INTERNATIONAL HEALTH AGENCIES BY ANUSHRI SRIVASTAV.pptx
Lợi ích của tiêu chuẩn EFfCI cho nguyên liệu mỹ phẩm
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EFfCI GMP
The benefits of the EFfCI GMP
Certification Scheme.
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EFfCI GMP Scheme – Benefits
The EFfCI GMP guide has been constantly developed and improved:
created in 2005 using the draft version of the IPEC-PQG Good Manufacturing
Practice Guide for Pharmaceutical Excipients as basis for a definition of Cosmetic
Ingredient GMP
updated in 2008 adding details of the certification scheme and the standard
aligned with ISO 9001:2008 in 2010
amended, collaborating with the cosmetic industry globally, for example in 2010 with
FEBEA (French cosmetic manufacturing association) and in 2017 with the Personal
Care Products Council (PCPC) USA.
The EFfCI GMP guide continues to be updated as market needs evolve and change.
The EFfCI GMP guide and standard is free to use and access. The EFfCI GMP certification
scheme is globally recognized and used.
For cosmetics manufacturers (customers), the benefits of choosing a supplier with EFfCI
GMP certification include;
the supplier meets an independently audited and world-wide, quality standard
a common standard of Quality Management Systems (QMS) and operations across
all suppliers with EFfCI GMP
knowing that end-user requirements and expectations are addressed
For cosmetics ingredients manufacturers (suppliers), the benefits of certification to EFfCI
GMP include;
operating to a standard that addresses risks and controls specific to cosmetics
ingredients and their markets with relevant requirements
operating to a common standard that adds onto ISO 9001:2015 and so requires little
change to the QMS
being scalable to suppliers of all sizes and types of manufacturing processes
operating to a standard that is widely accepted by cosmetics manufacturers
operating to a standard that ensures consistent auditor interpretations
For certifying bodies, the benefits of training and certifying to EFfCI GMP are;
the potential to audit in conjunction with ISO 9001
the ability to certify to a standard increasingly adopted globally
documented and approved auditor training
a register of qualified auditors
the ability, after training, to subsequently train others in the certifying bodies’
organization
providing a highly valued Certificate to their clients
To ensure the integrity of the Certification Scheme, EFfCI has established the Certification
Scheme Rules, which were developed further, especially in the 2017 version. These rules
and requirements are described in Appendix D “EFfCI GMP Certification Scheme Rules” and
in Appendix E “EFfCI GMP Certification Standard - Auditor Competency and Training
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Requirements” of the EFfCI GMP guide.
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It is the main purpose of the EFfCI GMP to have independent, fair, objective, and well-
experienced auditors for the certification process. Therefore, EFfCI established a
Registration Scheme for Auditors and Trainers. Only Auditors and Trainers approved by
EFfCI combined with recognized and approved Certifying Bodies are authorized to certify
organizations as EFfCI GMP compliant.
If an EFfCI approved and registered auditor/Certifying Body certifies an organization, it is
mutually recognized by the other Certifying Bodies. Hence, there is no need to use different
Certifying Bodies, even if some interested parties would prefer it.
All recognized Certifying Bodies and registered auditors are available on www.effci.com. This
allows interested parties to validate the Certificate and or audit report as being compliant to
the EFfCI GMP Scheme rules.
An organization desiring to be certified should directly contact an EFfCI registered Certifying
Body which is listed on the EFfCI website.
The Scheme ensures that suppliers holding EFfCI GMP Certificates in accordance with these
rules will have been assessed and certified so as to provide maximum assurance of the
quality of their ingredients.
EFfCI is happy to support in case of questions. Please contact us www.effci.com.