securPharm has released coding regulations by means of the Data Matrix Code. The document also addresses the automated identification of medicinal product packages in the pharmaceutical supply chain. In addition, requirements about clinic packs are also available. Read more about the securPharm regulations on the coding of medicinal products subject to mandatory verification.
EMA's "Reflection Paper" from May 2016 on dissolution testing for immediate release of oral dosage forms deals with the specific requirements concerning the tests which should be taken into consideration when submitting applications for a marketing authorisation. Get the details about EMA's Reflection Paper on dissolution specification.
On 2nd March 2017, the US FDA and the EU (EMA) informed that they concluded a so-called MRA (Mutual Recognition Agreement). Such agreements are intended to mutually recognize GMP inspection systems. As a consequence, the GMP Compliance of a site is reviewed by the respective inspection authority. Afterwards, the FDA can use EU inspection results and vice-versa. Read more about the FDA//EU MRA Agreement.
During the inspection of an Indian API facility, FDA investigators found that basic requirements for GMP-compliant manufacturing weren't complied with. This led to a Warning Letter. Read more about the detailed deficiencies in cleaning and validation of test methods, and the maintenance of analytical devices.
The premises dedicated to the manufacture of medicinal products have to be monitored. Depending on the type of product to manufacture and whether it is a sterile or a non-sterile medicinal product, the requirements for cleanroom monitoring are more or less demanding.
A draft for Ph. Eur general chapter 3.2.3. Sterile plastic containers for human blood and blood components has recently been published for comments in Pharmeuropa. It is proposed to delete the abnormal toxicity test (2.6.9) (ATT) from the Tests section.
In the draft revision of Annex 15 of the EU GMP Guide (Validation / Qualification) there were significant changes in the chapter on cleaning validation threshold determination. Which of these changes will still to be found in the final document? Read on here.
In the Pharmacopeial Forum of the USP the revision of the General Chapter <197> on Spectrophotometric Identification Tests is proposed. As part of the revision, the sections NIR and RAMAN would be newly included. Get more information about the planned update of the USP on identification tests.
The safety features required for the implementation of the Anti-Counterfeit Directive will have to be implemented by the 9th February 2019. The European Commission has released version 5 of its Questions and Answers on safety features and the German initiative securPharm has just published the Status Report for 2017. Read more about the SecurPharm Status Report 2017 and about the EU's Q&A document on safety features.
Certificates of Analysis (CoA) have to be issued for excipients, APIs, packaging materials and finished products. Regarding those certificates, there are a number of guidelines. A closer look at these guidelines shows that there are several regulatory requirements which are often unknown. Read more about GMP/FDA compliant Certificates of Analysis (CoA).
Following an FDA inspection, a manufacturer of sterile medicinal products in the UK has received a Warning Letter due to serious violations of GMP. As often in such cases, the inspection was preceded by another one where GMP deviations had been observed but to which the company had responded insufficiently. Read more about this Warning Letter here.
The European Pharmacopoeia's revised monograph 169 on water for injection (WFI) will become effective by the 1st of April 2017. For the first time in Europe, a monograph will allow the production of WFI with other methods than distillation. But there are still unanswered questions, e.g. how to deal with HPW systems which have been already producing water with WFI quality. Read more about the revision of the Monograph on WFI.
In December 2016, the FDA published a guideline setting specific requirements on how trading partners can identify suspect products and inform the FDA about them. Read more information about FDA's current document "Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification" here in this News.
The Drug Commission of German Pharmacists (AMK - Arzneimittelkommission) regularly informs about batch recalls - e.g. due to quality defects. Now, there have been more and more reports about batch recalls due to counterfeit medicines. According to a report of the German newspaper "Deutsche Apotheker Zeitung" edition 5/2017, the company axicorp Pharma is facing such a counterfeits case. Read more about it here.