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Remote Auditing versus On Site Auditing

Remote Auditing versus On Site Auditing

by Charlotte Abbott | Jul 22, 2021 | Audit, Blog

Remote Auditing versus On Site Auditing: For the last 16 months the pharmaceutical world has had to get used to remote auditing as opposed to auditing in person.

Risk Assessments – Evaluating hazards

Risk Assessments – Evaluating hazards

by Charlotte Abbott | Jul 22, 2021 | Blog, Risk Assessments

Risk Assessments: The aim of writing one is to evaluate hazards, then remove that hazard or minimise the level of its risk by adding control measures, as necessary.

WDA(H) & Import – New Guidelines:

WDA(H) & Import – New Guidelines:

by Sally Finlayson | Jul 21, 2021 | Blog, Brexit, GDP/RP, MHRA, RP, Training, WDA(H)

Following Brexit and GB leaving the EU the MHRA have advised that GB wholesale dealers now need to appoint an RPi

API registration

API registration

by Steven Hewison | Jul 21, 2021 | API Registration, Blog

API registration is an MHRA requirement if you manufacture, import or distribute active substances and you are based in the UK.

New Contract RP introduction

New Contract RP introduction

by Steven Hewison | Jul 21, 2021 | Blog, MHRA, RP

New Contract RP says hello! Please allow me to introduce myself as the newest member of PCL’s Contract RP Team.

Export & WDA(H) – Updated Guidelines:

Export & WDA(H) – Updated Guidelines:

by Sally Finlayson | Jul 14, 2021 | Blog, Export Training, MHRA, WDA(H), WDA(H)

As Great Britain (GB) are no longer part of the European Union (EU) since the 1st of January 2021 exit date. It is essential to ensure all the necessary changes have been made to remain MHRA compliant.

Refrigerated Medicinal Products – what to consider…

Refrigerated Medicinal Products – what to consider…

by Sally Finlayson | Jul 13, 2021 | Blog, Export Training, Good Distribution Practice - GDP

How do you manage YOUR refrigerated medicinal products? Check out 10 key points to ensure you are shipping your products effectively

Toll Manufacturing or Contract Manufacturing which one should you choose?

Toll Manufacturing or Contract Manufacturing which one should you choose?

by Jackie (née Heneghan) Peck | Jun 11, 2021 | Blog

It is difficult to determine which process is better of the two- Toll Manufacturing or Contract Manufacturing.

What is a Stringent Regulatory Authority?

What is a Stringent Regulatory Authority?

by Jackie (née Heneghan) Peck | Jun 10, 2021 | Regulation

“Stringent Regulatory Authority or SRA” is a term that was developed by the WHO Secretariat and the Global Fund to Fight AIDS, Tuberculosis and Malaria.

Global crackdown of illicit medicines and medical devices

Global crackdown of illicit medicines and medical devices

by Sally Finlayson | Jun 8, 2021 | Blog, Cogent Gold Standard, GDP/RP, Training

The MHRA reported today on a global operation which took place at the end of May. See the full report here Co-ordinated by Interpol, the 14th “Operation Pangea” saw over 100 countries joining force. 3 Million illicit medicines were seized valued at £9...
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Recent Posts

  • Communication from the GPhC regarding Regulatory Concerns
  • Professional Indemnity Insurance
  • FDA Warning Letters

Upcoming Courses

  • GDP/RP Cogent Gold Standard Online Training on 16 September 2025
  • GDP Audit Online Training on 1 October 2025 10:00 am
  • Licence Holder Training on 14 October 2025 10:00 am
  • GDP/RP Cogent Gold Standard Online Training on 21 October 2025
  • Export Online Training on 6 November 2025

MHRA Alerts & Recalls

Field Safety Notices: 1 to 5 September 2025
9 September 2025
Class 4 Medicines Defect Notification: Hikma Farmacêutica, Gemcitabine 2g/52.6ml concentrate for solution for infusion, EL(25)A/43
4 September 2025
Profemur Cobalt Chrome Modular Neck Hip Replacements: Higher than anticipated risk of revision surgery, metal-wear effects and component fracture (DSI/2025/005)
4 September 2025
Field Safety Notices: 25 to 29 August 2025
3 September 2025

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