CMC Guidelines & More – #ICYMI from the Acorn Regulatory Archive

Each month we feature some of the excellent articles written by our expert staff that you might have missed.  In this month’s edition of In Case You Missed It (#ICYMI) we look at the update to CMC guidelines, we impart some device for Scientific Advice Meetings, we look at the benefits of smart packaging, issues to be aware of with a CEP (a certificate of suitability) and more.

CMC Guidelines and more in #ICYMI from Acorn Regulatory

1. Are You Aware of the Updated CMC Guidelines?

Are you aware of the changes made to the CMC guidelines on the manufacture of the finished dosage form?  We have an overview that will assist you.

The updated CMC guidelines on the manufacture of the finished dosage form, CHMP/QWP/486/95, first issued in April 1996, were updated and the new version, EMA/CHMP/QWP/245074/2015, were made effective in February 2018.

The updated guideline is structured in the CTD format applied to Module 3 section 3.2.P.3 Manufacture.

Read more here.

2. Eleven Commonly Deficient Issues When Applying For A Certificate of Suitability (CEP)

The  Certificate of Suitability or CEP is a certificate issued by the European Directorate for the Quality of Medicines (EDQM) that certifies the compliance of a pharmaceutical substance or active pharmaceutical ingredient (API) with the requirements of the relevant monograph of the European Pharmacopeia and therefore the EU directives for medicines. A list of all CEPs granted is available on the EDQM website.

Many companies encounter a range of issues when applying for a Certificate of Suitability (CEP).  The EDQM have identified a number of areas that arise frequently in CEP applications.

Read more here.

3. What Are The Benefits Of Smart Packaging In The Pharma Sector?

Much has been written about the benefits of smart packaging for the pharmaceutical sector.  The introduction of smart packaging technologies is regarded as another step in safeguarding the security of medicinal products and devices.  Below, we look at smart packaging and consider the benefits that it might bring to our sector.

Read more here.

4. Advice for Companies Attending Scientific Advice Meetings

In this article, we look at the issue of Scientific Advice Meetings.  This is an area where clients and prospective clients consistently seek our support.  Our expert team has significant experience of dealing with relevant agencies for such meetings.  This article looks at a number of issues related to the meetings including the growth in the number of meetings being held annually and what your company can do to prepare for a Scientific Advice Meeting.

Read more here.

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