QUALITY ASSURANCE = SURPASSED EXPECTATIONS
Accupac has taken Quality Assurance (QA) to new levels for our customers—the world’s largest pharmaceutical companies.
- A FDA and cGMP regulated environment
- Our QA presence, which follows your project from inception to completion</li>
Accupac is compliant with FDA regulations for drug products and medical devices (21 CFR 211 & 21 CFR 820), as well as Annex V and ISO 13485. We also adhere to all customer corporate quality requirements.
Our team includes top chemists, microbiologists, lab technicians, QC inspectors, project engineers, validation technicians and regulatory compliance specialists. Working within a cGMP environment, they ensure FDA guidelines are met. The team clarifies requirements, secures specifications and takes pride in exceeding your expectations.
Our expanded state-of-the-art analytical and microbiological laboratories include:
- A wide range of physical and analytical testing capabilities
- In-house Stability Chamber: Stability management, testing services and in-house storage
- Validation services, including protocol preparation, tracking, execution, testing and final report generation
- Statistical process controls and statistical quality controls to ensure uniformity and consistency
- Annual product reviews
You get the added assurance of on-site testing and monitoring or our air and water systems. Any Accupac employee who comes in contact with your product has received the appropriate and documented training.
Accupac prevents problems and improves processes by analyzing statistical data and trends and we recommend action when needed. These benchmarks allow us to maintain and improve strict product parameters. We bring you cost-effective and responsive service through the diligence of our experienced lab services team.
That is how Accupac has become the leader in liquid contract manufacturing. We know you rely on our stability – especially when it comes to quality assurance.