Batch Importation and Certification

Pharmaceutical Solutions holds a Manufacturer’s Authorisation (MIA(IMP) 29826) allowing the site to certify batches of Human Investigational Medicinal Products for phase I, II, III clinical trials operating in Great Britain (GB).

Pharmaceutical Solutions are licensed to certify, or import and certify, batches of the following dosage forms:

• Sterile Investigational Medicinal Products
  • Aseptically prepared batches of large volume liquids, lyophilisates, semi-solids, small volume liquids, solids and implants
  • Terminally sterilised batches of large volume liquids, semi-solids, small volume liquids, solids and implants
     
• Non-Sterile Investigational Medicinal Products
  • Hard shell and soft shell capsules
  • Chewing gums
  • Impregnated matrices
  • Liquids for internal or external use
  • Medicinal gases
  • Other solid dosage forms
  • Pressurised preparations
  • Semi-solids
  • Suppositories
  • Tablets
  • Transdermal patches
     
• Biological Investigational Medicinal Products
  • Biotechnology products
  • Human or animal extracted products

In addition, Pharmaceutical Solutions are licensed to import intermediates which undergo further processing.

Importation and certification of medicinal products is the end point of a process that gathers and assesses all of the information related to the product and the trial in order to provide the Qualified Person with confidence to certify the product. Pharmaceutical Solutions also provides this service, including an assessment of the product supply chain through audits.

Please contact us if you are interested in discussing Pharmaceutical Solutions' GB importation and/or certification services.

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