GMP compliant Validation Services – Pharma and Biotech
Validation verifies through documented activities that a process, procedure, test method, process equipment, or process plant consistently produces a product or result that meets defined specifications and quality characteristics.
Why Quality Control?
The main responsibility of the quality control unit 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.
Quality Control of Biologicals?
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.
Key Activities
Process Validation
- We contribute expertise and hands-on experience to process validation studies, product characterization, specifications and quality control activities.
Analytical Method Validation
- We specialize in the development and validation of analytical method validation according to ICH Q2 (R2).
Bioassays
- We specialize in the development and validation of cell-based Bioassays to determine the bioactivity and relative potency.
Cleanroom Validation
- We contribute expertise and hands-on experience with environmental monitoring, qualification operations, and hygiene concepts for aseptic processing (Annex 1).
Computerized System Validation
- We contribute expertise and hands-on experience with CSV.
Statistical Analysis
- We contribute expertise and hands-on experience with statistical analysis e.g. linear regression model, four parameter logistic regression model and other evaluations.
We are contributing to regulatory requirements for GMP release of samples according to customer’s needs and exigencies.
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.
Hands-on Experience
Our Validation Engineers at Stolley Engineering hold hands-on experience with process equipment, process validation, analytical method validation and instrument qualification. We are well-qualified and have the ability to interpret regulations and apply them to the validation studies according to international regulations.
