Manufacturing of Biotechnological Products 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.”
GMP Regulations and Guidelines
- ICH Quality Guidelines
- EU GMP Guide
- FDA 21 CFR 210/211
- EU GMP Vol. 4 Annex 15
- USP <1058> Analytical Instrument Qualification
- USP <1220> Analytical Procedure Lifecycle
- Eurachem Guide: Analytical Equipment and System Qualification
- EU GMP Vol. 4 Annex 11
- FDA 21 CFR Part 11
Quality Control of Biotechnological Products in compliance with ICH Q6B
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.
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.
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.
On-site Validation Services
- Analytical Method Validation
- Bioassays
- Process Validation
- Cleanroom Validation (Annex 1)
- Statistical Analysis
- Computerized System Validation (CSV)
Our Validation Engineers at Stolley Engineering hold hands-on experience with analytical instrument, process equipment and system qualification. They are well-qualified and have the ability to interpret regulations and apply them to the validation studies according to international regulations.
We have an understanding of critical quality attributes, critical process parameters, risk factors and quality control activities related to biopharmaceuticals, and cell and gene therapy (ATMPs) allowing us to contribute to your validation operations.
