Validation Services
Quality Control (QC) of Biopharmaceuticals
The main responsibility of QC is to validate the manufacturing process and to oversee product quality control procedures.
In consequence, they are in charge of establishing and implementing validation and qualification operations, and hence follow a quality control program.
Chemically synthesized drugs can be characterized with precision and accuracy by widely accepted chemical and physical analytical methods. Differences between a reference listed drug and a generic drug can be easily determined.
Biopharmaceuticals, however, are complex macromolecules derived from recombinant DNA technology. Regarding the manufacture of biopharmaceuticals, the control of their quality, safety and efficacy in terms of “batch to batch” consistency is more complex and sophisticated.
Therefore, given the nature of biopharmaceuticals, it may be challenging to sufficiently characterize them. Product characterization and specifications (ICH Q6B) are essential GMP requirements to confirm product and process quality.
Product Characterization
The objective of product characterization is to contribute to a better knowledge of product-biology and structure-function relationships. The biotechnological product is characterized by its biological, physico- and immunochemical properties, and by purity and impurities.
The assessment of the biological properties, however, plays a major role in establishing a characterization profile. In defining the critical product quality, these properties add attributes and support product safety. Analyses are mandatory GMP requirements for release and marketing authorization.
Specifications
As full characterization of biopharmaceuticals is rather difficult to achieve, specifications are also chosen to confirm quality.
Specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria for the test described (ICH Q6B).
Specifications are considered as critical quality attributes and are part of the process validation. The manufacturer must propose and justify them, and regulatory authorities must approve them (ICH Q6B).
Our Validation Expertise
- Sound knowledge and proven hands-on experience with process validation, method validation, bioassays and computerized system validation
- Expertise in cleanroom validation (Annex 1)
- Expertise in setting specifications and defining acceptance criteria
- Knowledge of GMP requirements and regulations
Our Validation Services
- Process Validation
- Method Validation
- Bioassays
- Computerized System Validation (CSV)
- Supporting Gene Therapy Experiments
- Supporting Cleanroom Validation
- Technical Transfer of Test Methods
Your Benefits:
- Contributing to validated test methods and processes
- Contributing to cGMP compliant quality standards
- Contributing to GMP release
- Supporting Marketing Authorization
Definition of Validation
“Validation is a process of demonstrating, through documented evidence, that a process, procedure, method, piece of equipment, or facility will consistently produce a product or result that meets predetermined specifications and quality attributes.” (FDA)