Qualification & Validation (Q&V)

Qualification & Validation (Q&V) activities are considered initial activities that applied in any of the cGMP facilities. PharMatrix can provide a high level of Qualification, Commissioning, and Validation support to our client, and this is applied by following high science and Risk-Based approaches that will in turn save time, cost, and increase compliance.
Our capabilities can be summarized with the following Q&V services:

• Setting the Validation and Qualification Master Plan (V/QMP), in addition to Validation Plans (VP’s)
• Building User Requirement Specifications (URS)
• Issuing the Risk Assessment Policies (RA)
• Issuing and implementing all types of Qualification and validation protocols
• Conducting mapping studies for warehouses, trucks, and chambers (hot & cold conditions)
• Risk-Based analyses for current project management, Commissioning and Qualification/Validation approach followed
• Conducting effective Computer system validation (CSV)
• Cleaning and Process Validation Support
• Supplier Audit and Qualification