Pharmaceutical Process Validation Services

Criticality/risk assessment

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

Developing a 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 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.

The Validation process

Validation includes the preparation of:

Installation Qualification (IQ)
Operational Qualification (OQ)
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. They are an essential part of your process validation checklist for pharmaceutical manufacturing plants to plan and structure your activities.

PharmOut offers a proven approach validation. It begins with the identification of the critical control parameters which must be controlled.

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

Design

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.

Cleaning Validation

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.