Potent Compound Safety Program Design Services
Whether you are just getting started, or need to revamp a former potent compound safety program, the experts at Affygility Solutions can design and implement a potent compound safety program that will meet your company's unique needs.
Program elements may include:
- Facility design criteria
- Potent compound safety categorization schemes
- Risk assessment procedures
- Control banding criteria
- Containment validation and surrogate monitoring
- Industrial hygiene monitoring for active pharmaceutical ingredients
- Occupational exposure limits for active pharmaceutical ingredients
- Material safety data sheet creation and maintenance
- Medical surveillance programs
- Reproductive hazard programs
- Potent compound safety training programs (either online or onsite)
- Personal protective equipment programs, including respiratory protection programs
Our potent compound safety program design process typically starts off by conducting an on-site gap assessment. The purpose of the gap assessment is as follows:
- Become familiar your company's operations and products
- Determine what environmental, health and safety programs that may already be in place
- Determine the specific areas of greatest risk
Once the gap assessment has been completed, we will work with you in developing and implementing an action plan.
The experts at Affygility Solutions have years of potent compound safety experience. Our clients include contract manufacturers, contract research organizations, biotechnology companies, medical device, and pharmaceutical companies of all sizes.
In addition to the gap assessment, we can optionally help you implement Affygility Solutions' proprietary Affytrac compliance management software to ensure that your potent compound safety program is sustainable.