What is GMP-Washing?
"GMP-washing" refers to the practice of misleadingly claiming compliance with Good Manufacturing Practices (GMP) standards without actually adhering to them. It involves presenting a façade of GMP compliance to regulators, customers, and other stakeholders while failing to meet the necessary requirements in practice. Here are some scenarios and examples of GMP-washing in the Cannabis and Industrial Hemp industry:
SOURCING NON-GMP INGREDIENTS AND FALSELY CLAIMING COMPLIANCE:
Unapproved Suppliers: companies may source raw materials from unapproved or uncertified suppliers to cut costs. These suppliers may not adhere to GMP standards in their manufacturing processes, leading to the production of substandard materials.
Lack of Quality Assurance: Non-GMP materials may lack the necessary quality controls, such as proper testing for purity, potency, and stability. Consequently, these materials may introduce impurities or contaminants into the manufacturing process, compromising the quality of the final product.
Repackaging and False Claims: After receiving non-GMP materials, the company may repackage them and falsely claim that they meet GMP standards. This deception may involve creating falsified documentation, such as certificates of analysis or supplier audits, to give the appearance of compliance with regulatory requirements.
Risk of Contamination: Non-GMP materials may be more prone to contamination with microorganisms, heavy metals, or other harmful substances due to inadequate quality controls. This poses a significant risk to consumer safety, as contaminated products can cause adverse reactions or illness.
INCOMPLETE DOCUMENTATION
Missing Process Steps: Critical steps in the manufacturing process, such as sterilization or purification procedures, may be skipped or undocumented, but falsified records indicate that they were completed as required.
Omission of Incidents: Incidents such as contamination events or deviations from standard operating procedures (SOPs) may go unreported or be inaccurately documented, giving the false impression of smooth operations.
Failure to Document Changes: Changes made to equipment, procedures, or formulations may not be properly documented or authorized, but records may be falsified to indicate compliance with change control procedures.
FAILURE TO MAINTAIN EQUIPMENT
Neglected Calibration: Equipment calibration schedules may not be adhered to, leading to inaccurate measurements or inconsistent product quality. However, falsified calibration records may indicate compliance with maintenance protocols.
Unreported Equipment Failures: Malfunctions or breakdowns of critical manufacturing equipment may occur but go unreported or be falsely documented as minor issues, masking the extent of the problem.
Bypassing Preventive Maintenance: Routine preventive maintenance tasks may be neglected, increasing the risk of equipment failure or contamination incidents. Nevertheless, falsified maintenance logs may suggest regular upkeep.
SUBSTANDARD INGREDIENTS
Counterfeit Raw Materials: Substandard or counterfeit raw materials may be used in manufacturing, compromising the quality and safety of the final product. However, falsified documentation may obscure the true origin and quality of the materials.
Adulterated Ingredients: Raw materials may be adulterated with impurities or contaminants due to poor sourcing or inadequate quality control measures. Nevertheless, falsified certificates of analysis may indicate compliance with purity standards.
Expired or Degraded Materials: Outdated or degraded raw materials may be used in production, resulting in inferior product quality. Nonetheless, falsified inventory records may conceal the use of expired or subpar materials.
These scenarios underscore the grave consequences of GMP-washing, particularly when companies prioritize cost-cutting measures over regulatory compliance and consumer safety. It highlights the need for robust oversight and enforcement of GMP standards to prevent such deceptive practices and safeguard public health.
Falsely claiming compliance with GMP standards while using non-GMP materials constitutes a serious regulatory violation. Regulatory agencies may impose severe penalties, including fines, product recalls, and legal action, against companies engaged in such deceptive practices. Consumers rely on Cannabis companies to prioritize product quality and safety. Discovering that a company has engaged in GMP-washing by sourcing non-GMP materials undermines trust in the integrity of the whole industry and can have long-lasting repercussions on reputation and consumer confidence.