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Strengthening your QMS with Quality Risk Management

Strengthening your QMS with Quality Risk Management

by | 15 Jun 2026 | ALCOA, Auditing, Closing Meetings, Deficiencies, Deviations, Good Distribution Practice, Industry, MHRA, Pest Control, QMS, Qualification and Validation, responsible person, Risk Management, Root Cause Analysis, Standard Operating Procedures, Temperature Control, Training

Integrating your Quality Risk Management into your QMS Quality Risk Management (QRM) is not just a “nice-to-have” in Good Distribution Practice (GDP), it is a minimum expectation rooted in National law, guidance, and best practice. When applied correctly...
Managing Deviations with Confidence: Essential Insights into GDP Compliance

Managing Deviations with Confidence: Essential Insights into GDP Compliance

by | 29 May 2026 | ALCOA, Auditing, Deficiencies, Deviations, GDP Training, Good Distribution Practice, Premises / Facilities, QMS, Qualification and Validation, responsible person, Risk Management, Root Cause Analysis, Temperature Control, Training

Confidence in GDP Deviation Control Ensuring adherence to Good Distribution Practice (GDP) is fundamental to maintaining product quality, legal compliance, and, ultimately, patient safety. When everyday activities on a licensed distribution site become complacent or...
What Are the Main Elements of GDP Guidelines in 2026?

What Are the Main Elements of GDP Guidelines in 2026?

by | 27 Apr 2026 | ALCOA, Auditing, Consultation, Deficiencies, Deviations, GDP Training, Good Distribution Practice, Medicine, MHRA, Qualification and Validation, Risk Management, Shipping and Transport, Standard Operating Procedures, Temperature Control, Training

GDP Guidelines: The Main Elements The GDP guidelines (Good Distribution Practice) for medicinal products consist of ten working chapters and two annexes, which cover the following topics: Chapter 1 – Quality Management We start the GDP guidelines with describing...
Do Pharmacies Need a WDA? (2026)

Do Pharmacies Need a WDA? (2026)

by | 26 Feb 2026 | Auditing, Consultation, Good Distribution Practice, Import and Export, Industry, Medicine, MHRA, Pharmacies, Qualification and Validation, WDA, WDA Licence

What Pharmacies Need to Know Now About WDA(H): A Full Guide for 2026 Supply chains in pharmacies have tightened significantly since the days of the “5% rule.” If you’re a pharmacy owner, superintendent pharmacist, or part of a hospital or community pharmacy, it’s...
Application for a Wholesale Distribution Authorisation in 2026

Application for a Wholesale Distribution Authorisation in 2026

by | 5 Jan 2026 | Auditing, Consultation, Good Distribution Practice, Import and Export, Industry, MHRA, Qualification and Validation, Risk Management, Shipping and Transport, Standard Operating Procedures, Temperature Control, WDA, WDA Licence

The team at Paradigm Shift are often asked what the Wholesale Distribution Authorisation application process is. Whilst we have written about this subject in the past (Wholesale Dealers’ Application  and Wholesale Distribution Authorisation Explained), we...
Human Error is Not the Root Cause!

Human Error is Not the Root Cause!

by | 5 Jan 2026 | ALCOA, Auditing, Deficiencies, Deviations, GDP Training, Good Distribution Practice, Risk Management, Root Cause Analysis, Standard Operating Procedures, Training

Strengthening Root Cause Analysis (RCA) in GDP At a time when the Medicines and Healthcare products Regulatory Agency (MHRA) continues to highlight deficiencies in deviation investigations, one thing is clear… effective root cause analysis is essential for compliance...