Cosmetic Ingredients: Effci GMP Audit Checklist FOR
Cosmetic Ingredients: Effci GMP Audit Checklist FOR
Cosmetic Ingredients: Effci GMP Audit Checklist FOR
FOR
COSMETIC
INGREDIENTS
REVISION 2017
According to
EFfCI GMP GUIDE FOR COSMETIC INGREDIENTS 2017
Including the Certification Scheme for GMP for Cosmetic Ingredients
Revision 2017
In Collaboration with
EFfCI
EFfCI is a European trade association representing the chemical and natural ingredient
industries, the suppliers and service providers for the cosmetic industries. EFfCI was set up in
2000 to represent the collective interests of more than 100 cosmetic ingredient companies in
Europe.
PCPC
The Personal Care Products Council is the leading United States trade association representing
the global cosmetic and personal care products industry. Founded in 1894, the Council represents
more than 600 member companies who manufacture, distribute, and supply the vast majority of
finished personal care products marketed in the U.S. The Council’s core mission is to create a
productive business and regulatory environment to enable the industry to create safe, quality and
innovative consumer products. To carry out its mission, the Council maintains three primary
goals:
Sound Science: Support the safety of products and ingredients through strong, science-based
programs.
Modernized Legislation: Advocate legislative and regulatory policy positions to support
appropriate and coordinated regulation at the federal, state, and local levels
Global Access: Ensure global market access for member companies by working towards
Copyright © 2017 - The European Federation for Cosmetic Ingredients
Page i
harmonization of regulation, reducing trade barriers, and influencing the global regulatory and
trade environment.
ACKNOWLEDGEMENTS
This checklist was prepared by the EFfCI GMP Working group, who used with permission of IPEC
Europe the IPEC-PQG Good Manufacturing Practices Audit Guide for Pharmaceutical Excipients
2008 as a reference and a basis for further development of the Audit Checklist. The IPEC-PQG
Checklist has been adapted in such a way that it is better suited for use by cosmetic ingredient
manufacturers.
We would like to thank IPEC-PQG for allowing us to use their checklist in this way.
IPEC
The International Pharmaceutical Excipients Council (IPEC) is an international industry
association, formed in 1991 by manufacturers and end users of pharmaceutical excipients. It is an
umbrella organisation comprising three regional pharmaceutical excipient industry associations in
the United States, Europe, and Japan (which are known respectively as IPEC Americas, IPEC
Europe and JPEC). IPEC’s objective is to contribute to the development and harmonization of
international pharmaceutical excipient standards and the development of good manufacturing
practices for pharmaceutical excipients.
PQG
The Pharmaceutical Quality Group (PQG) was formed in 1977 to promote development of a
consistent approach to pharmaceutical quality and good manufacturing practices. The group has
expanded since that time and in 1990 the PQG produced three codes of practice to cover
pharmaceutical raw materials, and printed and contact packaging materials. In 1995 the codes
were revised and integrated with ISO 9002:1994. The code for raw materials was revised and
reissued as PS 9100:2002 Pharmaceutical excipients, an application standard and GMP checklist
for pharmaceutical excipients.
This Version of the EFfCI GMP Audit Checklist was prepared by:
EFfCI GMP Committee
David Melchior BASF Personal Care and Nutrition GmbH
Iain Moore Croda Europe Ltd
Peter Ungeheuer EFfCI
Marco Vassallo Complife Italia S.R.L.
Ulrike Schupmann BASF Personal Care and Nutrition GmbH
Andrea Gross DSM Nutritional Products Ltd.
Vincenzo Paolo Maria Rialdi Vevy Europe S.p.A
Karl Hensen Merck KGaA
Stephanie Bossy Intertek Certification France
Jean-Francois Cazaubon SEPPIC SA
Benoit Hun Stepan Europe S.A.S.
