OECD Discussion Group on GLP

SARQA Höstmöte 22 nov 2012

Ingrid Sjöberg och Ragnar Hede

Inbjudan och Guidance for Non GovernmentMembers of the OECD Discussion Group, September 2011.

Introduction

• The OECD Discussion Group has been set up to provide non government organisations, who represent sectors of industry that are involved in the organisation and conduct of GLP studies, with a forum which will allow them to communicate and comment on concerns that are likely to impact on their business. • Specifically, the OECD Discussion Group will focus on the harmonisation of GLP standards across the OECD GLP community and address the suitability of current GLP requirements for emerging technologies.

Membership

• Membership of the OECD Discussion Group will be limited to organisations who have been nominated by their government’s permanent representative on the OECD GLP Working Group

Discussion points

• In order to ensure that the discussion group focuses on key issues which are of concern to the majority of its members, the OECD GLP Working Group will ask for comments on just one or two topics at any one time. • The topics which industry members are invited to comment on will be posted on the protected area and members are asked to limit their comments to the current topics. • Discussion points will be reviewed on an annual basis at the OECD GLP Working Group meeting. This will mean that each discussion point will be available for comment for about nine months.

Topics for discussion

• Topics for discussion will normally be posted one month after the OECD GLP Working group meeting which takes place in April or May each year.

• Industry members of the group will then have nine months on average to make their comments. A closing date for comments will be posted on the web site.

Aim

• The primary aim of the discussion group is to harmonise the way in which international inspectorates apply the OECD Principles of GLP and to flag any potential advances in technology which may impact on the ability of test facilities to adhere to the current GLP Principles. • It is important that members of the discussion group limit their comments to issues that have been encountered by their members and where possible provide clear examples.

Review of comments and actions

• All comments received prior to the closing date will be reviewed by an OECD sub group three months prior to the OECD GLP Working Group Meeting. The group will be charged with collating all responses and presenting them for discussion at the meeting. • Following the OECD GLP Working Group meeting a summary of the discussion will be posted on the password protected site along with any proposed actions.

Review of comments and actions , cont.

• If proposals are made which require actions, including the publication of new or updated guidance, it will be necessary to implement a wider consultation process so that all stakeholders have an opportunity to comment. • The OECD have an established process for dealing with this type of situation which will have to be followed before new or revised guidance can be published on their public web site. These procedures are likely to take several months to complete, however, members of the discussion group will be kept informed of progress through the password protected site.

OECD Discussion Group on GLP Members

• EFPIA (Europe)• SoFAQ (France)• BARQA (UK)• DKG (Denmark)• SARQA (Sweden)• FarmaIndustria (Spain)• DGGF (Germany)• ABPI (UK)• SPAQA (Switzerland)• GIQAR (Italy)• Manufacturers’ Association of

Israel

• Abbott Healthcare Products (Netherlands)

• DARQA (Netherlands)• PhARMA (USA)• APHIS (USA)• SQA (USA)• US Crop Life (USA)• SQA RC (Canada)• JSQA (Japan)• BARQA RC (Australia)

Discussions

Inconsistencies in the way of international inspectorates

The application of GLP to emerging technologies

Svensk GLP grupp

OECD Discussion Group on GLP

• OECD Working Group on GLP met from 29-31 May and discussed the two issues

• Over 100 responsesQuality Assurance Test items IT technology

• Three issue groups

Issue groups - remit

• Need for additional guidance or amendments to current guidance?

• Start to draft documents

• Other remarks considered and responses posted if consensus can be reached

• Deadline: the end of September for QA, Test Item and IT. The end of December for other issues.