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Author:Kangdi 09-10-2023
Companies involved in heat patch production and sales must comply with relevant regulations including:
OTC drug manufacturing standards - Adhere to GMP requirements for safety, quality processes, testing and facilities.
Regional regulatory approvals - File and obtain OTC drug approvals in countries where the product will be marketed before sale.
Labeling laws - Include all required safety warnings, usage instructions, active ingredients, company info, expiration dates, etc. on packaging.
Biocompatibility testing - Assess potential skin irritation and sensitization through clinical evaluations according to ISO 10993.
Ingredient testing - Establish safety data and stability profiles over the expected shelf life aligned with pharmacopeia protocols.
Post-market surveillance - Monitor and report back any adverse effects observed in customers.
Staying current on applicable regulations and implementing necessary quality systems ensures heat patch products meet requirements prior to launch.