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 […]
