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Human Error is Not the Root Cause!

Human Error is Not the Root Cause!

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...
Why GDP Matters to Pharmaceutical Wholesalers

Why GDP Matters to Pharmaceutical Wholesalers

The Importance of GDP Guidelines from Manufacture to Wholesale The quality and safety of medicines depend not only on how they are manufactured, but also on how they are distributed throughout the supply chain by pharmaceutical wholesale distributors, and this is...
Top Tips for Effective Transport Validation

Top Tips for Effective Transport Validation

Effective Transport Validation: 10 Top Tips Following on from our blog post relating to the “Transport Validation Exercises: A GDP Compliant Approach”, and as there are several elements of performing effective transport validation exercises, we thought it may be...
Temperature Mapping Top Tips: Medicinal Product Storage Areas

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 mapping exercise should be carried out on the storage area before use, under representative conditions.  Temperature monitoring equipment should be...
Essential Guide to MHRA GDP Audits & Inspections: Preparing for MHRA Compliance

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

GDP Audits & Inspections To Master GDP Audits conducted by the MHRA is to achieve a level of expertise and control that ensures seamless regulatory compliance and ensures patient safety, the ultimate goal of GDP activities!  MHRA Inspections are critical...