GCP Serious Breaches - the 2018 Edition
A look at the recently published 2018 metrics report for GCP serious breaches reported to the MHRA - and what you need to know about reporting a serious breach.
Compliance matters
PIC/S Meetings April 2019
Posted by:
Mark Birse, Posted on:
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Categories:
Compliance matters, Events and symposia, Good clinical practice, Good distribution practice, Good manufacturing practice, Good pharmacovigilance practice
From 8 to 10 April 2019, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
What does qualification of suppliers mean to you? Risks to patients and to your business
Posted by:
Peter Brown, Posted on:
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Categories:
Compliance matters, Good distribution practice, Good manufacturing practice
Recent cases of criminal attempts to sell falsified and stolen stock into the legitimate supply chain have exposed weaknesses in some supplier qualification processes. A reminder of what companies need to do to protect themselves, the public and the supply chain.
Introducing the GDP Office Based Evaluation and Risk Assessment programme (OBERA)
Gateway inspections are due to commence spring 2019 as the first stage of a new GDP inspection approach which will allow MHRA to increase its level of oversight whilst reducing the regulatory burden on those companies with a large number of sites which perform reduced or limited levels of GDP activity.
How to manage safety reporting in a blinded trial
Posted by:
Gail Francis and Kirsty Wydenbach, Posted on:
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Categories:
Compliance matters, Good clinical practice
Guidance on the unblinding and reporting of serious adverse reactions (SARs) associated with comparator drugs
Risk Adapted Approach – Neonatal Pharmacokinetic Clinical Trial of Ciprofloxacin in Critical Care. Part 2
The benefits of risk assessment in clinical trial planning and how a more proportionate regulatory approach can overcome potential barriers to completing trials
MHRA GXP Data Integrity Guidance: Part 1 - A GCP Perspective
Clarification on the interpretation and implementation of the GXP DI guidance in the clinical trial setting
Quality Culture: Learning from History
Posted by:
David Churchward, Posted on:
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Categories:
Compliance matters, Good manufacturing practice
In today’s computerised, high-tech pharmaceutical environment, it is worth reflecting on the Clothier report conclusions from 47 years ago.
Being signed up to the OECD Mutual Acceptance of Data agreement is anything but MAD!
Why it's a good idea for the UK to be part of the OECD MAD framework
Falsified Medicines Directive: Safety Features
Posted by:
Tracy Moore, Posted on:
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Categories:
Compliance matters, Good distribution practice, Good manufacturing practice, Wider MHRA
Implementation of the FMD safety features in the UK
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