GMP News - Validation

In June 2018 the ICH Assembly agreed to work on a new guideline ICH M11 "Clinical electronic Structured Harmonized Protocol (CeSHarP)".

The Maltese competent authority has performed an initial inspection at the facility of an Indian manufacturer and packer in March 2018. This resulted in a Non-Compliance Statement regarding GMP.

Procedures for the analysis of GMP-liable products must be validated. Read here, what deficiencies involving the validation of analytical methods and the handling of OOS results almost inevitably lead to a Warning Letter.

The coming into force of the new FDA guidance on process validation in 2011 led to a shift in paradigm. Validation is a three-stage life cycle now and also includes commercial production in stage three. What does that mean for implementing the FDA proces validation guidance though? 

With the authorities' increasing attention to data governance and data integrity the ECA's Data Integrity Task Force's just released version 2.0 of its Data Integrity Guide provides an ideal tool for implementing data integrity in practice.

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" .

The PIC/S draft guideline "Good Practices for Data Management and Integrity" requires every company to have a data governance system in place in addition to their existing QM system. But how can such a system be implemented? Find out more about the requirements and specifications of the PIC/S guideline for the pharmaceutical Data Governance System.