Quality

1. AN OVERVIEW OF QUALITYASSURANCE DEPARTMENT IN PHARMACEUTICAL
INDUSTRY
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 or
commercial use, foods and food products – or medicines for animal and human consumption. No one
wants to compromise quality on any item they use. Quality assurance therefore is the process or the end
of 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 it
meets 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 allow
less 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 ofthe pharma industry manifested sharply after the thalidomide disaster of
1957, to make for stringent, systematic,scientific and sustainable approach to commercial drug
production that guarantees protection ofpublic 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 and manpower, in which decoctions,
medicated potions, ointments and emulsions were delivered. World population explosion, industrial and
technological revolution, and outrageous economic foraging unzipped 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 in good drug product quality.
The system of specifications and practice control measures in the industry, also known as standard
operating procedures (S.O.P.s) –designed by the scientific community and regulatory authorities, and
localized 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 of
medicines, plus the laboratory follow-up of the manufacturing processes from start to finish, is termed
QUALITY CONTROL. So, in broad terms, the elimination oferror to the barest minimum through
management control practices leads to a QUALITYASSURANCE or certification ofthe product as
good, safe, and fit for the intended use.
Quality control adopts all GMP measures as per SOPs to ensure the output of uniform batches of drugs
that conform to established specifications of identity, strength, purity and other relevant parameters. It
involves the sampling and testing of starting materials, intermediate, bulk and finished products, plus
packaging materials, - to ensure compliance with appropriate specifications and standards.

2. Quality assurance is the sum total of these processes or,put simply, an assurance that the drug product has
been manufactured following GMP, and that it contains necessary ingredients in correct proportions, and
is of the right purity, packaged in the right containers and labeled appropriately. 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 are
PRODUCTION,QUALITYCONTROL/QUALITYASSURANCE,WARE HOUSE and
ENGINEERING/UTILITIES.
The mandate ofthe QA department is to maintain an oversight function over 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
public health from the works ofunprofessional and unscrupulous elements gave rise to enunciation
of control measures and quality assurance mechanisms.
On a regular basis, the regulators are tightening the tenor of regulation to overcome the wave of
compromise in the industry which is on the upward trend due to untamed 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 to
effectively account for quality deficits and cause the utmost input from all concerned units in the process
of building quality into the products. So how can this be possible? – by getting the department remain
independent ofproduction and management, free from their over-bearing influences.
According to international best practices,and depending on the size and management structure of an
organization, the QA department is headed by a qualified and experienced responsible person in relevant
field(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 of
experience. Working under and reporting to the QA head are chemical and microbiological analysts who
carry out in-process and out-of-process analyses of system water, rawmaterials, intermediates,bulk
and finished products, plus packaging materials – to ascertain compliance.
Reporting line and collaboration

3. Although the QA is independent, reporting to the CEO or as the case may be, it is not mutually exclusive
from 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 QA
carries 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 a
Quality Control Manager or Head who may additionally be saddled with the management of quality
assurance. In some organizations, the two roles are separated under two heads. This depends on the
management structure and financial capacity of the company.
Quality Concepts.
i. QMS – Quality management system – the overall picture of how an organization carries on
its business by standard operating procedures.
ii. TQM – Totalquality management – the commitment of packaging the company’s service
system and products in the best quality possible.
iii. QbD – quality by design - the concept of creating quality in the product from design and
development through production to packaging. This speaks to the role of formulation and
production in building quality into the product from the beginning.
Some tools ofQuality 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

4. ˳ environmental management and hygiene.
˳ continuous improvement.
Can we give a passmark to the global efforts at sanitizing the drug market?
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 fordrug products manufacture
5. NAFDAC Guidelinesfor 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.
7. Etc.
Gabriel Akwaja. B.Pharm,MPSN.
Head,Regulation & Research.
PHAMATEXINDUSTRIES LTD,Lagos.
NIGERIA.
+234 7034740300.