One and a half year after its publication, the ICH Q3D guideline still raises many questions. The EMA has recently published a guideline draft aiming at clarifying the practical implementation of ICH Q3D. Read more here about what is expected in a marketing authorisation application or in an application for a CEP with regard to risk assessment and the control of elemental impurities in APIs and medicinal products.
On June 24, 2016, the USP announced the elaboration of a new general chapter <1220> regarding life cycle management of analytical methods. Read more about the new general chapter <1220> "The Analytical Procedure Lifecycle".
In a recent Pharmacopeial Forum two revised USP general chapters have been published for comment. With these drafts, the USP expert committee is removing the requirement for <87> Biological Reactivity Tests, In Vitro testing for packaging materials and systems for oral and topical dosage forms. Read more about the draft chapters of <661.1> Plastic Materials of Construction and <661.2> Plastic Packaging Systems for Pharmaceutical Use.
On June 16, 2016, the US Food and Drug Administration, FDA, published a draft guidance on "Quality attribute considerations for chewable tablets". Read more about the critical quality attributes recommended for chewable tablets.
The recently issued FDA Guideline on Elemental Impurities as a draft describes the procedure for controlling elemental impurities for medicinal products with and without official USP monograph. Read in what cases the FDA expects the fulfilment of the requirements of the Guideline ICH Q3D respectively of the general USP Chapter <232> und <233>.
At the end of 2015, the WHO adapted its Appendix 7 to the latest technological standards. Appendix 7 provides support with regard to non-sterile process validation. Now, further changes to WHO guidelines are in sight. One of these changes concerns the guideline on process validation which is currently available as a draft and can be commented on until July, 12th 2016. Please find here an analysis of this draft.
On 20 May 2016, the U.S. American FDA published a Warning Letter for major hygiene issues in aseptic manufacturing. Find out more about the Warning Letter issued for the Italian manufacturer Corden Pharma Latina S.p.A.
During the development of combination products, "Human Factors Studies" have been gaining importance with regard to design and development. After the FDA had received many requests on how to perform such studies, a new Draft Guidance on Human Factors Studies in Combination Product Design and Development has been elaborated.
The ECA regularly publishes statistics of Warning Letters issued by the FDA to medical devices manufacturers. For some time, the FDA has also been publishing statistics regarding deficiencies with regard to the Quality System of medical devices manufacturers. What were FDA's findings in 2015?
The FDA has published a supplementing Guide on Quality Metrics. This is a very unusual step as the contents of the guide are planned to be integrated into the Guideline on Quality Metrics which hasn't been finalised yet. Read more about the Technical Quality Metrics Guide.
Asia has been in the centre of attention when it comes to GMP non-compliance. This time the company KO DA Pharmaceuticals Co has been inspected by FDA and received a Warning Letter. Read more about the FDA Warning Letter here.
Again, the company Orifarm must recall batches because of suspicion of falsification. The company located in Leverkusen, Germany has received information from the Greek Competent Authority according to which falsified blisters emerged. Read more about the current case of counterfeits.