The ICH Q12 Guideline complements ICH Q8 to Q11 Guidelines and provides a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. The Q12 guideline highlights the need for an effective PQS as described in ICH Q10 and in compliance […]
I recently had the honour to be invited to speak at the PDA India’s annual conference in Hyderabad. The event was well supported by the local India office of FDA in person and senior FDA personnel (including Carmela Rosa and Jose Melendez amongst others) virtually. It was great to see the FDA continue to support […]
Let’s admit it, whether in our personal or working lives, change is hard! As a species, we like to stick with the known and what works for us. Do many of us switch between Apple and Android devices? Is there a brand of car, beer, or wine that we favor? Why don’t we try other […]
I recently published a blog titled Contamination Control Strategy (Not Just a Regulatory Requirement). In that blog, I discussed the needs and benefits of having a Contamination Control Strategy (CCS). It was a high-level view of the regulatory requirements and benefits of having a CCS, but I did not go into the key details of […]
As you will all be aware, EU GMP Volume 4 Annex 1 and PIC/S Annex 1 (hereinafter referred to Annex 1) for “the manufacture of sterile medicinal products” was published in August 2022 and the majority of the guidance came into force in August 2023. One of the key elements of the guidance was the introduction of Quality […]
In April 2018, whilst I was still an expert Inspector at the MHRA, I wrote a blog on vapour hydrogen peroxide. Having recently joined Lachman Consultants, I thought it would be an ideal time to revisit this subject to understand the current situation with this method and perhaps provide insight as to what Lachman could […]
