The therapeutics goods industry is stuffed to the gunnels with very smart people; those who know the inside and out of all the processes and procedures in their field. They are the people that you want on board to …
Once the Pharmaceutical Quality System (PQS) (as per ICHQ10: Pharmaceutical Quality System) is implemented, it must be ensured that it continues to be effective, and for this to happen there has to be a clear commitment from senior management …
‘Continuous Improvement’ or ‘Continual Improvement’ within a quality system can be described as a process of ongoing improvement of products, services or processes through incremental and/or breakthrough improvements. Within the Pharmaceutical Industry, it’s important that companies ask themselves how …
Technical writing, in the context of the therapeutic goods industry, applies to those documents which instruct, define or report on regulated manufacturing activities; that is Standard Operating Procedures, forms, validation reports, and Design History Files, to name so very …
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 …
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 …
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 …
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 …
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 …
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 …
