Product/Service

VWS Validation Package

Source: Crown Solutions, A Veolia Water Solutions & Technologies Company
The VWS validation package covers all the needs required for the successful qualification of your water treatment system to meet the needs of both the manufacturer and the inspection bodies such as the FDA and MCA.

Click Here To Download:
•Product Brochure: Pharmaceutical Water Solutions

Veolia Water Solutions & Technologies (VWS) is widely recognized as the leading supplier of validated water treatment systems for the pharmaceutical industry, specializing in the design installation, commissioning and validation of purified water systems.

The VWS validation documentation package has been developed by a dedicated team of validation engineers with first hand knowledge and experience acquired over many years of working directly with the major pharmaceutical companies, leading consultants and contractors. This documentation package has been adopted by Crown Solutions.

The VWS validation package covers all the needs required for the successful qualification of your water treatment system to meet the needs of both the manufacturer and the inspection bodies such as the FDA and MCA.

The documentation package follows the various regimes, protocols and guidelines laid out by the regulatory authorities and the industry bodies:

  • USP, EP, JP – the water standards in the pharmacopoeia
  • 'Good Manufacturing Practice' (GMP)
  • FDA Code of Federal Regulations 21CFR210 & 21CFR211
  • 'The Rules Governing Medicinal Products in the European Union' Volume 4
  • ISPE 'Baseline Guide' on Water and Steam,
  • US regulation 21CFR11 Electronic records and electronic signatures
  • 'GAMP 4' – a guideline for the validation of automated systems
  • ISO 9001 – Quality Management System approval by LRQA
Crown Solutions, a VWS subsidiary, follows these standards when designing water treatment systems for the pharmaceutical industry. We have been regularly audited by a number of leading pharmaceutical companies and consultants and have satisfied the auditors with regards to all aspects of compliance.

The documentation supplied enables a smooth progression through the validation trail to include the Design Qualification (DQ), Installation Qualification (IQ) and Operational Qualification (OQ) and then allow you to successfully complete the Performance Qualification (PQ).

On site execution of the validation of the water treatment plant (the detailed IQ and OQ process) is carried out by Crown Solutions' team of fully-trained Commissioning & Service Engineers. This is carried out in the presence of your validation and maintenance engineers to confirm the integrity and operability of the water treatment system.

Our engineer will fully commission the water system and then train the on-site maintenance personnel in the ongoing operation and maintenance of the system to comply with the training requirements of GMP.

Click Here To Download:
•Product Brochure: Pharmaceutical Water Solutions