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Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
Comply with good pharmacovigilance practice and prepare for an inspection.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
How to join the phase I accreditation scheme.
Keep up to date with the latest information from the UK GLP monitoring authority.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK.
Guidelines to help mitigate and manage medicine shortages.
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
A proposed format to help prepare responses to good distribution practice (GDP)/good manufacturing practice (GMP) post inspection letters.
The review of the safety of isotretinoin has concluded.
A poster explaining the different symbols used on medical devices.
10 guiding principles that can inform the development of good machine learning practice (GMLP).
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Information for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
What 'single-use' means and what symbol is used by manufacturers to show this.
A practical guide to using medical devices in a range of healthcare settings.
Guidance for industry on flexible approaches we are taking on good distribution practices.
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