Fabien Luciani Ashland Specialities France sarl
Peter Radley Innospec Performance Chemicals
Stefan Knoop Symrise AG
Francois Jodogne SGS Belgium NV
FOR
COSMETIC INGREDIENTS
according to
EFfCI GMP FOR COSMETIC INGREDIENTS
Including the Certification Scheme for GMP for Cosmetic Ingredients
Revision 2017
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
Does the organisation only distribute CIs?, If yes then check
with Appendix F to ensure the exempted clauses are
correctly applied.
4.4.1k
Are any operations outsourced?
Are they included in the organisations QMS?
Is there evidence that GMP principles are followed in
outsourced operations?
See section 8.4
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
5 LEADERSHIP
5.1.1l
Are Quality Objectives set? Do these include GMP related
objectives and adherence to GMP as an objective?
Are the performance against objectives measured, reviewed
and objectives revised at an appropriate frequency?
5.1.1.m
Have resources been explicitly identified for GMP quality
system and for achievement of each quality objective? (see
5.1.2
How is meeting customer requirements and meeting GMP
requirements promoted and monitored by top management?
5.2 Policy
5.2.1e
see 5.1.1k above
5.2.1.f
Does the quality policy refer to Quality Objectives which
express the principles of GMP?
5.2.1g
Are the areas of the organisation where GMP is applied
clearly defined?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
5.2.2
Is the Quality Policy communicated in such a way that it is
available to all and familiar?
Is the requirement for GMP communicated in such a way
that is available to all?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
Are there identified job roles with responsibilities for the
following?
• Performing risk assessments required by GMP
for CI
• Approving suppliers of quality critical materials
and services
• Approving or rejecting raw materials, packaging
components, intermediates and finished CIs
• Reviewing records to ensure no critical errors
have occurred
• Investigating critical errors in records
• Participating in authorizing changes to
processes, specifications, procedures, test
methods
• Investigating failures and complaints
• Accepting or rejecting CI if it is made, processed,
packaged or held by another company
• Training personnel in GMPs
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
6 PLANNING
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
Are objectives periodically reviewed?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
7 SUPPORT
7.1 Resources
7.1.1 General
Are there sufficient resources (people, equipment, facilities,
buildings) to meet requirements of the GMPs?
7.1.3 Infrastructure
Is there a written risk assessment to evaluate the threats to
CI contamination that considers:
• location of the operations,
• state of repair,
• suitable size, construction and location of the
building and facility,
• ability to maintain a suitably clean building and
facility environment,
• operations that can affect the CI quality,
• presence of airborne contaminants, especially
highly sensitizing or toxic substances?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
7.1.3.1 Buildings and Facilities
Are buildings and facilities in a good state of repair?
Is their size, construction and location suitable for cleaning
and maintenance?
7.1.3.2 Equipment
Is equipment maintained in a good state of repair?
If processing occurs outdoors what controls are in place to
minimize risk to CI quality?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
How is the equipment designed? Has it been designed to
minimize the possibility of contamination from operator
contact in operations such as unloading of centrifuge bags,
use of transfer hoses, and operation of drying equipment and
pumps?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
7.1.3.3 Utilities
What utilities are used in the manufacture of CIs? How have
these utilities been assessed and appropriate action taken to
assure they do not contaminate the CIs?
7.1.3.4 Water
Is water used in the manufacture of the CIs? If so, is it
suitable for its intended use?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
The following questions in 7.1.4.1 to 7.1.4.6 should be
audited if the risk assessment has identified that controls
are needed for these aspects of work environment control.
7.1.4.1Cleaning
Are facilities maintained in an appropriately clean, sanitary
and orderly manner?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
7.1.4.3 Lighting
Is there adequate lighting?
7.1.4.4 Drainage
Where the CI is open to the environment, are drains of
adequate size? Are drains equipped with an air break or
other mechanism to prevent back flow?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
Are there adequate facilities for showering and/or changing
clothes?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
Are there records or logs maintained for calibration
operations?
