What is Good Manufacturing Practice Compliance?

cGMP (Current Good Manufacturing Practices) compliance for Hemp Manufacturers involves adhering to regulations outlined by the Food and Drug Administration (FDA) in 21 CFR Part 111, ensuring the quality, safety, and consistency of products classified as supplements, including hemp-derived products.

This includes sourcing, extraction, formulation, packaging, labeling, and storage. Robust quality control, documentation, and testing are essential for accurate labeling, contaminant-free products, and consistent potency.

Achieving GMP compliance demonstrates a commitment to high-quality, safe products, building consumer trust, and ensuring regulatory adherence. Being compliant helps navigate evolving regulations, positioning manufacturers as reputable players in the hemp industry. Maintaining cGMP compliance is crucial for providing transparent, reliable products and contributing to the growth and legitimacy of the hemp market.

Why Become cGMP Certified?

Federal / State Compliance

Ensure your hemp establishment meets FDA and regulatory requirements as per 21 CFR Part 111. Our comprehensive service helps you navigate the complexities of GMP regulations, minimizing the risk of penalties, product recalls, and legal complications. Demonstrating your unwavering commitment to compliance will secure your business’s long-term success and sustainability.

Robust Quality Assurance

Our expertise empowers you to implement robust quality control measures, effectively mitigating the risk of contaminants, guaranteeing manufacturing integrity, and maintaining unwavering potency. With our guidance, your products embody the pinnacle of safety and consistency, inspiring consumer trust and setting you apart in the competitive market.

Competitive Advantage

In today’s hemp industry, the demand for GMP-certified products is paramount. Set yourself apart by attaining a competitive edge through cGMP compliance, positioning your brand as an epitome of quality, safety, and regulatory excellence. Captivate customer attention, solidify your market position, and capture valuable market share.

cGMP Compliance and Certification Program

Our turnkey services standardize and certify our clients as compliant with rules set forth by The Food and Drug Administration (FDA) for Nutritional Supplements (including hemp products) based on 21 CFR Part 111.

Step 1: Initial Inquiry and Pre-Assessment

  • Submit an inquiry form through our website, providing essential details about your hemp establishment.
  • Our team promptly reviews your inquiry and conducts a pre-assessment to determine your eligibility for GMP certification.
  • We respond to your inquiry, sharing detailed information about our services, requirements, and pricing.

Step 2: Process / Documentation Review

  • We request relevant documentation from your establishment, including SOPs, quality control records, and manufacturing processes.

If some or no documentation is available, we will create them!

  • Our expert team thoroughly reviews your documentation and processes to assess compliance with GMP standards.

Step 3: GMP Implementation

  • We prepare a comprehensive audit report summarizing our initial findings and observations from our initial assessments.
  • The report includes details on non-compliance issues, deviations, or improvement areas.
  • Engaging in discussions with key personnel, we gain insights into your understanding and implementation of GMP principles.
  • We provide actionable steps to address identified gaps and implement a compliant environment.

Step 4: Virtual Audit Preparation

  • We schedule a convenient time for a virtual audit, ensuring minimal disruption to your operations.
  • Our team develops an audit plan outlining the scope, objectives, and areas to be covered during the virtual audit.
  • We provide you with an audit checklist or requirements and prepare your hemp establishment for the audit.

Step 5: Virtual cGMP Facilities Walkthrough Audit

  • Our auditors conduct a virtual audit using video conferencing software and screen sharing capabilities.
  • We review your GMP facilities, processes, equipment, and quality control procedures remotely, assessing compliance with GMP standards.
  • A passing score is >90%. If the score is below 90%, corrective action and a repeated audit will be required before certification.

Step 5: cGMP Certification and Ongoing Monitoring

  • We evaluate your overall compliance based on the virtual audit results and successful completion of corrective actions.
  • We issue the GMP certification to your hemp establishment upon meeting all requirements.
  • We establish an ongoing monitoring program, conducting regular virtual audits, inspections, or spot checks to ensure the maintenance of GMP compliance.

We will do it all for you! Leveraging our expertise and industry knowledge to help you achieve and maintain the highest standards of quality, compliance, and excellence in the hemp industry.

Average Time to Certify:
0
Days

Our Implementation Services

Gap Analysis & Compliance Assessment

Our team conducts a thorough evaluation of your existing processes and practices to identify gaps in meeting cGMP requirements. We provide a detailed report highlighting areas that require improvement or adjustment.

Standard Operating Procedures (SOPs)

We develop and refine SOPs tailored to your hemp establishment’s specific needs. These SOPs outline step-by-step instructions for each process, ensuring consistency and adherence to cGMP Standards.

Comprehensive Training & Education

We offer comprehensive training programs for your staff, covering cGMP principals, proper equipment and material handling, quality control measures, best practices, and more. Empower your team with the knowledge and skills necessary to meet cGMP requirements.

Documentation & Recordkeeping

We implement proper documentation practices, including batch records, logbooks, and recordkeeping procedures. Well-maintained documentation ensures traceability, facilitates audits and demonstrates compliance with cGMP requirements.

Audit & Compliance Support

Our experienced auditors provide regular audits and assessments to ensure ongoing compliance with cGMP standards. We identify areas for improvement, provide guidance on corrective actions, and support you in maintaining a state of audit readiness.

Process Validation

Our experts guide you through the process validation requirements to ensure that your manufacturing processes consistently produce high-quality hemp products. We help you develop protocols, conduct validation studies, and establish ongoing monitoring procedures.

Let's get Certified!