Assurance for Product Quality and Compliance
At ProPharma Group, our life science consulting experts provide process validation services for the design, qualification, and continued verification of manufacturing processes that help clients maintain quality and compliance for cGMP regulated products.
Our global teams partner with you to ensure that each step of the validation process is properly mapped and executed. By working with our process validation experts, you can deliver the documented evidence needed to guarantee regulatory agencies that careful and systemic attention is applied and that your product meets the necessary quality attributes.
What is Process Validation?
FDA process validation guidance – The FDA’s definition of process validation: “the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product”.
An essential aspect of the FDA’s process validation guidance is the lifecycle concept. This approach follows the initial drug development processes as well as the formation of routine commercial production and commercial manufacturing, concluding with the discontinuity of the product.
Our Product Lifecycle Approach
Our process validation experts have vast knowledge in defining business models, authoring deliverables, and managing projects that require expertise relative to FDA 21 Part 210 and 211. They will also help to ensure adherence to pharmaceutical validation activity guidelines throughout your product lifecycle.
Stage 1 | Process Design
Defining the commercial manufacturing process based on knowledge gained during development and scale-up activities.
- Initial process design experiments do not necessarily need to conform to cGMP. This step should be based on the guidance of sound scientific foundations
- It is essential to follow good documentation practices. The studies that show an improvement of process understanding should be documented.
- Repeated testing at this phase, until the process fails, is not generally expected according to the guidelines of the FDA.
- The creation of process controls are required to ensure product quality, and also cover any variability in product. The FDA requires process controls to cover the examination of materials and equipment monitoring. Process control and monitoring is essential under the following circumstances:
- The product attribute is not easily detected or measured
- When products/intermediates are not well characterized.
Stage 2 | Process Qualification
Performing the necessary evaluations to determine if a process is capable of reproducible commercial manufacturing.
- Proper design of manufacturing facilities is necessary under cGMP requirements
- Choosing appropriate utility systems and equipment. Equipment and utilities should be chosen according to documented design specifications.
- Verify that systems and equipment will perform within the necessary specifications
- Process Performance Qualification (PPQ) should be conducted holistically with the qualified utilities, facilities, equipment and trained personnel associated with the manufacturing process. When possible, the FDA prescribes that objective measures such as statistical metrics should be utilized.
- Written protocols and expected outcomes are crucial to process validation during this phase. Manufacturing conditions, a sampling plans, required tests, and data collection are highly recommended forto be included in protocol descriptions
Process performance qualification should commence after it has been approved by all required departments, in addition to the quality assurance unit.
Stage 3 | Process Verification
Developing ongoing monitoring during production to verify that the process remains in a state of control.
- cGMP guidelines recommend developing procedures to gather and evaluate data relevant to product quality.
- Following cGMP principles and industry best practices are essential when determining variability
- FDA guidelines state that sampling and monitoring in this phase should continue at PPQ established levels until enough data is accumulated to make significant variability estimates
- The maintenance of the utilities, facilities, and equipment is also important during this phase
Keep Your Process Validation on Track
ProPharma Group’s product lifecycle approach towards process validation in pharmaceuticals and biotech helps you deliver optimal product quality by identifying the presence and degree of process variation and the impact variation has on the process efficiency and product quality. Minimizing the variation reduces risks and ensures a robust process that reliably produces quality product.
Don’t leave your validation process to chance. Contact our team of life science experts to learn how we can ensure the success of your process validation.