With news, trainings and conferences, a comprehensive guidelines database, publications and more the ECA is the leading European training and information services provider in the GMP and GDP environment.
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.