Experts have recommended ICH Q10 PQS (International Council for Harmonisation - Pharmaceutical Quality System) guidelines on pharma quality systems for effective implementation of revised Schedule M ...

The ICH Q12 guideline aims to harmonize post-approval change management, addressing delays and supply issues in the pharmaceutical industry. Global adoption is limited, with only three ICH countries ...

Indian pharma industry sees that the International Council for Harmonisation (ICH) guidance for industry on Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management ...

The International Conference on Harmonisation’s (ICH) Good Clinical Practice (GCP) guideline (E6) is ripe for review, according to the vast majority of respondents to a members’ poll by the UK-based ...

In anticipation of these new guidelines, TransCelerate assembled a team of experts to evaluate the guidance and develop tools to support adoption of ICH E6 (R3). The array of tools announced today ...

In this interview, Sandra Reid of gChem explains how PROCIPIENT®, its USP-grade DMSO, is uniquely manufactured under cGMP and ICH Q7 guidelines to ensure compliance, consistency, and quality across ...

To the casual observer, the International Conference on Harmonisation (ICH) could appear to be a fusty but uncontroversial group. Yet ICH's position in the highly charged debate over how quality ...

Pharma Lessons is pleased to announce the launch of its newly revised Good Clinical Practice (GCP) online training course, now fully aligned with the latest ICH GCP E6(R3) guidance. This update ...

This training will discuss regulatory requirements for monitoring of pharmaceutical impurities. It will explain how to monitor impurities in pharmaceutical products as per ICH Q3 A/B requirements and ...

The tripartite International Conference on Harmonisation (ICH) Q2 guide on validation of analytical procedures is not new, but it can give very good advice when validating laboratory Total Organic ...