Pharmaceutical Process Validation Services

Criticality / Risk Assessment

As scientists and engineers we can lead the Risk/Criticality Analysis and assist with determining the impact level of systems and equipment that make up Pharmaceutical Process Validation. This assessment is guided by a Risk Analysis, assessing the likelihood of detection and impact of failure, and documented in a matrix which indicates the level of qualification or validation recommended.

Development of a Validation Master Plan

A development of a Validation Master Plan (VMP) early in the validation activities is important to communicate the planned Validation activities to the organisation. Process Validation is the most critical element of any validation effort.

The VMP details the approach, defines the systems and equipment to be validated, sets out the number and format of the protocols and establishes the standards for acceptance criteria.

If a new item is to be purchased, a User Requirement Specification, URS, is essential.

Validation includes the preparation of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Qualification and Validation are integral steps in Quality by Design, building quality into any process or facility. PharmOut staff have years of experience to provide an efficient, effective, documented methodologies to ensure your process efficiencies, quality and compliance global regulations and guidelines.

It is essential as part of your process validation checklist for pharmaceutical manufacturing plants to plan and structure your activities.

PharmOut offers a proven approach validation, where the Validation begins with the identification of the critical control parameters, or quality and therefore business critical parameters which must be controlled.

Various GMP risk assessment techniques are used to assess the GMP risk.


PharmOut consultants can assist you in developing the User Requirements Specification (URS), which is used as a basis for process design. From the URS the design process begins. By using Quality-by-design principles, we then perform design reviews to determine the optimal design, ensuring that profitability and quality targets are met.

Protocols for Qualification/Testing

The boring bit that every Pharma professional dreads….

So, outsource it to PharmOut! We can either provide templates and do the testing on a fixed price basis. Or we can provide the resources to perform the testing & documentation, under your supervision.

To learn more:

Please contact us to discuss your needs.