Validation Services for Biotechnologicals and ATMPs
“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.” (Source FDA)
Quality control (QC) of biopharmaceuticals
The main responsibility of QC is to validate the manufacturing process and to oversee product quality procedures. In consequence, they are in charge of establishing and implementing validation and qualification operations, and hence following 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 quality attributes and support product safety. Analyses are mandatory GMP requirements for release and marketing authorization.
Specifications of biological products
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).
Regulatory requirements by FDA
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.