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].
FPPs and APIs
A pharmaceutical industry could be engaged in the manufacture of finished pharmaceutical products(FPPs) or active pharmaceutical ingredients (APIs) or both. In whichever case, quality assurance is key.
The Quality Assurance Department
In the average manufacturing facility, the key units or departments that are of high regulatory concern arePRODUCTION, QUALITY CONTROL/QUALITY ASSURANCE, WARE HOUSE andENGINEERING/UTILITIES. The mandate of the QA department is to maintain an oversight functionover Production, Analytical laboratory, Warehouse, Utilities/Water supply and the environment (hygiene)to assure that good manufacturing practices, good laboratory practices and good storage practices are in place.
Why a QA Department?
In addition to the need to obviate incidents similar to the thalidomide crisis, the need to protect publichealth from the works of unprofessional and unscrupulous elements gave rise to enunciation of controlmeasures and quality assurance mechanisms. On a regular basis, the regulators are tightening the tenor ofregulation to overcome the wave of compromise in the industry which is on the upward trend due tountamed profiteering and economic aggrandizement. So, it is all about the protection of public health.
Structure and personnel in the QA department.
The QA department must be able to function as an unbiased umpire in the facility in order to be able toeffectively account for quality deficits and cause the utmost input from all concerned units in the processof building quality into the products. So how can this be possible? – by getting the department remainindependent of production and management, free from their over-bearing influences.According to international best practices, and depending on the size and management structure of anorganization, the QA department is headed by a qualified and experienced responsible person in relevantfield(s) of study. Such a person must have sufficient knowledge, training and experience in pharmaceutical sciences, chemistry and or biochemical science. It is important to emphasize years ofexperience. Working under and reporting to the QA head are chemical and microbiological analysts whocarry out in-process and out-of-process analyses of system water, raw materials, intermediates, bulk andfinished products, plus packaging materials – to ascertain compliance.
Reporting line and collaboration
Although the QA is independent, reporting to the CEO or as the case may be, it is not mutually exclusivefrom other departments especially production, with which there must be a horizontal relationship.Production plans and executes the manufacture of the products by strict adherence to GMP, while QAcarries out oversight duties to cross-check the claims of production concerning the process and the product. It also carries out measures to assure the integrity of production starting materials.
Quality Control and Quality Assurance Units
Generally speaking, the running of the analytical laboratory and various process controls falls under aQuality Control Manager or Head who may additionally be saddled with the management of qualityassurance. In some organizations, the two roles are separated under two heads. This depends on themanagement structure and financial capacity of the company.
Quality Concepts.i.
QMS – Quality management system – the overall picture of how an organization carries onits business by standard operating procedures.
TQM – Total quality management – the commitment of packaging the company’s service
system and products in the best quality possible.
QbD – quality by design – the concept of creating quality in the product from design anddevelopment through production to packaging. This speaks to the role of formulation and production in building quality into the product from the beginning.
Some tools of Quality Assurance Department in a Quality Management System
What is the thrust of the QA in the company? It is to maintain a continuous surveillance in the system. This is carried out through
˳ investigations – of deviations, out-of-specifications and out-of-trends results.
˳ root cause analysis – tracing out-of specs to their roots.
˳ change management – nurturing change in the system
˳ quality risk management – a risk-based approach to quality assurance.
˳ quality reviews/annual product reviews.
˳ post-marketing surveillance of the products
˳ recalls management.
˳ training of staff
˳ environmental management and hygiene.
˳ continuous improvement.
Bibliography
1. A.O. Olaniyi et al – Pharmaceutical Analysis and Drug Quality Assurance
2. Leon Latchman et al – The Theory and Practice of Industrial Pharmacy.
3. Remington’s Pharamceutical Sciences.
4. WHO Guidelines for drug products manufacture
5. NAFDAC Guidelines for the registration of Drugs 2009
6. Miller MT, 1991 – Thalidomide embryopathy – A Model for the study of Congenital Incomitant Horizontal Strabismus.Transaction of the American Ophthalomological Society 81 623-624.
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