Validation

Oasis Validates

Making compliance with GMP and GLP easy


Oasis Test House Limited, with its exclusive validation division, Oasis Validates, offers its expertise to support you through the technical and regulatory issues associated with the analytical method validation and process validation. 

Oasis Validates provides offshore validation services for the pharma industry including those manufacturing companies, testing laboratories that do not presently have adequate technical personnel and/or time commitment to perform methods validation and process validation activities, in-house.

Outsourcing your analytical method validation and process validation activities will give you the freedom and time to focus your technical staff on its core competencies. Your investments in resources to develop and implement the requisite facilities for analytical method validation and process validation shall be reduced or eliminated.

Oasis Validates utilizes pooled resources of its organizations and affiliates, test houses and pharma manufacturing companies manned by scientists holding M.Pharm / Ph.D. with vast experience in analytical method validation and process validation. The strength of Oasis Validates is complemented through closed and formalized collaborative work with eminent scientists from reputed universities and institutions.

 

Oasis Validates offers following cost effective validation services at its exclusive validation lab:


Analytical Method Validation

Validation of the Analytical methods is a mandatory requirement as per Schedule L-I under Drugs and Cosmetics Rules. 

You are using various Standard Testing Procedures (STPs) / Analytical Methods to analyze your products manufactured at your own plant(s) or other’s plants / locations. The service offered by us includes:
  • Analytical Method Validation Protocol development
  • Analysis of validation samples
  • Analytical Method Validation Report


Pharmaceutical Process Validation

The service includes:
  • Preparation of process validation protocol
  • Guidance for execution of the process validation protocols, analyzing and interpreting the data collected based on the acceptance criteria
  • Preparation of final process validation report