GMP News: Complaints and Recalls: new EU-GMP Chapter 8 published
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GMP News: Complaints and Recalls: new EU-GMP Chapter 8 published
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GMP News: If a Facility stores Medicinal Products for more than 36 Hours GDP will apply
Since the EU Good Distribution Practice (GDP) Guide has been revised, a number of questions regarding its interpretation have been raised. One of these questions relates to storage facilities and so called distribution hubs. In the past, many facilities which have been involved in the supply chain were not managed under GDP and didn’t posses a licence for their activities.
The British Medicines Authority MHRA published a press release on 18 August 2014 to explain what they consider to be a facility which must be licensed and which needs to implement the GDP requirements. According to the MHRA: “The GDP Inspectorate is raising awareness of the impact of the new regulations to those parties that are either directly or indirectly affected and any freight consolidator or freight forwarder either in the air, sea or road transport sector that is either holding ambient medicinal products on site for more than 36 hours or has cold room facilities will require a Wholesale Distribution Authorisation WDA(H) in order to comply with the Human Medicines Regulations 2012 [SI 2012/1916] (as amended) and with the Falsified Medicines Directive 2011/62/EU.”
Source: MHRA Press Release: MHRA position on freight consolidation depots (freight forwarders)
GMP News: FDA publishes ICH Q4B – Annex 6 on Uniformity of Dosage Units
On 16 June 2014, the FDA published the ICH harmonised Guideline entitled “Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units General Chapter (Q4B Annex 6)”. This ICH Guideline thus came into force in the USA, too.
The objective of the ICH Q4B Working Group is to reach mutual recognition by regulatory authorities in the ICH regions for all testing methods listed in the ICH Q6A Guideline on Specifications. Through this, comparable testing laid down in the different pharmacopeias shouldn’t be performed separately when it has been assessed by the authorities that those are similar and interchangeable.
The Annex 6 states that the following official texts :
can be used as interchangeable. Nevertheless, certain restrictions listed under the section “Analytical Procedures” have to be considered.
To get more details please see the complete FDA “Q4B – Annex 6 Uniformity of Dosage Units General Chapter“.
PS: At the QbD/PAT Conference from the University of Heidelberg from 15-16 October 2014, Dr Øyvind Holte from the Norwegian Medicines Agency will present the uniformity of dosage units using large sample sizes (Ph.Eur. 2.9.47). Dr Øyvind Holte is a member of both the EDQM PAT working party and the EMA PAT team.
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