Safe Equipment and Systems

All parts of a production line that come into contact with drug substances or drug products must be tested and documented to demonstrate that their design does not alter 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

Delivery

SAXOCON compiles all necessary documentation for you to receive a Good Manufacturing Practice file as a written report.

Related Services

Nitrosamine impurities

EMA nitrosamine requirements.

Unexpected findings

Particulate matter screening.

Change control

Maintain GMP in relation to ICH Q7-9

Cleaning validation

Establish PDE for production.