GMP,药品,药学,制药,新药,色谱,药品生产,中药,药材,原料药,医药,中间体,药用辅料

2012年EMA的关于EUGMP的修订维护计划

时间: 2012-05-20 13:24:22 作者: 来源: 字号:
GMP Guide: Chapters 1 and 2 (Quality Management and Personnel)
To finalise these chapters as part of the EU implementation of ICH Q10.
GMP Guide: Chapters 3 and 5 (Premises and Equipment and Production)
To undergo a public consultation on the changes to be made relating to the topic of “Dedicated
Facilities” once toxicological input has been developed by the Safety Working Party.
To undergo a public consultation and finalise the amendments to Chapter 5 of the GMP Guide relating
to the qualification of suppliers and supply chain traceability for starting materials, and, to clarify
analytical testing expectations of medicinal product manufacturers with respect to raw materials.
GMP Guide: Chapter 6 (Quality Control)
To undergo a public consultation on the revision aimed at identifying minimal requirements for the
transfer of analytical methods.
GMP Guide: Chapter 8 (Complaints and Product Recall)
To undergo a public consultation on changes to this chapter arising from discussions at a meeting of
Quality Defect contact points held at EMA on 7-8 October 2009 on product shortage notifications and to
introduce specific Quality Risk Management concepts within the context of this chapter. Minor
amendments may also be needed to reflect new obligations arising from the Falsified Medicines
legislation.
GMP Guide: Annex 15 (Validation)
To initiate a review and revision of the Annex as necessary in order to maintain consistency with the
new CHMP guideline on process validation and in the light of ICH Q8, Q9 and Q10.
GMP Guide: Annex 16 (Certification by a QP and Batch Release)
To undergo a public consultation on a revision in the light of recent changes to the GMP Guide,
developments such as Real Time Release Testing, globalisation, and to clarify a number of outstanding
issues.
GMP Guide: Annex 17 (Parametric Release)
To initiate a review and revise the Annex as necessary in view of the revision of the CHMP guideline on
Parametric Release/Real Time Release Testing.
Good Distribution Practice (GDP)
To review and evaluate public comments on the draft revision of the GDP guideline on behalf of the
European Commission.
Work will also be initiated on GMP guidance on storage during transport which will also consider any
impact on other scientific guidelines in consultation with the Quality Working Party and Biologics
Working Party.
EudraGMP database
To continue to fulfil the role of Telematics Implementation Group (TIG) for EudraGMP and to act upon
the recommendations of the EudraGMP IT subgroup formed to advise the TIG.
Depending on budget availability to develop to develop an inspection planning module for third country
inspections and to develop new modules to meet new requirements arising from the Falsified Medicines
legislation:
? Third Country inspection planning
? Database for API manufacturers, importers and distributors registration
? Database for Wholesale Distributor Authorisations and GDP Certificates
? Database for GDP Certificates for APIs
发表评论 共有条评论
用户名: 密码:
验证码: 匿名发表