Pharmaceutical Process Validation Services

Criticality/Risk assessment

PHarmOuts trainers can teach your employees the Risk/Criticality analysis and assist with determining the impact level of systems and equipment that make up Process Validation. The assessment is guided by the Risk Analysis, assessing the chances of detection and impact failure. It is documented in a matrix which indicates the level of qualification or validation recommended.

Our trainers will give your personnel the tools to deliver the following:

Validation Master Plan

Development of a Validation Master Plan (VMP) early in the validation activities is important to communicate the planned Validation activities to the necessary people in the organisation.

The VMP defines:

the approach
the systems and equipment validated
the number and format of the protocols
establishes the standards for acceptance criteria.

The Validation process

Validation includes the preparation of:

Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)

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

Design

PharmOut consultants can train your employees in developing the User Requirements Specification (URS), which is used as a basis for process design. From the URS the design process begins.

Cleaning Validation

Protocols for Qualification/Testing

PharmOut can coach your staff on developing templates and doing the testing. Or we can provide the resources to perform the testing and documentation, under your supervision.