Good Manufacturing Practices (GMP)

Good Manufacturing Practices (GMP) are a set of principles and procedures designed to ensure that products are consistently manufactured, controlled, and documented according to quality standards appropriate for their intended use. In the cosmetics context, GMP covers all aspects of production from raw materials, premises, and equipment to training, personal hygiene, and quality control.

The EU Cosmetics Regulation (EC 1223/2009) requires that cosmetics be manufactured in accordance with GMP, and compliance with ISO 22716 (Cosmetics — Good Manufacturing Practices) creates a presumption of conformity. A statement of GMP compliance must be included in the Product Information File (PIF).

Under MoCRA, the FDA is required to establish GMP regulations for cosmetics. The agency has indicated these will likely be harmonized with ISO 22716. Until the final GMP rule is published, the FDA has encouraged manufacturers to implement ISO 22716 practices proactively.

Key GMP elements include documented procedures for all manufacturing operations, qualified and trained personnel, suitable premises and equipment, controlled raw material procurement and testing, in-process and finished product quality control, proper documentation and record keeping, complaint handling procedures, and self-inspection programs. Many contract manufacturers already hold ISO 22716 certification, but brands should verify this as part of their supplier qualification process.