PHARMACEUTICAL PRODUCTS BULK STORAGE AND LICENCE APPROVAL

AAH Pharmaceuticals lead the way in the UK as the number one specialist pharma products wholesale distributor and is continually developing its distribution model. Valcomm was appointed to help AAH obtain Medicines and Healthcare products Regulatory Agency (MHRA) approval for a new bulk product facility comprising of ambient warehousing, palletised bulk storage of refrigerated product and palletised bulk storage of Controlled Drugs.

After considering the possible solutions, an existing warehouse was adapted to suit the requirements. This required the adaptation of three dedicated areas:

  • Ambient product bulk storage
  • Refrigerated product bulk storage
  • Controlled Drugs bulk storage at ambient temperature

All products were required to be stored within pallet racking and therefore both the Controlled Drug Room and Cold Store were of significant size.

Valcomm applied its expertise to several aspects of the project including:

  • Consultants in the design phase of the storage areas
  • The supply and install of the independent monitoring system (IMS)
  • UKAS calibration of the IMS sensors
  • Formal qualification of the storage areas
  • Performance of mapping studies to verify the temperature stability of each area (including seasonal variance)
  • Presentation of qualification material within MHRA audits

Feedback from the MHRA audit was positive with final licence granted.

 


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