GMP News - Validation

In January and March 2015, the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) published a "GMP Data Integrity Definitions and Guidance for Industry". The agency has recently published a new version of the Guidance. Please find here a short overview of the new features in the "GxP Data Integrity Definitions and Guidance for Industry: Draft version for consultation".

On 16 May 2016, the FDA issued a Warning Letter to the German APIs manufacturer BBT Biotech GmbH. Read more about the deviations discovered with regard to computerised systems and data integrity.

Approximately two years ago the EMA published a draft guideline on process validation for the manufacture of biotech products. Now the final guideline has been published under the title "Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission". 

In the last years, the topic "data integrity" has become a priority for the FDA. Recently, the Agency has published the draft of a Guidance for Industry on the topic which presents the comprehensive opinion of the FDA on data integrity. Read more about the draft of the Guidance for Industry "Data Integrity and Compliance with cGMP".

The "new" FDA's process validation guideline has been effective since January 2011. One of the considerable changes made to the original validation guideline from 1987 was to put a significantly greater emphasis on statistics in the context of process validation. So far, relatively few inspection deficiencies had been observed by the FDA with regard to statistics. At a conference in September 2015 co-sponsored by the FDA, Grace McNally - Senior FDA official - reported about current "findings" which also address statistical problematics.

Data Integrity as a topic has become one of the main focuses of the regulatory authorities. Mid-September, the WHO published a draft guidance for comment on this topic too. Read more about the WHO Draft Guidance on Good Data and Record Management.

The "new" FDA Process Validation Guideline has been in force since January 2011. The revised Annex 15 has been valid since 1 October 2015. At a Conference in September 2015, which was co-sponsored by the FDA, Grace McNally, Senior FDA Official, reported about similarities and differences between the two documents from the perspective of the FDA.