US Quality Certification provides facility focused services that help your facility become cGMP compliant. These services can include an initial Gap facility audit and cGMP certification facility audit. These services are tailored per client to address a wide range of needs from packaging to full facility certification and can range from one to three days of onsite evaluation. Identifying quality issues and providing recommended resolution plans will help you ensure the production of quality cannabis-related products. In addition to meeting, if not exceeding, current cGMP requirements, this service will help you proactively prepare for the anticipated federal and FDA approval of the product category, thus enhancing market positioning.
Services Include
Gap Audit
This service involves an abbreviated audit to evaluate your current manufacturing processes and to identify material deficiencies that must be addressed to get your facility ready for a full certification cGMP audit by a qualified USQC auditor. This audit requires remote preparation such as documentation review and a one-day, onsite audit.
These services include but are not limited to ensuring that appropriate SOPs are established for the following 6 GMP quality systems:
- Quality Management
- Facilities and Equipment
- Material Controls
- Production
- Packaging and Labeling
- Laboratory Controls
cGMP Audit
This service involves a thorough and complete audit of the program participant’s current manufacturing processes to help ensure full cGMP compliance. This audit may leverage Desk and Gap Audit findings and requires a two or three-day onsite evaluation. The length and intensity of the audit may be adjusted based on the size and activities performed at the facility and your specific needs. When full cGMP requirements are met, USQC will provide a certificate of cGMP compliance to post on the participant’s website and at their facility.
GMP Audit Services include but are not limited to:
- Two-day GMP audit: Primarily for those who are packaging products containing Cannabis (e.g., Hemp, CBD, THC)
- Full three (3)-day GMP audit: A3 day (depending on your needs) onsite audit for those who are manufacturing products containing Cannabis (e.g., Hemp, CBD, THC). Our GMP auditing services include:
- Vendor and supplier audits
- Risk assessment and risk mitigation plans
- Quality System and corporate SOP Analysis