ALS prides itself on providing a vast array of testing services for all your analytical and consulting needs.
Batch Release and Quality Control
Good Manufacturing Practice (GMP) for Medicinal Products requires batch release against the approved product specification, for medicinal products holding a marketing authorisation. Our QC batch release testing laboratories utilise a wide range of analytical technologies to provide responsive release testing using pharmacopoeial or client specific methods, confirming that products meet their specification. Routinely handling a diverse range of sample matrices leaves ALS well positioned to meet the needs of our clients' ever expanding product portfolios and diverse product ranges.
We are highly experienced in chemical and microbiological method validations across many techniques and product types.
We can assist throughout the entire process including project planning, protocol preparation, and analytical testing to final project report.
Key test method areas in which we have expertise include:
- Dissolution profile studies
- Compendial methodologies bespoke to your product formulation
- Stability indicating test methods to comply with ICH
At ALS we have a proven track record of delivering method development projects across a range of analytical methodologies.
We specialise in method development for HPLC, GC and ICP analysis.
Analytical Method Transfer (AMT)
Analytical Method Transfer (AMT) is performed as standard prior to conducting routine release testing in accordance with regulatory requirements.
Analytical method transfer is critical to ensure continuity of data and with our experience in performing this comparative testing we can assist you throughout the entire process; from protocol preparation including guidance on testing requirements and acceptance criteria, analytical testing to final transfer report.