After a request of the International Council for Commonality in Blood Banking Automation, the FDA published a Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels. Get more details.
Related to the necessary assessment of environmental impacts, the FDA published a Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products. Read more here.
The FDA is committed to compliance with certain deadlines for the processing of change applications and amendments in the approval process for generic drugs. Two recently published "Guidances for Industry" provide some information. Read more.
The Pharmaceutical Inspection Co-operation Scheme PIC/S has published a PIC/S Guide to GDP. This Guide is based on the EU GDP-Guidelines (2013/C 343/01) and quotes the EU Guide almost completely. Read more.
Is it possible to use the results of collaborative trials for analytical methods to prove the laboratory- and product-specific validation of a method? From the perspective of this EMA reflection paper the concrete specifications are missing. These will be developed in the future. Find out more in this news.
The publication of the final ICH Q3D guideline, which has been announced for September of this year, will lead to extensive revisions to chapters and monographs in the European Pharmacopoeia. Find out in what steps the Pharmacopoeia Commission will proceed.
Among the FDA Warning Letters of the past two years there are every now and then letters citing deficiencies in water systems. On the bottom line the reason for objections is always the same. Read more.
In 19 of the total of 92 warning letters of the last two years, shortcomings regarding equipment are part of the complaints. The most commonly cited issues are maintenance (including calibration), cleaning and the qualification of equipment. Read more.
On July 7th the US FDA issued a Warning Letter to Trifarma S.p.A. for violating Good Manufacturing Standards at their facility in Rozzano, Italy. The company produces APIs and had been inspected early this year. Read more about this Warning Letter here
The International Conference on Harmonisation (ICH) is the most significant organisation for the harmonisation of requirements with regard to the authorisation and the manufacture of medicinal products. Read more about the current decisions of the ICH Steering Committees.
An analysis of warning letters issued in the past fiscal year essentially shows the same pattern of frequently cited GMP violations. It also shows a noticeable increase in the GMP deficiencies relating to the qualification of suppliers and their certificates of analysis. Find out more.
A CEP for a starting material offers several advantages, because it can be used for applying for an API CEP, which reduces the effort in the application process. However, this is linked to various conditions, which are described in a new document of the EDQM. Read more about this.
In which cases does the EDQM temporary suspend an existing CEP or definitively withdraw it? When can an ongoing CEP application procedure be closed? You can find answers to those questions in a new document of the EDQM. Read more here.
The applicant for an ANDA in the USA has to submit data of several stability tests. The FDA guidance on this topic coming into force last year left open some issues, however, that now are clarified with a questions and answers document published lately. Read more.
The publication of the revised draft of the EU GMP Guide's Annex 15 is the opportunity for the EMA to get comments on it. The opportunity has been used by the Austrian QP Associaton (aqpa). Read more about the comments.
The FDA published its new Guidance for Industry (GfI) - "Electronic Source Data in Clinical Investigations" in September 2013. The Guidance defines the expectations of the FDA concerning electronic source data generated in the context of clinical trials. Find out more about this Guidance.