EudraLex, Volume 4 – Good Manufacturing Guidelines European Union: EU GMP Guide Updates – EU Annex 21 (News) Manufacturers/Importers and Sponsors who import medicinal products into the EU/EEA must now comply with EU Annex 21 GMP requirements. Background to EU Annex 21 GMP guidelines for importation of medicinal products EU Annex 21 timeframes When did…
To comply with the requirements of GMP, manufacturers must ensure that any material or service providers that they use are able to meet strict quality standards. This is due to the potential impact of materials or services on the quality of a final therapeutic product. Achieving this standard requires that a number of procedures are…
Electronic signatures (E-signatures) are becoming more and more commonly used in today’s world. Before electronic signatures were recognized and accepted legally, documents had to be manually signed by each of the signatories, stored and filed in squeaky compactors (compactus to some) held within a rather dark records room. Obviously, this process is very time consuming…
Following on from the previous blog Form Design – it’s all about the white space, comes the exciting part deux: Form Use – the right way to fill in a form. There is a general misconception that data integrity failures only result from acts of deliberate fraud. … the majority of issues relate to: which…
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…
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…
Well-designed cannabis production workflows can help business owners understand the benefits of efficient and secure operating procedures in Medicinal Cannabis cultivation and production/manufacturing. When it comes to the production of pharmaceutical-grade cannabis products and extractions (medicinal marijuana products), errors are extremely costly. A mistake can lead to crop damage, excess waste, higher cultivation and production…
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