Validation Services for Biopharmaceuticals and ATMPs
“Validation verifies through documented activities that a process, procedure, test method, process equipment, or process plant consistently produces a product or result that meets specified specifications and quality characteristics.”
Quality Control of Biopharmaceuticals
The main responsibility of quality control is to validate the manufacturing process and to oversee product quality procedures. The quality control unit is responsible for setting up and implementing validation and qualification operations and for carrying out a quality control program.
Chemically synthesized drugs can be characterized with precision and accuracy by widely accepted chemical and physical analytical methods.
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 fully 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 critical product quality, these properties add quality attributes and support product safety. Analyses are mandatory GMP requirements for release and marketing authorization according to ICH Q6B.
Specifications
Definitions
Specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria for the test described (Source ICH Q6B).
About Specifications
Considering the complexity of biopharmaceuticals and that full product characterization is rather difficult to achieve specifications are part of quality control. Specifications are critical quality characteristics proposed and justified by the manufacturer.
The objective of specifications is to ensure product and process quality in terms of consistency and compliance to good manufacturing practices (GMP). Specifications include data of product characterization studies, drug development and preclinical studies, clinical data and analytical procedures.
FDA Regulatory Requirements
21 CFR § 211.160 General requirements.
(a) The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. The requirements in this subpart shall be followed and shall be documented at the time of performance. Any deviation from the written specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms shall be recorded and justified.
(b) Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.
We are contributing to regulatory requirements for GMP release of samples according to customer’s needs and exigencies.
Our Validation Services
- Analytical Method Validation
- Bioassays
- Process Validation
- Cleanroom Validation (Annex 1)
- Statistical Analysis
- Computerized System Validation (CSV).
Your Validation Benefits
Our validation engineers, who are well-qualified, have an understanding of critical quality attributes, critical process parameters, analytical methods, process equipment and risk factors related to biopharmaceuticals and immunotherapies, allowing us to specify validation parameters and acceptance criteria to your validation strategy.