7.2 Competence
Is there a procedure for identifying training needs and
providing the necessary training on a regular basis?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
What records are kept to demonstrate that GMP training is
conducted in a timely manner for new and temporary
employees / contractors?
7.3 Awareness
How is good awareness of GMP ensured through the
organization?
7.4 Communication
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
Is retention period defined for all documented information,
including external documents?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
Are batch records retained for at least one year past expiry
date of CI?
Are records clear, indelible and made directly after
performing the activity? Are they traceable to the time the
activity happened and the person making the record?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
8 OPERATION
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
Do the requirements include defined testing and other controls
on quality critical raw materials?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
8.2.2 Determination of the requirements for products and
services
Is there a procedure to determine customer requirements
related to the CI?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
8.4 Control of Externally provided processes, products and
services
8.4.1 General
What is the program to qualify or disqualify suppliers of raw
materials, packaging components and services that might
affect quality, and to verify that they have capability to
consistently meet agreed- upon requirements?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
Do bulk deliveries have additional controls to assure
material purity and freedom from contamination (e.g.
dedicated tankers, tamper-evident seals, certificate of
cleaning, testing, and/or audit of the supplier?
8.4.3 Information for external providers
Have the specifications for the raw material or packaging
components been provided to the supplier for their
acceptance? W hat system is in place to assure that
revisions to the specifications are provided on a timely basis
to the supplier?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
Are records available and readily retrievable for each batch
of CI produced? Do these records include complete
information relating to the production and control of each
batch? Such as:
• date/time each step was completed,
• identification of persons performing and checking
each significant operation,
• identification of major equipment and lines,
• material inputs to enable traceability,
• in-process and laboratory control results,
• statement of yield, unless not quantifiable
(e.g. as in some continuous processes),
• inspection of the packaging and labelling area
before and after use,
• labelling control records,
• description of sampling performed,
• failures, deviations, investigations and
• results of final CI inspection?
8.5.1.2 Equipment Cleaning
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
If equipment is not dedicated, what other types of materials
are manufactured in the same equipment? Is there a record
of the previous product manufactured using that
equipment? W hat controls are used to prevent cross-
contamination?
If CI is campaigned, is there an established interval between
complete cleaning of the equipment?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
Where finished CI is blended or mixed, to ensure batch
uniformity, how has the reproducibility of the blending or
mixing process been demonstrated?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
8.5.1.7 Records of Equipment Use
How is the sequence of activities for each piece of
equipment demonstrated i.e. production, maintenance and
cleaning?
Are batch / lot numbers assigned such that they are not
duplicated and enable tracing of all processes and batch
records for each batch?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
8.5.2.2 Inspection and Test Status
What system is used to identify the inspection status of
quality-critical items including raw materials, packaging,
intermediates and finished CIs?
8.5.2.3 Labelling
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
How are materials supplied by the customer handled?
8.5.4 Preservation
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
Are tamper evident seals used? If not, has a risk
assessment been completed to determine the non-
application of tamper evident seals?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
Is the Quality Unit involved in evaluation of changes that
may affect the quality of the CI?
8.6 Release of Products and Services
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
How are the results evaluated? Under what conditions may
a result be ignored?
8.6.6 Impurities
8.6.7 Stability
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
For CIs that have no stability data has a documented
testing or evaluation programme designed to evaluate the
stability characteristics of the CI been undertaken?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
Is there a procedure for handling returned CIs, including their
identification, and the requirement to evaluate their quality
before reuse or release?
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
9 PERFORMANCE EVALUATION
9.1.1 General
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
Who is responsible for implementing the corrective actions?
9.3.1 General
Does Management review include review of compliance to
GMP?
9.3.2 Management Review Input
Do inputs include conformance to requirements of GMP
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EFfCI GMP AUDIT CHECKLIST FOR COSMETIC INGREDIENTS
10 IMPROVEMENT
10.1 General
No additional requirements to ISO 9001:2015
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