Allay Consulting’s April Newsletter: Top 6 cGMP Nonconformances

Allay’s Top 6 cGMP Nonconformances

Spread the word: Marijuana and Hemp companies can receive cGMP certifications! cGMP certification is gaining more traction with the cannabis industry for many reasons – risk mitigation, gaining a competitive edge, and regulatory readiness. Current Good Manufacturing Practices (cGMP) are a set of standards that were created by the FDA and covers manufacturers of food, dietary supplements, cosmetics, medical devices, and pharmaceutical drugs. cGMP certification helps to ensure products are made consistently and reliably to product specifications for identity, strength, quality, and purity. Not only does cGMP help businesses limit hazards related to contamination or process controls risks, but also ensures that products are consistent and safe for consumers.

We previously covered trending violations within Colorado’s hemp industry and FDA, and this month we are covering Allay’s top current Good Manufacturing Practices (cGMP) nonconformances. As former cannabis regulators, Allay has both a regulator’s perspective and a consultant’s viewpoint when evaluating the compliance of a facility. Following trends provides more insight into our most common cGMP nonconformances we frequently see with our marijuana and hemp clients. This insight can help you to avoid some of the frequent nonconformances that other companies often fall victim to.

 

Which cGMP Nonconformances are Common?

We have compiled our most common cGMP nonconformances found during both marijuana and hemp cGMP audits. These common nonconformances were observed at facilities that included these kinds of processes: product handling, extraction, manufacturing, infusing, and packaging.

  • Approved Supplier Records: Vetting your suppliers is not just a good idea to reduce your liability, but it’s a cGMP requirement! Companies must have a written program that will qualify their suppliers of materials, ingredients, equipment, and services. This process assesses the supplier’s compliance, regulatory status, scope of their quality management system, and capability to consistently provide the desired material or service. Vetting suppliers helps ensure the supplier has controlled hazards in the supply chain control.
  • Traceability Program: All ingredients, primary packaging, and finished product must be tracked in a traceability program. Products shall be clearly identified for all stages of production from receival through to finished goods and shall be able to be traced forward to the consumer and traced back to the supplier. Having a strong traceability program supports a quick and less painful product recall experience.
  • Sanitation: The most tedious and crucial aspect of maintaining a compliant facility is sanitation! It is expected that sanitation efforts will remove/reduce pathogenic microorganisms in the facility. Documenting such verification and validation activities is imperative to the quality management system.
  • Environmental Monitoring: Companies must demonstrate adequate facility environmental sanitation process controls. Environmental monitoring evaluates the effectiveness of cleaning/sanitation procedures to verify that employees are manufacturing product in a sanitary environment.
  • Physical Facility: The facility must be constructed in a way to prevent entrance of pests, sealed, smooth and easily cleanable to not accumulate debris and sources of contamination. This includes all crevices and cracks shall be sealed, all window and door gaps closed, surfaces be non-porous, exposed piping protected, no wood, etc. Nonconformances at the physical facility also includes plumbing, required sinks, and production flow.
  • Training Records: Employers must document training of their staff on cGMP expectations. This could be in the form of in-person training, document review, power point, or combination of these into a singular approach. Collecting documentation and frequency of trainings for all employees and contractors is a requirement. In the auditor’s eyes, if it’s not documented – it never happened.

Need Support with cGMP Implementation?

Preventing nonconformances not only reduces your chance of receiving a nonconformance report, but more importantly protects your company from liability issues. Prevention is key to compliance success. We hope sharing our common cGMP nonconformances provides useful insight and an opportunity to learn from our experience. Allay Consulting compliance services work one-on-one with your company to create a realistic Quality Management System that is unique to your company’s production needs.

Contact Allay Consulting to learn more about implementing a cGMP system, written documentation, facility compliance, certification readiness, and employee education!

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