EUGMP Services and Sub-Batching

Active Pharma Supplies ltd is a supplier of active pharmaceutical substances and excipients to clinical supply manufacturers including hospitals, licensed medical specials manufacturers, pharmacies, pharmaceutical manufacturers and food supplement manufactures.

Unlike other API distributors we are licensed as a manufacturer to pack and repack APIs into primary and secondary packaging by the MHRA to EUGMP and ICH Q7 guidelines. We can supply small packs of starting materials ideal for clinical supplies and small batch manufacturing.

Active Pharma Supplies Ltd operates to an EUGMP based Quality Management System. Active Pharma Supplies Ltd also offers a sub batching service only function, whereby material is supplied on a free issue basis. Our unique

We can repack bulk starting material including active pharmaceutical ingredients/ substances  (API) and excipients on a free issue basis to your packaging protocol.

Active Pharma Supplies Ltd can be used as a contractor to perform specific dispensing procedures on your bulk starting material, assuring that the material remains in specification.

We specialise in operations that avoid facility and equipment revalidation.

Projects.

  • Bulk starting material manufacturer requiring smaller packs for redistribution to customers.
  • Manufacturers of authorised medicinal products requiring active substance packaging reworking for the preliminary stages of batch production.
  • Reworking starting material pack sizes ready for terminal sterilisation.

Capabilities

  • Primary repackaging of powders, semi solids, liquids and high viscosity fluids.
  • Secondary repackaging of powders, semi solids, liquids and high viscosity fluids.
  • EU Class C / ISO Class 6 clean rooms.
  • EU Class B/ ISO Class 2 Laminar air flow cabinet.
  • Validatable heatsealing for terminal sterilisation,.
  • Class 1 isolator.
  • EUGMP validatable cleaning method development and implementation.
  • Rapid ISO Class 1 repacks requiring no cleaning validation, in sterile or non sterile isolators.
  • Sterile Isolator.
  • Non sterile isolator.
  • Time critical work.
  • Same day shipping to next site.
  • Liquid transfer including harsh and highly viscose material.