Unexpected Particulate Matter Findings
Sudden unexpected findings of particulate matter in, or in contact with, drug products are common in pharmaceutical production facilities. Good Manufacturing Practice (GMP) and proper risk management of product quality require identifying the root cause and evaluating the impact of findings on product safety. This knowledge can be crucial for deciding whether to release or recall affected product batches.
A pre-defined service level agreement (SLA) with SAXOCON provides a fast-track process with everything you need to analyse and evaluate the impact of deviations or non-conformances:
- Optimal stacking of activities ensures a 2-3 week lead time from discovery to completed toxicological risk assessment.
- SAXOCON has the expertise and laboratory capabilities to quickly and accurately identify the root cause of any findings
- Expert advice in sampling and risk mitigation
- Toxicological risk assessment
Why choose us?
SAXOCON services for the manufacture of pharmaceutical products give you access to:
- Extensive experience with state-of-the-art safety assessments of pharmaceutical products according to international standards and regulatory guidelines
- A multidisciplinary team of highly skilled scientists and experts
- Extensive expertise in measuring and characterising materials, including nanomaterials
SAXOCON compiles all necessary results and documents them in a toxicological risk statement.
EMA nitrosamine requirements.
Test and secure your equipment.
Maintain GMP in relation to ICH Q7-9
Establish PDE for production.