Assurance for Product Quality and Compliance
At ProPharma Group, we provide process validation services for design, qualification, and continued verification that help clients maintain quality and compliance for cGMP regulated products.
Our global teams partner with you to ensure each step is validated. You can deliver the documented evidence needed to guarantee regulatory agencies that careful and systemic attention is applied and your product meets necessary quality attributes.
Our Product Lifecycle Approach
Our experts have vast knowledge in defining business models, authoring deliverables, and managing projects that require expertise relative to FDA 21 Part 210 and 211, and help ensure adherence to validation activity guidelines throughout your product lifecycle, including:
- Stage 1 – Process Design: Defining the commercial manufacturing process based on knowledge gained during development and scale-up activities.
- Stage 2 – Process Qualification: Performing the necessary evaluations to determine if a process is capable of reproducible commercial manufacturing.
- Stage 3 – Continued Process Verification: Developing ongoing assurances during production that the process remains in a state of control.
Our qualified approach towards process validation in pharmaceuticals, biotech, and medical device manufacturing helps you deliver quality attributes. We will detect the presence and degree of variation, understand the impact of variation on the process and ultimately on product attributes, and control the variation in a manner commensurate with the risk it represents to the process and product.