An NSF International Company Europe has introduced further measures for unannounced audits of manufacturers by notified bodies. With this in mind, James Pink, VP Europe-Health Sciences Medical Devices at NSF International, provides a little help to prepare for them.
There are two important documents that are ...
Read moreThe upcoming implementation of the International Conference on Harmonisation’s ICH Q3D Guideline for Elemental Impurities and the United States Pharmacopeia (USP)’s General Chapters for Elemental Impurities has triggered its fair share of concern and uncertainty. Some of this is due to the unkno...
Read moreWhenever I carry out an audit, I come away with two nagging questions in my head – “Did I give enough time and attention to those things which are most important?” and “Did I really communicate my concerns effectively to the auditees and are they motivated to make improvements and act on my reco...
Read moreWhether you are new to the business of manufacturing sterile medical devices or a 20-year veteran of the industry, continuous education and training are essential in this ever-changing field. Not only are the standards and regulations related to managing cleanrooms and sterile medical devices ch...
Read moreIf you Google ‘culture’ be prepared for days of reading. Let’s just say, for the sake of expediency, that culture is defined by the actions taken, under pressure, when nobody is looking. Like a moral compass, your Quality Culture keeps you heading in the right direction no matter how stormy and ...
Read more