◆ Outlook: What will bring the GMP Year 2016? (10-Feb-16 ECA)
The previous year 2015 was an eventful year. Again there were new developments in the GMP environment as well as announcements of changes that preoccupied the pharmaceutical industry. 2016 won’t be less exciting, also because now many of the new requirements must be implemented. But aso novelties have to be expected. Here are a few highlights:
A new Annex might be added to the EU GMP Guide: Annex 21 for “Importers of Medicinal Products”. The current concept paper doesn’t reveal much information but a first draft of the new Annex can be expected soon for public consultation. The discussions of the requirements for import in the context of the revision of Annex 16 (“Certification by a QP and Batch Release”) were the impulse for the new document. The future Annex is aimed at importers and will cover requirements regarding import activities which are not part of other GMP regulations so far.
A concept paper on Annex 1 of the EU GMP Guide (Manufacture of sterile Medicinal Products) is currently running. A first draft of the revised Annex should also be expected soon for public consultation. The revision is not supposed to create new expectations, but it will contain some adjustments like for example the consideration of other international sets of rules (FDA Aseptic Guide, ICH Q8, Q9, and Q10) and the clarification of requirements which have been until now controversial or ambiguous. The US-American IEST published the new version of ISO 14644:2015 “Classification of air cleanliness by particle concentration” already last year. It is to be expected that also here the contents will be considered.
Annex 17 of the EU GMP Guide (Real Time Release Testing) is to be completely modified. The change of name alone in the current draft signalises a complete reorientation. In the end, the curent annex 17 “Parametric Release” was restricted to be used for the routine release of products sterilised in the final container without sterility tests on the basis of sterilisation parameters. Now, the revision also includes the implementation of the principles of ICH Q8, Q9, and Q10 which can also be applied to other products. Afterwards certification and release of a batch can be based on the monitoring and the control of critical process parameters and relevant material characteristics, sufficient product and process knowledge and a combination of in-process monitoring and controls which provide sufficient data. Then, a batch release would be justifiable without re-testing a sample of the finished product. For this purpose, the Real Time Release approach must be part of the marketing authorisation. The performance of finished product analytics won’t be accepted if the RTR test approach has delivered unfavourable or non-compliant results.
The US Food and Drug Administration (FDA) has started an initiative to use so-called Quality Metrics for planning its risk-based inspections. A first draft was published in July 2015 for consultation from associations and the industry. FDA’s wish is – after the entry into force – to collect defined quality characteristics i.e. “Quality Metrics” from manufacturers via an electronic portal. With these metrics, the FDA will calculate specific statistics which should enable a risk-based management and planning of FDA’s inspections.
Concerning this, a “Quality Metrics Technical Conformance Guide” should be released in 2016. This is referred to in the list of all guidelines published by the CDER (Center for Drug Evaluation and Research) which are planned this year. The list comprises 102 documents in total divided into 15 categories. The following documents should be highlighted:
In the category “Pharmaceutical Quality/Manufacturing Standards (CGMP)”:
And in the category “Pharmaceutical Quality/CMC”:
Some of these documents were already in the list for 2015. It remains to be seen what will come.
There will be some new developments in the area of Investigational Medicinal Products (IMPs). Last year, the EU Commission published four new public consultations on IMPs. They concern both manufacturing (GMP) as well as clinical trials (GCP) for human medicinal products. The reason is that as soon as Regulation (EU) No 536/2014 will apply to clinical trials, Directive 2003/94/EG won’t be applicable to IMPs any longer. Then, they will have to be manufactured or imported according to the regulations of Delegated Acts or other specific regulations; in other words, new documents have to be created. This could also endanger Annex 13. The question is currently discussed to drop it and replace it with another legal act or to revise it.
◆ ICH publishes Training Modules on “ICH Q3D – Elemental Impurities” (24-Feb-16 ECA)
The ICH has published the long-announced training modules on the ICH Q3D Guideline “Elemental Impurities”. Recently, seven presentations have been put on the ICH website. The presentations deal with the following topics from the Q3D Guideline:
The training modules 8 (three examples of a presentation for a risk assessment) and 9 (FAQs) are still in progress and will be published soon.
ICH’s “Implementation Working Group” which was formed in October 2014 is in charge of the creation of these modules. It has already elaborated similar training modules for the ICH Q8 – 10 Guidelines and one Q&A document for ICH Q11.
The background for the development of the training modules on “Elemental Impurities” is the complexity of the requirements laid down in the Q3D Guideline. This became apparent during its development stage. Many critical comments from companies and industrial associations – mainly during the consultation phase of the guideline – led the ICH to develop practical assistance to both the industry and the authorities in order to ensure a smooth implementation of the guideline.
◆ USP develops new General Chapter on Metal Packaging Components (23-Mar-16 ECA)
The USP Expert Committee “General Chapters—Packaging and Storage” recently announced to develop a new General Chapter <662>. The proposed title is “Metal Packaging Components and their Materials of Construction”.
The Announcement was posted on February 26, 2016 with an input deadline of March 29, 2016.
The suggested audience are suppliers of metal materials and components used for packaging systems (primary packaging components) and drug product manufacturer using metal primary containers. Publication of the proposal in Pharmacopoeial Forum is expected for PF 44 (2018).
Aluminum is one of the oldest packaging materials used for food, for example to wrap chocolate in it. Metal packaging systems were first used to package pharmaceutical products in the early 1900s due to its lightness and its impermeability to light and moisture. Common metal packaging components include aluminum and its alloys, stainless steel, tin-free steel, and tinplate. Within the pharmaceutical industry, primary metal packaging systems can include aerosols, blister packs, canisters, collapsible tubes, drums and gas cylinders, and secondary packaging systems such as overwraps and seals. Currently there are no compendial standards for metal packaging systems. Thus, to help ensure the safety and suitability of metal packaging system for pharmaceutical products, the USP will develop a new chapter that will provide test methods and standards for metal materials of construction and packaging system.
The scope and applications are metal materials and components that make up a primary packaging system. The chapter should be used in helping determine the safety and suitability of metal packaging system for pharmaceutical products.
Furthermore, to initiate the work of the USP Expert Committee, a teleconference will be held by USP to discuss the scope and goals of the General Chapter with interested parties. The intent is to have a dialogue regarding practices that are currently used by suppliers and product manufacturers to ensure safety, suitability and compatibility. The input received during this call will provide a foundation for the first draft of this new General Chapter.
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