cGMP Drug & Raw Material Lot Release Testing
Pharmaceutical lot and batch release testing is an ongoing critical aspect of drug development, from early-stage through commercial batch release. As a key component of the quality control process, release testing is necessary to ensure biopharmaceutical drug substances, drug products, raw materials and in-process materials meet established specifications prior to final product release. These established specifications are necessary to confirm identity, purity, and potency, as well as to demonstrate that the product is in compliance with applicable requirements found in the Current Good Manufacturing Practices (cGMP) for drugs, per 21 CFR Parts 210 and 211.
Biopharmaceutical Raw Material Release Testing – Before any raw material or active pharmaceutical ingredient (API) can be used for manufacturing, it must meet the requirements outlined in 21 CFR 211.84. Raw material testing confirms the identity and integrity of the material, ensuring the correct product has been received and that it meets established specifications for its intended use.
Avomeen’s raw material testing supports early-stage drug development through commercial manufacturing, including characterization and specification testing for the release of excipients and APIs used in finished drug product manufacturing and vendor qualification. Identification of raw materials is performed by advanced analytical techniques and instrumentation including fast identification methods such as Raman spectroscopy. These fast ID confirmations at the receiving site can significantly reduce testing cycle time. Our expert scientists can verify monograph methods or develop and validate alternative raw material release methods.
In-Process & Pharmaceutical Batch Release Testing – Our rigorous analytical testing ensures that batches of manufactured drug products meet established quality standards and GMP requirements prior to releasing manufactured product lots. At Avomeen’s GMP facility, our scientists provide a comprehensive quality control lot release testing programs that meet each clients’ individual needs and specifications for their biopharmaceutical products. Our regulatory experts follow compendial methods when available, and client-provided methods can be transferred, verified, and optimized. Otherwise, alternate/new test methods can be developed and validated by our knowledgeable team.
Our batch release testing solutions apply to all stages of manufacturing, including revalidation and in-process testing needs. When a new process is initiated, equipment is changed, or a formulation is modified, pharmaceutical process validation testing (revalidation) is required. Avomeen’s consultative expert scientists have a proven track record of providing precise and expedient results for in-process testing and process validation, as well as lot release testing in our GMP labs.
Proven success developing, validating, and transferring sophisticated, complex, and challenging analytical methods.
Flexible protocols and study designs that include thorough chemical and material property testing in our GMP facility.
Consultative scientists well-versed in regulatory guidance, advanced analytical technology, and interpretation of data for developing product specifications.
Pharmaceutical Lot & Batch Release Testing Programs and Experience
We work with our partners to tailor our release testing programs to their specific requirements and needs, from simple tests to advanced, specialized techniques. We employ a wide range of technologies and instrumentation to provide comprehensive release testing for all types of biopharmaceutical drug substances, raw materials, APIs, and finished pharmaceutical products.
Raw material & finished product release testing includes:
- Compendial/Pharmacopeia testing (USP, NF, EP and BP)
- Physical and chemical analysis
- Formulation verification
- Potency and purity
- Impurity testing
- Related substances
- Particulate matter
- Limit tests
- Heavy metals
- Residual solvents
- Container-Closure qualifications
Experience with various sample matrices:
- Powders and granules
- Oral and topical liquids
- Creams, ointments and gels
- Oligonucleotides and biologics
- Combination products
Complete cGMP Lot Release Testing and Support
Our regulatory and industry experts ensure that every client receives the Avomeen standard of regulatory guidance that has helped countless organizations bring revolutionary drug products and therapeutics to market, while meeting both specifications and timelines for lot or batch release and distribution. Our full-service solution includes reference standard characterization and management. Get in touch with an expert to explore a partnership with Avomeen.