GMP NEWS 2015

As a result of the PIP scandal the regulatory basis for medical devices will be revised. One of the planned changes was already covered in a previous news: The QP for medical devices. The requirements for this person were listed in § 13 of the first regulation draft. Now there is a second draft that also comprises changes for this Medical Device Manufacturers' QP.

The US FDA has a new focus of their inspections: the review to the integrity of data. A recent Warning Letter from July 2015 shows again a clear focus on the issue of data integrity. Please find more information in the Current FDA Warning Letter regarding Data Integrity.

Two new concept papers on the planned revision of the EMA/HMPC documents on the quality of herbal medicinal products and on the specifications of herbal medicinal products were published by HMPC on 1 June 2015. Please read on for further information on the HMPC Reflection Papers.

New proposals for checking identities have been introduced in a USP article and published in the Pharmacopeial Forum, together with the planned chapter revision <191>. In future, the checks will be much more flexible. Find out more about the planned Update of the Identity Check in the U.S. Pharmacopoeia.

In July 2015, the second MHRA blog on the theme of data integrity went live. This time, the focus is on designing systems properly. The ALCOA principles are considered to be very helpful. Read more about the MHRA Good Manufacturing Practice (GMP) Data Integrity blog part 2.

An Addendum to the ICH M7 Guideline was recently published. Please find more details about the new Addendum, e.g. examples to calculate acceptable intakes for specific compounds known to be carcinogenic which are described in this document.

Repeatedly we receive questions with regard to the various inspection reports of the U.S. Food and Drug Administration (FDA). There are three main documents.

Everyone can now review 483s, 483 responses, Consent Decree Correspondence and other interesting documents in an Electronic Reading Room of the U.S. Food and Drug Administration (FDA).

Use of the CTD format is mandatory for the registration of traditional herbal medicinal products. Now, the EMA wants to update the HMPC Guideline in this respect. In future, a mock-up will also be part of the Guideline. Read more about the Revision of the EMA/HMPC Guideline.