Guidance for the use of UK Stand Alone Contract Laboratories published

The Guidance for UK manufacturer's licence and manufacturer's authorisation (for investigational medicinal products) holders on the use of UK stand alone contract laboratories has been updated to provide clarification on the use of UK contract laboratories. It now clearly states that contract laboratories that meet the criteria to be inspected must be named on manufacturer's licences or manufacturer's authorisations.

The document

  • Defines a stand alone contract laboratory in relation to quality control testing of medicinal products.
  • Provides guidance as to when a contract laboratory must be named on a manufacturer's licence for relevant medicinal products for human and veterinary use and/or a manufacturer's authorisation for investigational medicinal products.
  • Is applicable to all manufacturing licence holders, i.e. import, export, herbals and specials.
  • Provides guidance as to when a contract laboratory is not required to be named on a manufacturer's licence or authorisation.
  • Outlines the MHRA's criteria for inspection of contract laboratories.

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