In this blog I would like to share my 10 tips for writing user friendly SOPs as part of your GMP Pharmaceutical Quality System. The other day I was informed by a client that no-one on their site reads procedures and the only function SOPs performed was ticking a compliance check-box. In my experience this…
Clinical Evaluation EU-MDR requirements This article provides a brief overview of Clinical Evaluation requirements as described in the European Medical Device Regulation – EU MDR [Regulation (EU) 2017/745]. What is meant by the term ‘clinical evaluation’ in the EU MDR? The EU Medical Device Regulation (EU MDR) defines clinical evaluation as “a systematic and planned…
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 to a Quality Culture. There are several ways senior management can demonstrate their commitment to the…
‘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 continuous improvement has been built into the Pharmaceutical Quality System (PQS). The term may appear in…
FDA Citation Tracking Tool Updated I’m excited to share that QikSolve has helped us to update track and trend all the FDA inspection 483 citations from 2011 to current months. This tool dynamically scrapes data from various live websites and databases and provides a single, secure portal which to track and trend data, or rather…
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 few and which are also referred to as “controlled documents”. So that these documents can be…
It has been a big year for industry as organisations scramble to be in full compliance with PIC/S PE009-13. With the due date on January 1st 2019, this deadline is coming sooner than many of us would like! On the 12th September, I attended the CAPSIG NSW/TGA seminar in Sydney which provided an insight into…
PE00-015 Guide to Good Manufacturing Practice for Medicinal Products has recently been adopted by the TGA in Australia. Notably, this update splits Annex 2 into Annex 2A: Advanced Therapy Medicinal Products and Annex 2B: Biological Medicines separately: Annex 2A: Manufacture of Advanced Therapy Medicinal Products for Human Use (ATMP) harmonises with the EudraLex Volume 4…
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