Safe Equipment and Systems
All parts of a production line that come into contact with drug substances or drug products must be designed, tested, and documented as not altering the safety or quality of the finished product.
SAXOCON provides you with everything you need to establish and document compliance with regulatory requirements for pharmaceutical manufacturing systems, including:
- The selection and characterisation of construction materials
- A risk analysis in accordance with European and US Pharmacopeia standards
- Extractables testing strategies
- A review of protocol and monitoring of extractable studies
- A toxicological risk assessment of results
Why choose us?
SAXOCON services for the manufacture of pharmaceutical products give you access to:
- A multidisciplinary team of highly skilled toxicologists, material scientists, and supply chain professionals
- Extensive experience in pharmaceutical product safety assessment
- Safety evaluations based on proprietary information obtained from our worldwide network of materials suppliers
- State-of-the-art solutions according to international standards and regulatory guidelines
- Smart, cost-effective test strategies that bring your products to market in a timely manner
SAXOCON compiles all necessary documentation in a written report for use in your Good Manufacturing Practice file.
EMA nitrosamine requirements.
Particulate matter screening.
Maintain GMP in relation to ICH Q7-9
Establish PDE for production.