|
|
 |
GMP Dietary Supplements Services |
 |
 |
In June 2007, the FDA issued the Dietary Supplement CGMP Final Rule, 21 CFR Part 111. This final rule introduces requirements that, among other things, impact quality control operations, record keeping, and employee training related to the manufacturing, packaging, labeling, and holding of dietary supplements. Compliance dates are being phased in, depending on company size. If your company has 500 or more employees, you have been subject to these requirements since June 2008. In June 2009, companies with 21 to 499 employees will be obligated to be in compliance, with all companies subject to the new requirements by June 2010. |
|
| |
| Still less regulated than pharmaceutical companies, dietary supplement suppliers nonetheless must effect the necessary changes to avoid FDA action, financial penalties, and business disruption. Polaris can help your company identify with what is needed to be in compliance with FDA requirements, make recommendations on how to become compliant, and assist you in implementing your plan. |
| |
| Polaris’ services include: |
- Guidance to comply with the FDA deadlines in implementing 21 CFR Part 111
- SOP writing to comply with 21 CFR Part 111
- Training to comply with 21 CFR Part 111
- Consulting on issues in all phases of Manufacturing, QC laboratories, and Quality Assurance
- Mentoring staff in areas of Quality Assurance and 21 CFR Part 111 compliance
- Developing vendor certification programs, CAPA programs, and internal and external auditing
- Performing FDA Inspection Readiness audits
- Interfacing with the FDA’s regional and headquarters offices
|
|
|
|
200 Commonwealth Court, Suite 101 
