WHO norms

and standards
WHO has played
a key role for over
50 years in
establishing the
WHO Biological

necessary to
materials as well
as developing
WHO guidelines

s on the
production and
control of
products and
These norms and
standards, based
on scientific

assist WHO Member States in ensuring the quality and safety of biological .consensus achieved through international consultations.

The Organization accomplishes this work through its biological .medicines and related in vitro biological diagnostic tests worldwide.

programme. This . the WHO Collaborating Centers. and the WHO Expert Committee on Biological Standardization (ECBS).

also involves close collaboration with the international scientific and professional communities. regional and national .

. manufacturers and expert laboratories worldwide.regulatory authorities.

Written guidance and reference materials The activities of the WHO biological standardization .

.programme include the development and establishment of written guidance and biological reference materials.

Written guidelines and recommendatio ns describe procedures for the manufacture and quality control testing of biological .

Guidelines provide more general information on a .medicinal products to ensure safe and effective products.

range of topics of interest to National Regulatory Authorities (NRAs) and manufacturers. whereas recommendation .

By adopting these guidance .s establish the technical specifications for manufacturing and quality control of specific products.

national governments ensure that the products .documents in their pharmacopoeias or equivalent legislation.

produced and used in their country conform to current international standards. Regulatory guidance documents also .

advise NRAs and
manufacturers on
the control of
products, with the
aim of
establishing a

framework for
products moving
in international

products differ
from chemical
drugs in that they

viruses.cannot normally be characterized molecularly. or genetically modified microorganisms are of . starting methods such as bacteria.

as well as having the capacity to vary from preparation to preparation. A certain amount of these products.enormous complexity. such as vaccines .

and thus a .against transmissable disease. are also administered to healthy individuals -often children at the start of their lives.

to the greatest extent possible. that they are efficacious in preventing or .strong emphasis must be placed on their quality to ensure.

treating lifethreatening disease. The increasing globalization in the production . without themselves causing harm.

but has also raised .and distribution of these biological medicines has opened new possibilities to better manage public health concerns.

International .questions about the equivalence and interchangeability of medicines procured across a variety of sources.

standardization of starting materials. and the setting of high expectations for regulatory oversight on the . of production and quality control testing.

way these products are manufactured and used have thus been the cornerstone for their continued success. But it remains a field in .

The continuous technical advances in the field offer a promise of developing potent new weapons against our oldest .constant change.

but also put . as well as new ones malaria. genetic deficiencies. to name a few -.public health threats. and AIDS. pandemic influenza.

regulatory authorities.a great pressure on manufacturers. and the wider medical community to ensure that products continue .

to meet the highest standards of quality attainable. Production and Quality: WHO Specifications .

gene therapy. diagnostics. such as vaccines. biotechnology . blood and blood products.Biological medicinal products.

and cell and tissue products rely heavily on international standardization to ensure their .products. cytokines and growth factors.

quality and their equivalence across manufacturers. For over a halfcentury. WHO has been active in the field of biological .

standardization. . bringing together scientists and policy makers on a global scale to find consensus approaches to the manufacturing.

testing and regulatory oversight of these medicinal products. Through the WHO Technical Report Series (TRS) up-to-date .

and international reference materials for the .methods are described for the benefit of its Member States and manufacturers.

Consultations .standardization of assays and testing are established through collaborative studes for global distribution.

giving interested parties the latest information .and expert working groups on technical issues important to the field are also documented.

available on complex issues such as biocontainment of potential pandemic threats. clinical and non-clinical testing of .

and a variety of other topics. DNA vaccines. risks of transmissible spongiform encephalopathies (TSE's). .vaccines.

accine reference preparatio ns .

"To define an internationally agreed unit to allow comparison of biological measurements worldwide" .

WHO provides Biological Reference Materials which serve as reference sources of defined biological activity expressed .

helping physicians and .in an internationally agreed unit. These preparations are the basis of a uniform reporting system.

scientists involved in patient care. regulatory authorities and manufacturing settings to communicate in a common .

language for designating the activity or potency of biological preparations used in prophylaxis or therapy. and .

.ensuring the reliability of in vitro biological diagnostic procedures used for diagnosis of diseases and treatment monitoring.

This concept of using wellcharacterized preparations as references against which batches of biological products are .

assessed remains fundamental to ensuring the quality of biological products as well as the consistency of .

production and are essential for the establishment of appropriate clinical dosing. These preparations are generally intended for use .

national or inhouse working .in the characterization of the activity of secondary reference preparations (regional.

They are made for use in laboratory assays only and should not be administered to humans. .standards).

Establishment of WHO Reference Materials The WHO Biological Reference Materials are established .

through a standard procedure. Annex 2. found in TRS 932. in which representative materials (often one of several candidates .

These scientific studies are .donated to WHO for the purpose) are tested by participating laboratories using their own methodologies.

Upon establishment of the reference preparation by the ECBS.designed and coordinated by a responsible WHO Collaborating Center. the .

and serve as the comparator against which results from . often in International Units.material is assigned a unitage.

. can be standardized and compared. regardless of location or methods employed.laboratories.