The final release of drug products without the documented prove of compliance with the specifications is a criterion for exclusion, and not just during an FDA inspection. Find out, what other GMP violations regarding the manufacturing and testing FDA inspectors found during an inspection.
In December 2017, the FDA published a new draft guideline for homeopathic products. There is to be a more stringent and risk-based approach by which all products are to be recorded. Find out more about the new FDA requirements for homeopathic products.
On 09 March, 2018, the British supervisory agency MHRA published the final version of its guideline on data integrity which has been available as a draft since July 2016. Find out more on a first analysis of the new document "GXP Data Integrity Guidance and Definitions" .
Drug manufacturer Shanghai Weierya Daily Chemicals in China received an FDA Warning Letter in February 2018. During the inspection, the inadequate sampling when testing active pharmaceutical ingredients and excipients was criticised. Read more about the recent Shanghai Weierya FDA warning letter.
The South Korean company Celltrion had received a so-called 483 FDA report as a result of inspections performed in May and June 2017. Deficiencies were mainly observed in the aseptic area. Due to the - in their opinion - insufficient answer to the 483 report, the FDA has now issued a Warning Letter. Read more here.
With the Annex 15 revision, the issue of process validation became significantly more complicated. What is an authority's view on the topic of process validation?
In January, the VDI has published a completely revised edition of part 1 of the VDI 6022 series. The guideline deals with hygiene for HVAC systems with the objective of preventing negative effects on room air.
FDA published the second revision of their Guidance for Industry "Microbiology Data for Systemic Antibacterial Drugs -Development, Analysis, and Presentation" to define the requirements on a overall microbiology development program for such products.
Concerning their activities in the field of ATMP, the EMA Committee for ATMP (CAT) published their work plan for 2018 for the different areas of responsibility from pre-authorisation to used technologies.
Relating to the ongoing experiences in the marketing authorisation of ATMPs, the EMA published an updated version of their "Procedural advice on the evaluation of advanced therapy medicinal product in accordance with Article 8 of Regulation (EC) No 1394/2007".