Potent Pharmaceutical Drugs – Containment Control Strategy
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Potent Pharmaceutical Drugs – Containment Control Strategy

 Containment Control Strategy A robust containment control strategy is essentials as a growing number of pharmaceutical products contain highly potent active pharmaceutical ingredients (HPAPIs) that are capable of targeting disease selectively and more precisely than other compounds. HPAPIs are more effective medicines that require lower doses and lead to fewer patient side effects, but also…

Australian-first Manufacturing and Hands-on Training Facility
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Australian-first Manufacturing and Hands-on Training Facility

Australian-first manufacturing and hands on training facility to produce medical products for early stage human clinical trials receives funding from MTPConnect’s Project Fund Program PharmOut is proud to partner with these prestigious Australian organisations and would like to congratulate MTPConnect on this initiative to create this Australian-first “hands on training facility” in Brisbane Australia.  Read…

A User Requirement Specification (URS) now mandatory in Australian GMP says PIC/S v13
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A User Requirement Specification (URS) now mandatory in Australian GMP says PIC/S v13

Old news I know, and you probably always have done it this way, but did you know with the January 2018 adoption of PIC/S PE009-13 by the TGA, a User Requirement Specification (URS) is now mandatory? Annex 15, §3.1 and 3.2 state that a User Requirement Specification should be a point of reference in the…