th edition. Lippincott Williams & Wilkins, Philadelphia and London.

Courvalin P, Leclercq R and Rice L.B (2010). Antibiogram. ESKA Publishing, ASM Press, Canada.

Denyer S.P., Hodges N.A and Gorman S.P (2004). Hugo & Russell’s Pharmaceutical Microbiology. 7th ed. Blackwell Publishing Company, USA. Pp.152-172.

Ejikeugwu Chika, Iroha Ifeanyichukwu, Adikwu Michael and Esimone Charles (2013). Susceptibility and Detection of Extended Spectrum β-Lactamase Enzymes from Otitis Media Pathogens. American Journal of Infectious Diseases. 9(1):24-29.

Finch R.G, Greenwood D, Norrby R and Whitley R (2002). Antibiotic and chemotherapy, 8th edition. Churchill Livingstone, London and Edinburg.

Russell A.D and Chopra I (1996). Understanding antibacterial action and resistance. 2nd edition. Ellis Horwood Publishers, New York, USA.

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