It’s not just drug, medical device, and bio-tech companies that are keeping their operations GMP compliant. Manufacturers of legal Cannabis and CBD related products are joining their ranks and progressing quickly. As the industry matures, companies are getting their plans and procedures in place for compliance and generating the documentation and systems that will be critical to meeting the requirements.
At their core, GMPs are, in fact, “Good Manufacturing Practices” and will help any company to improve the quality and consistency of their product. Aside from the regulatory requirements, it’s just good business.
Sebald Consulting is reaching out to Cannabis and CBD manufacturers to provide services to assist in this transition toward continuous improvement and compliance. Services include, but are not limited to, the following:
- Gap Analysis to identify areas of improvement with GMP compliance
- Development of Validation Master Plans (VMPs), Standard Operating Procedures (SOPs), Validation Protocols, and System Life Cycles as appropriate based on documented Risk Assessments
- Addressing data integrity issues including 21CFR11 compliance
- Commissioning and validation of equipment and systems, including computer system validation (CSV)
- Implementing calibration, maintenance, and validation programs
- Advising on equipment, control systems, and software that can improve outcomes scaled to the size of your operation
- Assisting in the implementation of these and other changes as necessary to improve compliance
A well designed compliance system can really help a company improve efficiency of operations and consistency of product, by reducing equipment breakdowns, improving measurement accuracy, and providing traceability. Please contact us for further information if we can help!