GMP Compliance and Why It’s Important
Cultured meat industry is magnifying its pace in pursuit of governmental regulatory approval to be fully established and recognized as a self-sufficient meat substitute. With Singapore becoming the first country to give regulatory go-ahead for a San-Francisco based ‘clean meat’ company Eat Just, the tone has been set for the industry, defining its growth potential for the upcoming years. In fact, Barclays has estimated the alternative meat industry to grow from current €11B to a whooping value of €110B by 2029, composing 9% of the 1.4 trillion global meat industry. Of note, this estimation does not only include cultured meats, but rather the industry as a whole, with niches like lab grown meat culture media production and other complimenting divisions taking a significant share in the estimation.
Nonetheless, the rapid growth of the lab-grown meat industry raises many safety, ethical and regulatory questions. How to effectively regulate such an industry remains a debated topic. Regulations in the food industry vary vastly by country. In this article, we will focus on the cell-cultured meat regulations and GMP tips which apply to the United States and European Economic Area.
In the US, the FDA is the main regulatory body for all food industries with the exception of meat and poultry, the responsibility for which is taken by the US Department of Agriculture Food Safety and Inspection Service (USDA–FSIS). FDA and USDA have created a formal agreement allowing these bodies to jointly regulate meat and poultry produce. Importantly, it was decided that cell-based meats are ‘meat and poultry’ products, and that the agencies will use biomedical expertise to regulate the initial phases of cell-based meat production, covering cell collection, development, proliferation and differentiation processes. Further stages of production and labeling are then regulated by USDA-FSIS.
In the EEA, the regulatory framework for cell-based meats has been in place since 1997 and has been recently amended in 2018. Here, either the GMO regulation or EU Novel Foods Regulation will oversee the industry depending on the original cell types used for cultivation.
Good Manufacturing Practices (GMP) compliance remains a constant in the regulatory compliance for cell-cultured meats. Lab-based meat companies have to ensure that their manufacturing pipeline incorporates such practices. Here, we review the main GMP compliance needed for a safe and efficient manufacturing process in the cultured meat industry:
1. Sanitary Food Plant and Equipment Design
The current GMP requirements state that the processing equipment used in the production of meat and poultry products should be of sanitary design. In order to comply with this requirement, producers of cell-based meat products must ensure that:
- Current equipment used for culturing, maintenance and storage of produce is cleanable down to microbiological level;
- The equipment and instrumentation used during the production process is easily accessible for third party inspections and maintenance, as well as for deep-cleaning and sanitation;
- The equipment used during production and manufacturing is self-draining, meaning that no liquid waste can be collected and accumulated within the instrument;
- All hollow areas in the equipment potentially susceptible to biological waste accumulation and contamination are properly sealed;
- All maintenance worked carried out on the equipment can be done in a hygienic manner, ensuring that all maintenance enclosures are hygienically designed;
- All lab equipment and instruments used during the production process must be hygienically compatible with the rest of the lab or manufacturing plant.
- Cleaning and sanitising protocols are properly maintained and accessible by third party inspections.
2. Prevention of Foodborne Pathogens
Prevention of pathogenic contamination is a GMP requirement which relates to any produce and manufacturing processes, including cell-cultured meat. The key aspect of these guidelines is their consistency and routine approach. It is highly recommended to integrate these practices in the production process from the get-go, as it will make it much easier to comply and tick all the boxes. These GMP requirements include simple hygiene rules as well as testing and analytical procedures:
- Contamination monitoring procedures must be carried out routinely though following pathogen monitoring protocol, which must be accessible to third party inspections and regulatory checks;
- All employees involved in the production of cell-based meat must comply with personal hygiene practices. These include effective and frequent hand washing techniques and PPE in accordance with culture-handling guidelines;
- Microbiological testing practices must be carried out routinely at every stage of the production where contamination is possible;
- Effective cleaning and disinfection techniques must be established for the whole facility, including instrumentation and maintenance equipment. A good practice would also be to conduct regular checks of cleaning quality.
- Carry out unexpected routine internal inspections to ensure that compliance guidelines are followed not only when the inspection is due but at all times.
3. Prevention of foreign material in cell-based products
The points such as poor employee hygiene, poorly maintained instrumentation, reagents and cultures and other incorrect production practices can lead to a risk of food contamination with foreign material that can be harmful to consumers. The following list of preventative measures minimises this risk and prepares for unforeseen situations:
- Collaborating with external suppliers of raw materials or reagents, request letter of certification and guarantee from vendors. These will be handy when completing a regulatory check as well as in case of consumer emergencies;
- Employee education and training for handling cell-based products and carrying out production works;
- Ensure minimal contact and interaction between varying pieces of machinery and instrumentation. This can prove very difficult in bioreactor facilities in cell-based meat processing, and integrating this into initial workflows will save time and reduce costs.
- Ensure proper storage, shipping and receiving practices with all of the raw materials and reagents and prepare protocols for regulatory checks.
4. Labeling and packaging
Dealing with cell-based meat requires special attention to packaging and labeling of a product. FDA and USDA-FSIS. US officials have publicly stated that in addition to labeling regulations that apply to slaughter-based meat packaging, cell-based meats must be identified as ‘cell-based’, ‘cultivated’ or ‘cell-cultured’. This statement has not yet been made official, however, we recommend the producers to keep an eye out for the development of this topic. The standard practices for FDA-approved labeling and packaging include:
Employee training on correct packaging and labeling techniques across all manufacturing stages;
On-site audits of packaging and labeling compliance;
Established workflow for the verification of labels and packaging using tools such as barcode scanners and identification numbers;
Routine checks for cross-contamination of allergens to avoid omittance of potential allergens from the label;
Independent and internal audits of material suppliers which can include cell media, tissue, cell culture and reagent suppliers.
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