Validation

Validation programs management

Pharmatech provide services in compliance with European EMEA’s GMP and FDA’s cGMP requirements for  pharma and biopharma companies.
Validation programs management and excution for production and cleaning processes.

All validation activities should be planned. The key elements of a validation program should be clearly defined and documented in a validation master plan (VMP) or equivalent documents”

The Rules Governing Medicinal Products in the European Union – “Good manufacturing practices” – Annex # 15 – Final Version Qualification and Validation – July 2001

  • “It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations.
  • Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated.
  • A risk assessment approach should be used to determine the scope and extent of validation.”

The Rules Governing Medicinal Products in the European Union – “Good manufacturing practices” – Annex # 15 – Final Version Qualification and Validation – July 2001

Contact us

ITALIAN OFFICE

Via A. Pacinotti, 19 05100 - Terni, Italy
+39 075 9729017 / info@pharma-tech.it

 

CONTACT NAMES

Stefano Montagnoli - CEO
Mobile Phone: +39 335 8078512
Mail: stefano.montagnoli@pharma-tech.it

Sanesi Paolo - Technical Director
Mobile Phone:+39 348 3345859
Mail: paolo.sanesi@pharma-tech.it