◆ ICH announces Organisational Changes (26-Oct-15 ICH)
The International Council for Harmonisation (ICH), formerly the ICH held the inaugural meetings of its new Assembly [and Management Committee] on 23 October 2015.
The reforms build on a 25-year track record of successful delivery of harmonised guidelines for global pharmaceutical development, and their regulation. The changes announced today build on that success and will reinforce the foundations of ICH to make it better-equipped to face the challenges of global pharmaceutical development and regulation.
The reforms will mean that ICH is a truly global initiative, expanding beyond the current ICH members. More involvement from regulators around the world is welcomed and expected, as they will be invited to join counterparts from Europe, Japan, USA, Canada and Switzerland as ICH regulatory members. This is matched by the possibility of wider inclusion of global industry sectors affected by ICH harmonisation. The reforms strengthen ICH as the leading platform for global pharmaceutical regulatory harmonisation, and one that brings together in a transparent manner all key regulatory authorities and industry stakeholders.
The changes give ICH a more stable operating structure through the establishment of an ICH association, a legal entity under Swiss law. The association establishes the new Assembly as the over-arching governing body that will be instrumental in facilitating future growth through the participation of new members.
At the end of the inaugural meeting, ICH Assembly members declared “The fundamentals of what the ICH parties are trying to achieve are not changed, but the reforms to the process and organisation were needed to adapt to changes in how medicines are developed and regulated. These changes mark an exciting moment for us to help harmonise and streamline the global drug development process for the benefit of patients around the world.”
◆ Investigational Medicinal Products – Recent Changes in EC Guidance (22-Oct-15 ECA)
As reported before in IMPs: Four new public consultations concerning GMP and GCP published the implementation of the Clinical Trial Regulation 536/2014 resulted in four new public consultations concerning good manufacturing practices and clinical trials for human medicinal products (opened August 28, 2015) with closing date November 24, 2015.
As a consequence Annex 13 is expected to be deleted from EudraLex Vol 4 when the new guidelines “Detailed Commission guidelines on GMP for IMPs for human use” become operational. It carries over relevant principles of Annex 13.
Basically the ideas are the same. However there is more detail in regard of
On the European QP Assocaition website you can find a Synopsis of Annex 13 / “Detailed Commision guidelines for GMP for IMPs for human use”. There you will also find a summary which contains links to the most recent changes being published for consultation.
◆ To what extent does the supply chain for APIs have to be documented? The EMA provides the answer (22-Oct-15 ECA)
Pharmaceutical companies facing an official GMP inspection should be prepared that the Inspector will ask to see a complete documentation of the supply chain of the active ingredients (including appropriate risk assessments) – going back to the starting materials which were used for the synthesis of the APIs. In an update of the Question & Answer collection to the GMP Guide Part 1: “Basic requirements for medicinal products: Chapter 5: qualification of suppliers” the EMA has recently clarified this. According to this, medicinal product manufacturers have to demonstrate that each active ingredient delivery comes from an approved supplier, which, in turn, has to make available the complete documentation of the supply chain for the starting materials. The medicinal product manufacturer has to verify the entire supply chain on a regular basis according to risk-based criteria.
Below, the wording of the statement of the EMA:
“The supply chain for each active substance must be established back to the manufacture of the active substance starting materials. This should be documented and must be kept current. The risks associated with this supply chain should be formally documented. Control of each incoming consignment of active substance should include verification that it has been received from the approved supplier and approved manufacturer. The entire supply chain should be verified for a supplied batch periodically to establish a documented trail for the batch back to the manufacturer(s) of the active substance starting materials. The frequency of this verification should be based on risk.”
◆ ECA publishes revised version of Good Practice Guide on Process Validation (04-Nov-15 ECA)
Since the publication of FDA´s Process Validation Guidance in 2011, validation has become a life cycle approach with focus on process knowledge and process understanding based on scientific sound principles. In addition, with the revision of Annex 15 of the EU GMP Guide, the EU has also been moving to modern process aspects (e.g. life cycle approach).
The question is how to implement these new requirements – in the USA and in Europe?
To answer this question, an ECA Working Group has revised the Version 1 of ECA´s Good Practice Guide on Validation. With the revision the group wants to provide support to both regulators and industry. On one hand, the guide contains the main elements of the new approach (“what to do”). On the other hand, it also serves as a supporting guide for the implementation (“how to do”).
The revised version comprises 174 pages divided in 5 chapters and 5 annexes (with detailed analyses of the regulatory guidances).
The topics covered are e.g.:
The ECA Good Practice Guide on Validation will be officially launched at ECA´s Annex 15 Conference on 25/26 November 2015 in Berlin.
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