GDP and Documentation

Technical-writing-is-a-science-not-an-art

Technical writing is a science, not an art

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 Annexes - Annex 21

EudraLex Volume 4: EU Annex 21 GMP guidelines

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 …

Form-Use

Form Use – the right way to fill in a form

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 …

form-design

Form Design – It’s all about the white space

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 …

GMP-documentation

GMP Documentation – Top Tips for Writing User-friendly GMP Documents

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 …

Pharmaceutical-Quality-Systems-pqs

Pharmaceutical Quality Systems (PQS) 101

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 …