GLP Guidance documents

An Advisory Document on Test Itemsis being developed by a drafting group, originally under the leadershipof Canada, and now by the United Kingdom, Denmark (Pharmaceuticals) and Italy. The objective of the document is to consolidate text in existing guidance documents that refer to “test item”, as well as promote a consistent approach for performing characterisation of test items. The first draft of the Document was reviewed at the 28th Working Group meeting in April 2014. After subsequent iterations, the latest draft will be reviewed by the March 2017 meeting of the Working Group. It is anticipated that a revised version will be posted on the OECD’s website for public comment in Q2 of 2017.

The United Kingdom and Japan (Medical Products) are leading efforts to develop version three of a public web page concerning Frequently Asked Questions (FAQ) raised by testing laboratories about implementation of GLP, along with responses prepared by the Working Group. (Versions one and two of the FAQ are posted on the public site.)
Version three of the FAQ will include three topics related to whether software programmes developed by outside vendors to support calculations by test facilities using OECD Test Guidelines need to be validated by such facilities, and clarification regarding two issues raised after the publication of the OECD’s Guidance Document No. 16 on the GLP Requirements for Peer Review of Histopathology. The last two issues concern: the retention of correspondence during a peer review of histopathology, and differences of interpretation between a reviewing pathologist and the original interpretation of the study pathologist. The Working Group is reviewing the final draft, and publication is anticipated by Q1 or Q2 2017.

In 2011, a Discussion Group and protected website were established to solicit input from industry and trade associations and quality groups in areas on GLP compliance that may be of concern due to a lack of harmonisation across governments. At that time, industry participants were invited to respond to a series of questions. Based on the comments received to date, the GLP programme developed three publications and is preparing one more. In December, 2015, the website was revised, new members were invited to join, and additional questions posted to solicit input. In total, 64 comments from industry were received. A sub-group is developing a paper with proposed responses for consideration at the 31st Working Group meeting in March 2017. It is anticipated that these questions and responses will be incorporated in Version four of the FAQ document.

OECD members and full adherents to the Mutual Acceptance of Data (MAD) system have provided an itemised list of the chemical product types which are covered within the scope of their GLP compliance monitoring programmes. The list can be found on OECD’s public site
The 13th OECD GLP training course will be held in Cracow, Poland on 2-5 October 2017. The course will comprise lectures and discussions focusing on the practical aspects of GLP inspections, as well as parallel workshops on inspecting computerised systems, practical aspects of a GLP inspection, and practical aspects of non-compliance decisions and compliance reports.
On-Site Evaluations

Under the OECD’s on-site evaluation activity, each GLP Compliance Monitoring Programme (CMP) in OECD and full adherent countries is evaluated every ten years. These evaluations enhance confidence that data receiving authorities are provided accurate and complete assessments of the conduct of non-clinical health and environmental safety studies and of the quality of the data. The programme of on-site evaluations of GLP compliance monitoring programmes in member and adhering non-member countries continues, with six on-site evaluations conducted in 2016 – Austria (medical products), Canada, Estonia, Israel, Mexico and Poland.
Three on-site evaluations are scheduled for 2017 in Slovenia, Greece (medical products, an initial on-site evaluation visit) and Japan (Workplace Chemicals). The reports of five on-site evaluations held in 2016 will be reviewed during the 2017 meeting of the Working Group. (The results of Israel’s on-site evaluation were reviewed at the 2016 meeting, along with on-site evaluation visits to the Slovak Republic, Spain (Pesticide, Feed Additives and Industrial Chemicals), Sweden and South Africa.

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