Paradigm Shift

Auditing

The Real Costs of a WDA: What No One Tells You About Pricing in 2025
16 Oct 2025
The Real Costs of a WDA: What No One Tells You About Pricing in 2025

WDA(H) Application Costs: What Pharmacies & Pharmaceutical Distributors Need to Know (2025 Update)  In the world of...

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Closing Meetings: What to expect from the MHRA Inspector 
13 Aug 2025
Closing Meetings: What to expect from the MHRA Inspector 

A closing meeting overview following an MHRA GDP Inspection  A closing meeting following a third party, MHRA (Medicines...

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External (2nd Party) Audits: Their Importance
12 Aug 2025
External (2nd Party) Audits: Their Importance

External (2nd Party) Audits If you’re a UK wholesale distributor of medicinal products, maintaining compliance with Good...

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Audit Planning: Tips and Tricks
18 Jul 2025
Audit Planning: Tips and Tricks

Tips for Audit Planning   Whether you are performing a ‘First Party’ internal audit, otherwise known as a self-inspectio...

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1st and 2nd Party Audit Report and Follow-up
17 Jul 2025
1st and 2nd Party Audit Report and Follow-up

Producing an Audit Report: What Happens Next Once you have planned and performed a first party (internal) or second part...

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Self-inspections (First-Party Audits)
27 Oct 2023
Self-inspections (First-Party Audits)

These guidelines aim to ensure that the quality and integrity of medicines are maintained throughout the supply chain, f...

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What is a WDA (H) (Wholesale Distribution Authorisation)?
6 Oct 2023
What is a WDA (H) (Wholesale Distribution Authorisation)?

The purpose of the requirement to hold a WDA (H) is to ensure that the regulations and guidelines relating to the procur...

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Inspections and Audits
29 Nov 2021
Inspections and Audits

Inspections and audits are a crucial part of compliance. Do you know what to expect and what to do?

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Wholesale Dealer Licence Application
10 Jun 2014
Wholesale Dealer Licence Application

Do you know what is required for a Wholesale Dealer Licence Application?

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MHRA Email Alerts
2 Apr 2014
MHRA Email Alerts

You should be subscribed to receive all MHRA Email Alerts.

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Self Inspection / Self Audit
4 Mar 2014
Self Inspection / Self Audit

The MHRA regularly find that self inspections, which are required for GDP compliance, are either not carried out or ar...

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Assistance with MHRA Inspections and Pre-inspection audits
19 Feb 2014
Assistance with MHRA Inspections and Pre-inspection audits

Many companies choose to have audits performed by a third-party before an MHRA inspection.

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