WHO Guidelines for Pharmaceuticals


WHO Guidelines for Pharmaceuticals:

WHO means World Health Organization, The guidelines developed by WHO are prepared through a vast global consultative process involving WHO Member States, national authorities and international agencies; in consultation with the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations, with specialists from industry, national institutions, nongovernmental organizations, etc. The draft guidelines are evaluated during the meetings of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and, if found suitable, adopted as international standards.

WHO Medicines Quality Assurance Guidelines: 
➤ Development, 

➤ Production, 

➤ Quality Control, 

➤ Inspection, 

➤ Distribution, and

➤ Other Related Regulatory Standards. 


Quality needs to be built into the product. The aim of pharmaceutical development is therefore to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. The information and knowledge gained from pharmaceutical development studies provide scientific understanding to support the establishment of specifications and manufacturing controls which will enable to ensure a pharmaceutical product’s quality throughout its life cycle.


Good Manufacturing Practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labeling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.

Quality Control:

The term quality control refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical. Such procedures may range from the performance of simple chemical experiments which determine the identity and screening for the presence of particular pharmaceutical substance (thin layer chromatography, infrared spectroscopy, etc.), to more complicated requirements of pharmacopoeial monographs. Activities extend to the area of quality control laboratories (good laboratory management practices, models, e.g. for certificate of analysis and lists of laboratory equipment, and an external assessment scheme.


Inspections are part of the overall drug quality assurance system. The objective of inspecting pharmaceutical manufacturing facilities is either to enforce Good Manufacturing Practice (GMP)  compliance or to provide authorization for the manufacture of specific pharmaceutical products, usually in relation to an application for marketing authorization. A further aspect of pharmaceutical inspection is monitoring the quality of pharmaceutical products in distribution channels, from the point of manufacture to delivery to the recipient, as a means of eliminating the hazard posed by the infiltration of falsified medicines.


Any comprehensive system of quality assurance must be founded on a reliable system of controlling the quality, safety and efficacy of a finished product delivered to a market. It is important that all manufacturing operations are carried out in conformity with the accepted norms of GMP. The distribution channel and supply chain need to follow quality assurance as well in order that patients are getting quality medicines. WHO has issued a number of international standards assisting Member States and those involved in the supply chain.

Other Related Regulatory Standards:

WHO has also formulated international regulatory standards on several quality related issues, which include stability, packaging, storage, and bioequivalence. Care must be taken to ensure that active pharmaceutical compounds remain stable and unaffected by packaging materials or storage conditions. Further, the establishment of bioequivalence standards between brand and generic drugs is of great importance given WHO's support of generic products and their potential to increase access to essential drugs.

WHO Guidelines for Pharmaceuticals

Post a Comment


Post a Comment (0)