Process Validation
“Process Validation is the documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce an intermediate or API (active pharmaceutical ingredient) meeting its predetermined specifications and quality attributes.” (Quote ICH Q7)
Defined in guideline ICH Q7 “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”. ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)
GMP Compliance Consulting on Process Validation
The criticality of process validation
Because end-product testing of biotechnological-derived products is of limited practicality, the validation of the manufacturing process is demanding regarding the complexity of biopharmaceuticals and immunotherapies.
Objective of Process Validation
The objective of process validation is to ensure product quality, in terms of safety and efficacy, and that products are being consistently produced and controlled to the quality standard appropriate to their intended use and as required by regulatory authorities for GMP release (21 CFR 211.100 and 21 CFR 211.110).
Audits and Inspections
Manufacturing of medicinal products is subject to inspections by regulatory authorities. The manufacturer is responsible to perform and implement process validation. The European Medicines Agency (EMA) and FDA represent Guidelines on Process Validation.
Key Expertise
Our validation engineers at Stolley Engineering, who are well-qualified, have an understanding of biopharmaceutical science, critical process parameters (CPPs), critical quality attributes (CQAs) and the manufacturing process related to biopharmaceuticals and immunotherapies, allowing us to determine and define process specifications and their acceptance criteria.
On-site Services
- Validating Process Operations
- Contributing to Upstream and Downstream Operations
- Applying Microbiology and Hygiene Concepts
- Validating Aseptic Processes (Annex 1)
Key Benefits
We offer expertise in upstream and downstream operations, product and process specific. We contribute to critical in-process controls, validation parameters and their respective acceptance criteria, tests used and the extent of testing.
