Maintaining control: Remote working and QP certification
...at the site and an active role in quality management. Inspectors will look for evidence of how often the QP is on site, and their active participation in monitoring the...
Search results for ❤️ PARAS TREFFISIVUSTO: www.Dating4Me.site ❤️ Romeo Miller Dating History
Refrigerated medicinal products, part 2: Transportation, packing, temperature management, the use of third party couriers and returns – some things to consider
Posted by:
Steve Todd, Posted on:
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Categories:
Compliance matters, Good distribution practice, Good manufacturing practice
...so;” The MHRA re-affirm that a licenced site can only be interpreted as being under full GDP control at a licenced WDA site. This applies to all categories of medicines....
Annex 16 QP certification and batch release – frequently asked questions – part 1
Posted by:
Trevor Watson, Posted on:
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Categories:
Compliance matters, Good distribution practice, Good manufacturing practice
...in place soon thereafter will be accepted. The site will need to demonstrate they have identified the high risk sites and have an action plan to ensure the studies are...
ICH E6 (R3) Good Clinical Practice
Posted by:
Andrew Fisher, Posted on:
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Categories:
Good clinical practice, Inside the Inspectorate, Wider MHRA
...also identified in earlier in the quality control section with new text referring to centralised or on-site quality control of such sites. The current section on Monitor’s Responsibilities has been...
Guidance updates on to how to notify the MHRA of changes to the PV System
...within the Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA - GOV.UK (www.gov.uk) and the MHRA website stated changes...
Innovation, Quality & Transparency – a Compliance Team 1 Perspective
Lab assistants doing research. People in white coats using microscope, test tubes flat vector illustration. Laboratory, chemistry, medical test concept for banner, website design or landing web page. Image: (https://www.freepik.com/vectors/lab-technician)...
An Inspector Calls: Part 1, GMP Short Notice and Unannounced Inspections
...early or is postponed at the last minute (for example if a site is found not to ready to be inspected or an incident at the site means we can...
Is your eSystem actually an eCRF (electronic case report form)?
...into. When the database changed to allow site access, the paper CRFs at site became the equivalent of source worksheets, with data being transcribed directly into the sponsor’s database. The...
Overview of compliance management escalation processes used by the GMP Inspectorate
Posted by:
Alan Moon, Posted on:
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Categories:
Compliance matters, Events and symposia, Good distribution practice, Good manufacturing practice, Inside the Inspectorate
...inspection team thinks there is a possibility of escalation they will stop the inspection and let the site know. This pause gives the site the chance to inform the right...
GMP Inspectorate: blood compliance report assessment process
Posted by:
Michelle Yeomans, Posted on:
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Categories:
Compliance matters, Good manufacturing practice
...team of GMP inspectors review automated BCR risk scores and wider intelligence such as compliance history, and SABRE reports to identify triggers for inspection. A key aim of the MHRA’s...
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