GMP News - Validation


APIC updates its Guidance on Cleaning Validation with regard to the PDE Concept

A news in June 2014 already reported about the APIC "Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredients Plants". Now, a revision has brought the APIC guidance in line with EMA's guideline on "Shared Facilities".



Data Integrity - two new documents from PIC/S and EMA

Data Integrity is one of the hottest topics in regulatory activities at the moment. After the publication of draft documents by FDA in April 2016 and MHRA in July 2016, the PIC/S and the European Medicines Agency (EMA) followed on 10 August 2016 with two new documents. Please find here a short overview of the PIC/S draft PI 041-1 "Good practices for data management and integrity in regulated GMP/GDP environments" and the EMA  "Questions and Answers: Good Manufacturing Practices - Data Integrity".



MHRA GxP Data Integrity Definitions and Guidance for Industry: New Draft Version for Consultation

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".



WHO publishes Draft of an Umbrella Guideline on Process Validation

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.



German Company receives FDA Warning Letter for Data Integrity Issues

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.



Final WHO Guidance Document on Good Data and Record Management Practices

The WHO has just released the  the final version of the important guideline "Good Data and Record Management Practices".



EMA publishes finalised Process Validation Guideline for Biotech Products

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". 



Extensive Warning Letter for Indian Manufacturer of Sterile Medicinal Products - Part 2

Again, the US American FDA has issued a Warning Letter to a manufacturer of sterile medicinal products. Extensive and serious violations of the GMP principles have been discovered at the Indian manufacturer Emcure Pharmaceuticals Limited. Part 2 of this News addresses environment and personnel topics. Read more about the most significant deviations in this Warning Letter.



New FDA Draft Guidance 'Data Integrity and Compliance with cGMP' published

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".



FDA gives Advice on the Use of Control Charts

In a previous News from October 2015, we pointed out that the FDA has been observing more and more deficiencies in the area of statistics with regard to process validation. One of the "statistical methods" - also stated in FDA's Process Validation Guideline - is the use of control charts in the context of a statistical process control (SPC). Learn more about the views of an FDA representative on the use of control charts.



Statistics and Process Validation: current Findings of the FDA

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.



ECA establishes new Interest Group on Pharmaceutical IT Compliance

The ECA Foundation has established various working and interest groups concentrating on different topics. To cover IT technologies with regard to international GMP requirements the Foundation now established a new Interest Group on Pharmaceutical IT Compliance.



New WHO Draft on "Good Data and Record Management"

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.



ECA publishes revised version of Good Practice Guide on Process Validation

After the FDA moved towards a life cycle approach with its Process Validation Guidance in 2011, the EU GMP Guide now followed with the revision of Annex 15, also moving to modern process aspects (e.g. life cycle approach). But how can the industry implement the new process validation requirements? The ECA's Good Practice Guide on Validation does provide answers.



Annex 15 and FDA Process Validation Guideline: Similarities/differences from the FDA perspective

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.


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