Eisai Ltd

Eisai Ltd is one of the leading research-based Pharma companies in the world, and in recent years has expanded their presence in the UK. This included a new High Potency Packaging Facility in Hertfordshire, and The GMP Group were required to assist with the Validation of the new site.

Eisai

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Brief:

GMPG were employed to carry out all CQV works for a new, high-potency packing facility. The site team were responsible for compliance advice throughout the project, in particular any containment issues pertaining to the high-potency product.

 

What we did:

The GMP Group worked with Eisai's team to create a Validation Strategy, inclusive of:

  • VMPs
  • Validation impact assessments
  • Validation trace matrix
  • DQ, IQ, OQ and PQ protocol creation and exection
  • Qualification reporting
  • Project compliance
  • Technical support

 

Result:

The project was completed on time and to budget, with client dates for the first product validation batches being acheived. 

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Cert no. 11289

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Cert no. 11289