Batch release testing
Batch testing is a critical process in pharmaceutical manufacturing, designed to confirm that every batch of drug substance or drug product meets stringent quality, safety and regulatory standards before reaching patients.
Robust analytical control for compliant batch release
At Quality Assistance, we provide fully integrated GMP analytical testing for drug substances, drug products, excipients and raw materials. From in-process controls to (non-)clinical and commercial batches, our commitment is to deliver compliant, reliable and traceable analytical data that support your release decisions and regulatory submissions. All our testing activities are performed according to transferred or validated methods, fully aligned with EMA, FDA and ICH guidelines.
Quality Control release expertise
We ensure the highest standards of product quality through rigorous QC release testing. Our approach is designed so that every batch of your product meets the highest standards of safety and quality, and predefined acceptance criteria before reaching patients.
Our analytical services cover the full spectrum of Quality Control testing, including:
- Physico-chemical, biological and microbiological assays
- Identity, purity and potency testing
- Impurity profiling (including genotoxic, process-related and product-related impurities/variants)
- Container Closure Integrity Testing (CCIT)
- Stability studies and storage of retained samples
We offer tailored solutions for GMP analytical batch release testing and analyse hundreds of QC samples per year.
We cover the full spectrum of batch categories, including non-GMP, toxicology, GMP and PPQ batches, up to commercial batch release. All testings are performed according to transferred or customised methods developed and validated in-house, ensuring robustness, reproducibility and regulatory compliance. Our services also include compendial testing in accordance with international regulatory expectations.
Related analytical techniques
Infrastructure and data integrity
All activities are managed within our integrated Quality Management System and supported by an in-house LIMS, ensuring complete traceability of samples, materials, instruments, data and documentation.
Our single-site structure enables harmonised procedures, robust data integrity and efficient project coordination.
Our laboratories are regularly audited and operate under established deviation, OOS/OOT management, CAPA and change control processes.
Related CMC services
Your trusted partner for QC batch testing
- Lot-by-Lot testing: every batch undergoes comprehensive testing to confirm product quality before release
- Complete test panel: a full range of analytical tests ensures that all critical quality attributes are met
- Validated methods: tests are performed using pharmacopeial methods or internally developed procedures that are fully qualified or validated
- Strict compliance with specifications: all results must meet predefined specifications. Any deviation is managed under OOS/OOT procedures
- Qualified Person oversight: analytical test results are reviewed and released exclusively by Qualified Persons, ensuring integrity and reliability in accordance with GMP regulations
Your trusted partner for batch release testing
Define the optimal QC release strategy for your clinical or commercial batches
Speak with our experts to streamline your QC release and documentation.
Get in touch with our team