西瓜播放器v1.12:GMP News: New Compilation of Community Proced...
来源:百度文库 编辑:九乡新闻网 时间:2024/10/05 23:45:58
GMP News
30/03/2011
New Compilation of Community Procedures on Inspections and Exchange of Information
The European Medicines Agency (EMA) has updated the Compilation of Community Procedures on Inspections and Exchange of Information, formerly known as the Compilation of Community Procedures on Administrative Collaboration and Harmonisation of Inspections. It is meant to be a tool for facilitating co-operation between the GMP inspectorates of the EU Member States and a means for achieving harmonisation. This is to achieve consistency in inspection standards between GMP national pharmaceutical inspectorates and thus to facilitate mutual recognition of those inspectorates.
This Update is the12th revision, including a new procedure for inspecting wholesalers.
It is also pointed out that the pharmaceutical inspectorate should establish and maintain a defined liaison with units responsible for marketing authorisation in order to facilitate actions against marketing authorisation following an inspection, if appropriate.
Changes and updates have also been made for the rapid alert system procedures. Regarding inspection process and planning, the risk based approach is reflected in more detail. Annex 3 provides detailed guidance on the conduct of inspection of a manufacturer of active substances.
Also the procedure on "Issue and Update of GMP Certificates" and the "Procedure for Dealing with Serious GMP Non-compliance or Voiding/Suspension of CEPS Thus Requiring Coordinated Administrative Action have been revised.
EMA is responsible for maintaining and publishing the Compilation of Procedures on behalf of the European Commission. It is a collection of GMP inspection- related procedures and forms agreed by the GMP inspectorates of all the Member States and designed to facilitate administrative collaboration, harmonisation of inspections and exchange of inspection-related information. Article 3 of the GMP Directive, 2003/94/EC, requires Member States to take account of these procedures, and they are used as the basis for standard operating procedures of the quality systems established within the inspectorates themselves.
Source:EMA
You can find a detailled electronic comparison of the with the previous document in theECA Members Area.
30/03/2011
New Compilation of Community Procedures on Inspections and Exchange of Information
The European Medicines Agency (EMA) has updated the Compilation of Community Procedures on Inspections and Exchange of Information, formerly known as the Compilation of Community Procedures on Administrative Collaboration and Harmonisation of Inspections. It is meant to be a tool for facilitating co-operation between the GMP inspectorates of the EU Member States and a means for achieving harmonisation. This is to achieve consistency in inspection standards between GMP national pharmaceutical inspectorates and thus to facilitate mutual recognition of those inspectorates.
This Update is the12th revision, including a new procedure for inspecting wholesalers.
It is also pointed out that the pharmaceutical inspectorate should establish and maintain a defined liaison with units responsible for marketing authorisation in order to facilitate actions against marketing authorisation following an inspection, if appropriate.
Changes and updates have also been made for the rapid alert system procedures. Regarding inspection process and planning, the risk based approach is reflected in more detail. Annex 3 provides detailed guidance on the conduct of inspection of a manufacturer of active substances.
Also the procedure on "Issue and Update of GMP Certificates" and the "Procedure for Dealing with Serious GMP Non-compliance or Voiding/Suspension of CEPS Thus Requiring Coordinated Administrative Action have been revised.
EMA is responsible for maintaining and publishing the Compilation of Procedures on behalf of the European Commission. It is a collection of GMP inspection- related procedures and forms agreed by the GMP inspectorates of all the Member States and designed to facilitate administrative collaboration, harmonisation of inspections and exchange of inspection-related information. Article 3 of the GMP Directive, 2003/94/EC, requires Member States to take account of these procedures, and they are used as the basis for standard operating procedures of the quality systems established within the inspectorates themselves.
Source:EMA
You can find a detailled electronic comparison of the with the previous document in theECA Members Area.
GMP News: New Compilation of Community Proced...
GMP News: Production of WFI through Membrane ...
GMP News: Extension of the Variations Regulat...
GMP News: New EMA Checklist should help Type ...
BBC News - Graduates - the new measure of pow...
GMP News: Dedicated Facilities: FDA publishes...
EU GMP Guide: New Requirements adde...
GMP News: Video Presentation from FDA′s Dr Mo...
New PIC/S Document on GMP for APIs
New channels of marketing cosmetics
The New Fable of the Bees
Rise of China top news of the century - Peopl...
Exclusive: An Early Look At News.me, The New ...
Giant panda victim of bad weather CCTV News
U.S. Secretary of State celebrates Lunar New Year
Customer change of assets, marketing the new rules,
The Rise of the New Global Elite - Atlantic Mobile
China's kind of new heavy bomber - Focus disc...
Throughput of Wuhan new port zone increases i...
CPC embarks on new path of social management ...
Challenges and troubles for the new head of P...
Guangdong special funds for development of new industries
Charter Hire Of 2 Nos New Generation 300ft / ...
New York prosecutors ask for dismissal of Str...