Tax. Return. Form. That sent a shiver down your spine, didn’t it? Because it’s longwinded, boring, complicated, sometimes unintelligible, and usually frustrating. Plus, there’s that added frisson from the fear of imprisonment due to unintentional tax fraud. Form design might seem like a banal topic but I’m pretty sure that we’ve all had first-hand experience…
Good documentation (and well-written procedures) is key to achieving compliance with GMP requirements. GMP documentation should include enough ‘instructional detail’ to ensure that processes are well understood and user friendly, and should be ‘…designed, prepared, reviewed, and distributed with care’. (Clause 4.2, PIC/S Guide to GMP). The hidden costs of poor documentation are significant and…
Circular Project Management sounds like it could very well reflect the real-life processes that take place during the life cycle of a new venture. Sometimes, designing and building manufacturing facilities can feel a bit like you’re on a merry-go-round. “Round, round…” and dare I say it “…right round like a record, baby…” Though obviously cringing…
What is Pre-use Post Sterilisation Integrity Testing (PUPSIT)? PUPSIT stands for pre-use post sterilisation integrity testing. PUPSIT is performed once your sterilising filter is installed to ensure that the sterilisation and installation process has not damaged your sterilisation filter prior to filtration of your product. What do the regulations say? PUPSIT was first introduced to…
What is the Medical Device Single Audit Program (MDSAP)? The Medical Device Single Audit Program (MDSAP) was launched by the International Medical Device Regulators Forum (IMDRF) in 2014 as a pilot program, satisfying the requirements of the pilot program in December 2016. MDSAP allows a MDSAP recognized third party Auditing Organisation (AO) to conduct a…
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