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.
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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