The GMP/GDP Interface: When the Inspector comes

In the EU, GDP requirements and expectations are not only defined in the EU GDP Guidelines. The GMP Guidelines also have some paragraphs on storage and transportation, applicable for manufacturers of medicinal products. And GMP inspectors also look at these when inspecting manufacturing sites.

Earlier this year, the U.K. authority MHRA (Medicines and Healthcare Products Regulatory Agency) published some very interesting and comprehensive information in their GMP Inspection Deficiency Data Trend 2015, covering 303 GMP inspections performed in 2015.

As in the previous years, the management of storage areas causes concerns in some instances. Taking a closer view at the examples of the findings it becomes obvious that root cause analysis, impact assessment and associated actions are still challenging for many companies:

• Temperature Mapping: The temperature mapping of the facility and storage areas was deficient
• Approval: Mapping of the production and warehousing areas performed by the contractor had not been approved by the company
• Change Control: The configuration of the drug storage room had changed with no assessment of the potential impact on the validity of the temperature mapping of the area
• Sampling area: Room usage was not recorded and there was no record that the room was clean and clear prior to use