Paradigm Shift

Deficiencies

Top Tips for Effective Transport Validation
8 Aug 2025
Top Tips for Effective Transport Validation

Effective Transport Validation: 10 Top Tips Following on from our blog post relating to the “Transport Validation Exer...

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Temperature Mapping Top Tips: Medicinal Product Storage Areas
8 Aug 2025
Temperature Mapping Top Tips: Medicinal Product Storage Areas

Temperature Mapping: What the Regulations Say Chapter 3.2.1 of the EU GDP Guidelines dictates: “An initial temperature ...

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Essential Guide to MHRA GDP Audits & Inspections: Preparing for MHRA Compliance
13 Mar 2025
Essential Guide to MHRA GDP Audits & Inspections: Preparing for MHRA Compliance

Don't let common GDP audit findings derail your compliance efforts. Discover proactive strategies to anticipate and addr...

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Documentation to GDP Compliance
11 Apr 2024
Documentation to GDP Compliance

Documentation is an essential part of GDP, as it provides evidence of the actions taken by the distributor to demonstrat...

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What is Change Control in Good Distribution Practice (GDP?
11 Apr 2024
What is Change Control in Good Distribution Practice (GDP?

Change control in GDP is a process used to manage any changes that may affect the compliance with Good Distribution Prac...

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What is a QMS (Quality Management System)?
11 Apr 2024
What is a QMS (Quality Management System)?

In the pharmaceutical industry, a QMS is essential to comply with the regulatory requirements and standards for the manu...

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Customer Service Complaints in GDP
11 Apr 2024
Customer Service Complaints in GDP

Complaints can indicate serious quality issues, regulatory breaches, or customer dissatisfaction. They are inevitable in...

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Medicinal Product Recalls: What, Why and How
11 Apr 2024
Medicinal Product Recalls: What, Why and How

A medicinal product recall is a process of removing or correcting a defective or unsafe medicinal product from the marke...

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Data Integrity Compliance in GDP
11 Apr 2024
Data Integrity Compliance in GDP

Data integrity is the degree to which data is complete, consistent, accurate, trustworthy and reliable, and that these c...

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What is Quarantine in Good Distribution Practice?
11 Apr 2024
What is Quarantine in Good Distribution Practice?

According to the EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use, it’s “…the status of s...

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GDP for RPs and Management Webinar
27 Apr 2023
GDP for RPs and Management Webinar

Our monthly GDP Webinar for RPs and Management is a popular event. Book now!

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WDA Suspended, Terminated, Cancelled, and Revoked: What do these terms mean?
20 Jun 2022
WDA Suspended, Terminated, Cancelled, and Revoked: What do these terms mean?

A suspended license can be fatal for a business of any size. Learn about the terminologies used here.

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