GMP/GACP

GMP/GACP
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Good manufacturing practices and good agricultural and collection practices 

The APIS system of GMP/GACP features are drawn directly from our functional experience with the principles of Good Manufacturing Practices (GMP) and Good Agricultural Collection Practices (GACP). 

GMP is a system created and mandated by government agencies to regulate the production, verification and validation of drugs, food, cosmetics, and medical devices. This ensures that finished products are effective and safe for consumers. GMP systems include guidelines and directives that set the minimum standard for manufacturers to meet in their production processes.

GACP is conceptually similar to GMP practices. However, its application is primarily for agricultural products such as peppers, lettuces, tomatoes, cannabis, and other such crops during the growing and harvesting phases of production. The difference between GACP and GMP can be succinctly described as: if a plant is growing or being harvested – GACP practices apply. If a plant has been harvested and then moved on to a processing step, such as drying or packaging, then GMP principles apply. Many crops, primarily food, need only comply with GACP.

Within the APIS GMP/GACP system, there are five key benefits: 

  1. Risk Management
  2. Controlled Materials
  3. Sanitation/Cleaning
  4. Production Batch Record
  5. Recall System

Risk Management

Risk Management is a systematic process designed to coordinate, facilitate, and improve science-based decision making with respect to risk. The two key benefits of Risk Management are Risk Assessment and Risk Mitigation.

  • Risk Assessment is the comprehensive evaluation of risks and associated impacts to the consumer. It is a tool to identify and document hazards associated with a system or process
  • It is used to assess and evaluate the severity and probability of identified hazard – including determining how detectable a risk is. Risk Assessment permits the categorization or classification of risks according to criticality and probability
  • Risk Mitigation facilitates activities that reduce the severity of risk or the likelihood of risk. This ensures consumer safety, product quality, and Data Integrity

Controlled Materials

A functional system of ensuring Quality Control over input materials is a key necessity in a GMP system. A Quality Product can only be produced with Quality Materials – whether that is a key nutrient such as calcium or nitrogen, or a growing medium such as rockwool or soil.

Functional benefits of a Controlled Materials system include:

  • Utilizing approved suppliers via written specifications
  • Inspection and verification of incoming materials
  • Clear and precise labelling of controlled materials
  • Proper storage practices
  • Historical records which tie directly into a functional recall system

Sanitation/Cleaning

For facilities producing any agricultural-based products, a robust and clear system of sanitation and cleaning is mandatory. Every operation defines ‘clean’ or ‘sanitized’ differently – as do individuals. “It looks clean, therefore it must be clean” is not a truism. To eliminate confusion and create agreeable standards, a system of sanitation and cleaning provides clear definitions on what ‘clean’ means, operationally, while also providing for proper cleaning agents, written records of use, as well as training on the proper storage, mixing, and use of all cleaning agents.

Production Batch Record

A Production Batch Record (PBR) is the comprehensive history of the lifecycle of a product or a crop. Any and all inputs to the product (such as nutrients), machines used, rooms produced in, and even individuals associated with the product are documented in a verifiable chain of records. For some industries, such as the cannabis industry, a batch or lot of products cannot be released to market without such a system of documentation. This record permits review by a trained Quality Control Person who carefully examines the production history, ensuring no key quality or safety steps have been overlooked. However, even for producers of crops like peppers or tomatoes, a PBR provides for evidence of historical success or failure. With key parameters identified, KPIs can be effectively generated and quarter-over-quarter, year-over-year success or failure becomes a matter of analysis. This permits the process of continuous improvement to be implemented, leading to targetable success and the ultimate level of risk management.

Recall System

A functional system of recall exists for when the unthinkable happens – the need to remove products from the public realm or distribution channels. The ability to recall products correctly ensures a contaminated or low-quality, non-conforming batch never reaches the hands of the public – thus preserving a business’ reputation along with keeping people safe.

A Recall System is not simply a stand-alone function. Rather, it is the successful integration of all major components of a Quality Management System. When a non-conforming batch occurs to the extent recall is necessary, all historical documentation from the onboarding of controlled materials, to the Production Batch Record, to cleaning and sanitation procedures is examined. The Recall System itself ensures no shipped products are missed from recall, and accounts for their destruction.

The most powerful function of a Recall System is the ability to understand WHO was involved, WHEN the error took place, WHY that error took place, WHAT the precise problem was, and WHERE in the production or supply chain the problem occurred. This examination allows for permanent corrective measures to be put in place and operational uncertainty eliminated. Even if no recall ever takes place, suppliers and consumers alike trust producers who are prepared for the worst but continuously deliver the best.