Identify the major impurities and specifications. Provide purity profile, along with detailed description of specifications and tests. Submit protocol and results upon completion. Verify lack of fungal growth. Provide protocol fo study and results upon completion.
Heat sealing process needs to be provided.
Assurance and verification needs to be provided that no decomposition or toxic components, that may contaminate product, are formed during heat-sealing. Justify the stability of cannabinoids under testing conditions. Any proposed expiration dates must be supported by data. At least three should be provided. Process validation, cleaning validation and rework procedural documents need to be provided.