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CTFA Quality Assurance Guidelines

CTFA Technical Guidelines - Quality Assurance Guidelines

The publication of Technical Guidelines as a resource for manufacturers in the development of quality control programs has been an important association activity for more than 35 years. The assurance of product quality is essential in the continual efforts of the cosmetics industry to manufacture and market products in a global setting. Through the initiatives of the CTFA's Quality Assurance Committee, we bring you this updated volume of work which provides voluntary guidelines for the development of a Quality Assurance (QA) system based on Good Manufacturing Practices (GMPs).
These guidelines are intended to illustrate the different approaches that manufacturers of cosmetics and personal care products might follow to implement the principles of Good Manufacturing Practices as described in the ISO Technical Committee 217 International Standard 22716:2007 - Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing Practices. ISO Standard 22716 is included as a companion reference document with these guidelines. While these guidelines are intended to supplement ISO International Standard 22716, they are prepared from the perspective of product manufacturing and marketing in the United States and systems may be different in other jurisdictions.
These CTFA Quality Assurance Guidelines provide approaches that cosmetic manufacturers can use for establishing their good manufacturing practices and quality assurance programs. These Guidelines are not intended to be prescriptive in nature and are not intended to be implemented as standards. Individuals considering setting up QA and GMP systems must carefully assess their specifi c circumstances and adapt them as needed. Individuals using these Guidelines must also take into account any federal, state or local laws and regulations that may be applicable and ensure that they are complying with these requirements. Finally, these guidelines apply only to products that are defi ned as cosmetics according to applicable laws and regulations. In the United States, products that meet the legal defi nition for Over-The-Counter (OTC) drugs must follow the FDA GMP regulations that are described in 21 CFR Parts 210 and 211. The CTFA Quality Assurance Guidelines have been written for cosmetics, and therefore may not meet these regulatory requirements. Readers are referred to the applicable FDA regulations and guidance documents for these requirements.


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Personal Care Products Council [pcpc]


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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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