This section includes all the latest news and information about Good Manufacturing Practice.
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19 Dec 2011 | Annex 16 concept paper open for consultation
A concept paper on revising Annex 16 of the guide to good manufacturing practice: certification by a QP and batch release is currently open for consultation until 31 January 2012.
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05 Dec 2011 | The European Commission has issued a concept paper on the requirement for safety features in line with the falsified medicines legislation
The European Commission has issued a concept paper on the requirement for safety features in line with the falsified medicines legislation.
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24 Nov 2011 | Press release from the PIC/S meeting and events which took place in Cape Town, South Africa from 6 to 11 November 2011
From 6 to 11 November 2011 the Medicines Control Council (MCC) of South Africa hosted the following events in Cape Town, South Africa: PIC/S Sub-Committee on Training, PIC/S Executive Bureau, PIC/S Committee and annual PIC/S Seminar.
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01 Nov 2011 | Good Clinical Practice (GCP) forum launched
A new Agency discussion forum for Good Clinical Practice (GCP) has been launched.
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19 Aug 2011 | New page published on the Inspection Action Group
The Inspection Action Group (IAG) is a non-statutory, multi-disciplinary group constituted to advise the Director of the Inspection, Enforcement and Standards Division on any recommendation for regulatory or adverse licensing action appropriate to the Division.
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20 Jun 2011 | GMP Inspectorate updated team structure
Bronwyn Phillips, Expert Inspector has retired after 21 years with the Agency.
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04 Apr 2011 | New Group Manager, Inspections (GMP/GDP)
Mark Birse has been appointed as the Group Manager, Inspections (Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP)) following Bryan Wright's retirement at the end of March 2011.
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14 Feb 2011 | GMP expectations for manufacturing sites of finished products
The manufacturer's/importer's authorisation (MIA) holder importing a finished product into the UK has a duty to confirm maintenance of the GMP status of the third-country manufacturing operations. This should primarily be achieved by regular audits of the manufacturing sites including any contracted out operations and the maintenance of appropriate technical agreements.
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17 Jan 2011 | Third country voluntary Active Pharmaceutical Ingredient (API) inspections
The MHRA GMP Inspectorate is not currently in a position to carry out voluntary API inspections due to conflicting resource demands and the requirement to perform inspections that are a legal obligation.
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15 Nov 2010 | Updated risk-based inspection risk rating statistics from 1 April 2009 - 14 June 2010
Updated risk-based inspection risk rating statistics from 1 April 2009 - 14 June 2010 have been added to the Good Manufacturing Practice (GMP) section.
