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…
Well-written documentation and a comprehensive and well-designed Pharmaceutical Quality System (PQS) can be a manager’s best friend. Pharmaceutical Quality System (PQS) documents: provide guidance and instructions for employees to complete the day-to-day activities are the ‘go-to’ during an audit or inspection are the first reference point when inducting new employees. But designing a good PQS…
It’s probably apparent to most of us right now that disaster brings out both the best and the worst in humankind. Take heart in the incredible acts of kindness reported daily as we recognise the sacrifices and risks that so many healthcare professionals, supermarket workers and delivery drivers are taking to keep the rest of…
Virtual Qualification, how can Pharma 4.0® thinking help during Covid-19 lockdown and what lessons can we apply to virtual qualification? The events of Covid-19 have opened up a new world of vulnerability to all industries, and especially those highly regulated like the medicinal products manufacturers and the possibility of Pharma 4.0® Virtual Qualification as a…
Serialisation labelling requirements (serialization) for pharmaceutical products can improve patient safety, prevent counterfeit products from entering the market, and enable more efficient recalls. Why is serialisation on labelling so important? Supply chains for pharmaceutical manufacturing and medical device production are becoming increasingly complex. Medications move from production (manufacturing source) to shelf (consumers/patients). These supply chains…
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