WHO Technical Report Series, No. 981 - World Health Organization

7. Quality assurance – new approaches
7.1 Quality risk management
The first draft points for guidelines on this topic were initially prepared in 2010
and widely circulated for comments. The Expert Committee commented on the
drafts in 2010 and 2011. Numerous comments were received during the global
consultation phases. During the informal consultation on WHO quality risk
management and quality guidelines held on 28–30 June 2011, it was suggested
that the principles included in these guidelines could be more concise to enable a
timely initial implementation. Full implementation of the quality risk management
(QRM) system and the application of the related tools would necessitate a longer
time frame. The QRM approach was considered by all experts to be a crucial
element of quality assurance in the future.
Subsequent to the meeting of the Expert Committee in October 2011, the
document on QRM was completely restructured on the basis of the numerous
comments made and advice received before and during the consultation. The
aim of the guidelines is to assist the development and implementation of effective
QRM, covering activities such as research and development, sourcing of materials,
manufacturing, packaging, testing, storage and distribution.
The Expert Committee reviewed the document and the most recent
proposals for revisions based on feedback and comments received in response to a
further round of global consultation. Members of the Committee made proposals
for a number of amendments. The Expert Committee adopted the revision of the
guidelines, subject to implementation of the changes approved (Annex 2).
WHO Technical Report Series, No. 981, 2013
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7.2 Pharmacopoeial harmonization
At the International meeting of world pharmacopoeias held on 28 February
to 1 March 2012, the 23 pharmacopoeias present committed to further efforts
towards pharmacopoeias harmonization. The participants acknowledged that
the harmonization of standards would be essential to global public health in the
future. Pharmacopoeial harmonization was also a plenary topic at the two-day
public conference organized by the International Pharmaceutical Federation
(FIP) and WHO in Amsterdam in October 2012.
International meeting of world pharmacopoeias
WHO maintains an Index of pharmacopoeias and had organized a meeting
inviting all world pharmacopoeias included therein, from 28 February to 2 March
2012. Twenty-three pharmacopoeias attended the meeting to discuss challenges
and issues. They committed to working further towards harmonization and to