Be safe, compliant and efficient with state of the art cGMP pharmaceutical testing solutions.
As regulatory business requirements become increasingly complex, pharmaceutical manufacturers are finding it harder than ever to remain compliant. SGS’s advanced analytics solutions, aligned with the latest international regulatory standards, will help you to deliver high quality, safe and compliant products. With cGMP compliant laboratories using state-of-the-art technologies, we can detect ultra trace levels of leachables and nitrosamines at recommended LOD/LOQ levels and specifications.
Benefits of advanced analytics from SGS
- Avoid penalties for non-compliance
- Protect your brand’s reputation
- Ensure product quality and safety
- Protect the lives of customers and patients
Regulators require drug makers to ensure that they have put in place effective measures to ensure that their products and formulations are free of impurities like nitrosamine. SGS offers accurate testing to detect the presence of nitrosamines and help you ensure the safety of your drug products, raw materials and active pharmaceutical ingredients (APIs).
Extractables & Leachables
Drug manufacturers must demonstrate that no toxic or harmful materials migrate from packaging materials into a drug during its expected shelf life. It is also in their interest to ensure that potential leachables do not end up in finished drug products in single-use systems (SUS) and other consumables used in pharmaceutical production.
SGS can help. Our E&L services include:
- Analytical chemistry
- Consultancy E&L strategies
- Qualification services
- Extractables and leachables (container, medical Device, SUS)
- Leachables screening
- Method development and validation
- Stability studies
You Can Trust SGS
SGS is a world leader in testing, inspection and verification with over a hundred years’ worth of experience, a global network and unparalleled resources. When you choose SGS, you can be secure in knowing that we are the best choice to help you ensure quality, safety and compliance.
Reach out to our experts directly
Call +91 77 99 444 126