AN OVERVIEW OF QUALITY ASSURANCE DEPARTMENT IN PHARMACEUTICALINDUSTRY
Quality is a universal concept and concern for every item or article of use – be it a house-hold item,home appliance, personal care products, machinery purchased from the market, cars for personal orcommercial use, foods and food products – or medicines for animal and human consumption. No onewants to compromise quality on any item they use. Quality assurance therefore is the process or the endof the process of vouching for the integrity of a product to meet the standard for the intended use. Quality assurance is an obligation automatically imposed on the manufacturer of any product to ensure that itmeets the needs of the end-user in the measures intended for use – quality, safety, efficacy, reliability,strength and or durability etc. For the end-user, the benchmark of quality is perfection – they cannot allowless than 100%.
The Pharma Industry
To consummate the objective of quality healthcare delivery, the place and contribution of good, safe,efficacious and affordable medicines cannot be over-emphasized. The surge of fake, sub-standard and adulterated medicines is a global menace. The WHO’s quality medicines policy is geared towards the production and supply of medicines of the highest quality, safety and efficacy at an affordable price.Increased regulation of the pharma industry manifested sharply after the thalidomide disaster of 1957, tomake for stringent, systematic, scientific and sustainable approach to commercial drug production thatguarantees protection of public health. Prior to this, it was the days of the Apothecaries’ extemporaneous preparation of drugs in hospital pharmacies and commercial chemist shops with limited facilities andmanpower, in which decoctions, medicated potions, ointments and emulsions were delivered. World population explosion, industrial and technological revolution, and outrageous economic foragingunzipped the art of drug production, meaning that random involvement of all-comer manufacturers must be regulated with stringent systematic, scientific and sustainable practice controls that must culminate ingood drug product quality.The system of specifications and practice control measures in the industry, also known as standardoperating procedures (S.O.P.s) –
designed by the scientific community and regulatory authorities, andlocalized by each industrial outfit into their own templates – ensures a good manufacturing practice(GMP) when put to use. The strict enforcement of these codes of GMP guiding the manufacture ofmedicines, plus the laboratory follow-up of the manufacturing processes from start to finish, is termedQUALITY CONTROL. So, in broad terms, the elimination of error to the barest minimum throughmanagement control practices leads to a QUALITY ASSURANCE or certification of the product as good,safe, and fit for the intended use. Quality control adopts all GMP measures as per SOPs to ensure theoutput of uniform batches of drugs that conform to established specifications of identity, strength, purityand other relevant parameters. It involves the sampling and testing of starting materials, intermediate, bulk and finished products, plus packaging materials, – to ensure compliance with appropriatespecifications and standards. Quality assurance is the sum total of these processes or, put simply, anassurance that the drug product has been manufactured following GMP, and that it contains necessaryingredients in correct proportions, and is of the right purity, packaged in the right containers and labeledappropriately. Quality control plus GMP equals Quality assurance. [QC + GMP = QA].