The data integrity topic raises a number of questions. Current questions are addressed in a loose sequence of News. Question 5: Are regulations necessary for the handling and management of data generated by small systems (e.g. pH meters, filter integrity testers, etc.)?
It's a frequent question what GMP compliant equipment design is or how a system has to be made up in order to be GMP compliant and suitable for the manufacturing of medicinal products/APIs. There is a short and a long answer to these questions around GMP-compliant equipment design.
The WHO has reacted to the changes in the European Pharmacopoeia by issuing a draft guideline on the production of WFI (Water for Injection). The commentary phase is open to the public, comments can be submitted until 20 September 2019.
The European Medicines Agency (EMA) has published a draft guideline on quality requirements for combinations of medicinal products and medical devices (so-called Drug Device Combinations - DDCs). What does the draft contain?
A technical guide on commonly used insulation materials has recently been provided in form of a stimuli article in Pharmacopeial Forum. In particular, a defect catalog for common thermal system components with detailed examples of potential failures is provided.
The objective of the French pilot programme is to follow the recommendations of the CSST to evaluate cannabis prescribing and dispensing, and to collect safety and efficacy data. However, medical cannabis is not expected to be legalized in France prior to the end of 2021.
In a previous news it was pointed out that one EU Member State (Slovakia) was still missing for the complete implementation of the MRA agreement between the EU and the USA. The goal was for all EU Member States to be recognised by 15 July 2019. Now, this goal has been achieved.
In our News dated 25 September 2017, we announced the finalisation of an FDA guideline for the qualification of development tools for medical devices. Since this topic is very important for the FDA, a website has been dedicated to it. It is available on the Internet.
The introduction of a Europe-wide serialization system (often simplified to "Track & Trace") has brought great challenges to pharmaceutical manufacturing companies. In addition, many countries outside Europe are preparing serialization systems. Internationally speaking, Russia is already very far advanced. Read more about the new requirements for Track&Trace in Russia.
New Zealand released a proposed regulatory approach for medical cannabis. The implementation of the medical cannabis program is anticipated to start in the first quarter of 2020. In addition, the document proposes two options for GMP.
According to the pharmacopoeias, parenteralia, i.e. sterile medicinal products for injection purposes, must be 100% visually inspected. In addition to damages to the primary container, the absence of particles has also to be checked. But do these medicinal products also have to be 100% free of particles? Read more here.
The numbering of the Ph. Eur. packaging section 3 has been changed for the 10th Edition following the creation of the new chapter 3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes.
The new CTR becomes applicable six months after the notice of the full functionality of the CTIS. The EMA informed that the CTIS now enters a phase of agile, iterative delivery, to prepare the system for audit.