Recent ISPE Good Practice Guide Changes: Controlled Temperature Chambers Commissioning and Qualification, Mapping and Monitoring (2021).

Recent ISPE Good Practice Guide Changes: Controlled Temperature Chambers Commissioning and Qualification, Mapping and Monitoring (2021).

ByNiamh

What were the changes? In 2021, ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring (2016) was updated, to become ISPE Good Practice Guide: Controlled Temperature Chambers Commissioning and Qualification, Mapping and Monitoring (Second Edition, 2021). The addition of “Commissioning and Qualification” to the title reflects the additional focus that these activities receive in…

Wholesaling Medicinal Cannabis products

Wholesaling Medicinal Cannabis products

ByTrevor

Wholesaling of medicinal cannabis products involves the distribution of these products to various entities, such as Authorised Prescribers, pharmacies or other approved third-party outlets. If you are manufacturing medicinal cannabis products then you will likely be supplying them to Authorised Prescribers, pharmacies or other approved third-party outlets either in Australia or overseas. The process of…

Basic Clean Room Requirements | Designs for GMP Clean Rooms
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Basic Clean Room Requirements | Designs for GMP Clean Rooms

ByTrevor

What is a clean room? A cleanroom (GMP cleanroom), in my mind, is a combination of engineering design, fabrication, finish and operational controls (control strategy) that are required to convert a “normal” room to a “clean room”. This blog will attempt to explain the necessary characteristics of a regulated company clean room not producing potent…

Cleanroom Monitoring According to Annex 1
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Cleanroom Monitoring According to Annex 1

ByPharmOut

Introduction For anyone involved in the manufacturing of sterile medicinal products, the recent PIC/S GMP version 17 Annex 1 guidelines are nothing short of a bible. They delineate the rigorous standards necessary to maintain product sterility. One such crucial aspect outlined in these guidelines is cleanroom monitoring. In this blog, we aim to elucidate the…

PIC/S GMP Guide PE 009-17 Quietly Published

PIC/S GMP Guide PE 009-17 Quietly Published

ByTrevor

On 21 June 2023, PIC/S quietly published version 17 of its Guide to Good Manufacturing Practice for Medicinal Products (‘PIC/S GMP Guide’), PE 009-17 effective 25 August 2023. The sole substantive change being introduced with PE 009-17 is inclusion of the revised Annex 1 (Manufacture of sterile medicinal products), which was published in September 2022, after undergoing revision which was extensive in terms…