EFfCI GMP FOR COSMETIC INGREDIENTS. Revision 2017

Transcription

1 EFfCI GMP FOR COSMETIC INGREDIENTS Including the Certification Scheme for GMP for Cosmetic Ingredients Revision 2017 Prepared by the European Federation for Cosmetic Ingredients In Collaboration with Copyright EFfCI 2005, 2008, 2012, 2017

2 FOREWORD The quality of cosmetic ingredients is critical to assure the safety, quality and efficacy of cosmetic products and related personal care products. Cosmetic ingredients have a wide range of applications and are essential components of the cosmetic product formulation. Therefore, applying appropriate good manufacturing practice (GMP) principles to cosmetic ingredients is essential. 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. The idea underlying this definition of GMP for Cosmetic Ingredients is to provide manufacturers with a tool for implementing an appropriate and workable GMP system. The authors would very much appreciate comments as input in the further development of this document. This is the fifth edition of this document. The original document was issued in 2005 and updated in 2008 (when details of the certification scheme and standard were added), aligned with ISO 9001:2008 in 2010 and comprehensively amended following collaboration with the French cosmetic manufacturing association, FEBEA when the opportunity was taken to introduce quality risk management approaches to aid the implementation of suitable GMP principles to chemical synthesis and related manufacturing processes. The inclusion of the Certification Scheme in 2008 allowed cosmetic ingredient suppliers to provide independent certification in order to show that their products have been prepared in accordance with the. Certification requires the supplier to hold a valid ISO 9001 Certificate which covers at least all of the activities in the manufacture and supply of cosmetic ingredients. In this version, there has been a comprehensive and complete review and revision of the Guide and Standard, including the alignment to ISO 9001:2015, a new side-by-side presentation of the GMP Guide and Standard ( CI-GMP ) and a revision of all the Appendices. The previous Appendix D has been incorporated into the main text. In addition, this document has been revised in collaboration with a team of experts from the Personal Care Products Council (PCPC) in order to ensure the GMP criteria are relevant globally. This ensures that this edition of the GMP for cosmetic ingredients reflects the most recent version of the standard ISO 9001 and provides the best basis for Certification to the GMP for Cosmetic Ingredients worldwide. Copyright 2005, 2008, The European Federation for Cosmetic Ingredients ii

3 Layout of the Document The document incorporates existing GMP principles, WHO (World Health Organization) GMP Guidelines for Excipients, IPEC Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients 2006, and international quality management system requirements as developed by The International Organization for Standardization (ISO). Section 0 provides a general introduction to the document. Sections 1-10, provide guidance and standards for compliance with relevant GMP principles and implementation of a quality management system. These sections also recommend measures to limit cosmetic ingredient contamination. Individual manufacturers should assess the GMP principles for suitability for application to their ingredients and, where justified, take additional measures on a risk based approach. The Appendices cover supporting guidance for the Auditor requirements, a glossary, references, requirements for distributors of cosmetic ingredients and a list of contributing authors. Recertification to the 2017 Version Organizations holding certification to the 2012 edition of EFfCI GMP will need to align their quality management system to the 2017 edition of the EFfCI GMP standard and seek certification to it. Organizations shall have until the end of 2018 to transition to this version of the GMP Guide and standard. From the 1 st January 2019 only a certificate to EFfCI GMP: 2017 will be valid. This version of the and Standard does not include any major changes to the requirements from the 2012 version. It is expected that a transition to the 2017 edition could be achieved in a surveillance or a recertification audit. EFfCI The European Federation for Cosmetic Ingredients aisbl Head Office: Avenue Louise Brussels Belgium Ent. No For further information see or contact EFfCI at contact@effci.com All rights reserved. The and Standard (this book) and its contents are proprietary to EFfCI. This book may not be copied, reproduced or distributed in any form, or used, referred to or modified, in part or in full, for any uses, including non-commercial uses, without prior express permission from the publishers. Copyright 2005, 2008, The European Federation for Cosmetic Ingredients iii

4 TABLE OF CONTENTS FOREWORD ACKNOWLEDGEMENTS ii vi 0 INTRODUCTION General Quality management principles Process approach Relationship with other management system standards 3 1 SCOPE 3 2 NORMATIVE REFERENCES 3 3 TERMS AND DEFINITIONS Cosmetic ingredients (CI) 3 4 CONTEXT OF THE ORGANIZATION Understanding the organization and its context Understanding the needs and expectations of interested parties Determining the scope of the quality management system Quality management system and its processes 5 5 LEADERSHIP Leadership and commitment Policy Organizational roles, responsibilities and authorities 7 6 PLANNING Actions to address risks and opportunities Quality objectives and planning to achieve them Planning of changes 9 7 SUPPORT Resources Competence Awareness Communication Documented information 16 8 OPERATION Operational planning and control Requirements for products and services Design and development of products and services Control of externally provided processes, products and services Production and service provision Release of products and services Control of non-conforming outputs 29 Copyright 2005, 2008, The European Federation for Cosmetic Ingredients iv

5 9 PERFORMANCE EVALUATION Monitoring, measurement, analysis and evaluation Internal audit Management review IMPROVEMENT General Nonconformity and corrective action Continual improvement 33 APPENDIX A DEFINITIONS AND GLOSSARY 34 APPENDIX B REFERENCES 38 APPENDIX C ADDITIONAL SOURCES OF INFORMATION 39 APPENDIX D EFfCI GMP CERTIFICATION SCHEME RULES 40 APPENDIX E EFfCI GMP CERTIFICATION STANDARD AUDITOR COMPETENCY AND TRAINING REQUIREMENTS 44 APPENDIX F: CLAUSES IN SECTION 8 WHICH ARE NOT APPLICABLE TO DISTRIBUTORS 48 APPENDIX G: CONTRIBUTORS TO THE EFfCI GMP GUIDE AND STANDARD 49 Copyright 2005, 2008, The European Federation for Cosmetic Ingredients v

6 ACKNOWLEDGEMENTS This guide was originally prepared by the EFfCI GMP Working group, who used, with permission, the draft version of the IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients 2006 as the basis for a definition of Cosmetic Ingredient GMP. We would like to thank IPEC-PQG for allowing us to use their guide 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 organization comprising three regional pharmaceutical excipient industry associations in the United States, Europe, Japan, China and India (which are known collectively as the IPEC Federation). 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. For further information, see PQG The PQG was formed in 1977 to promote development of a consistent approach to pharmaceutical quality and good manufacturing practice. PQG provides support to the pharmaceutical industry and its suppliers with training, discussion meetings and certification standards and guidance. In 1990 the PQG published three codes of practice to cover pharmaceutical raw materials, printed and contact packaging materials. In 1995 the codes were revised and were 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 guide for pharmaceutical excipients. Collaboration with IPEC led to the established and widely accepted IPEC/PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients, For further information, visit FEBEA The Fédération des Entreprises de la Beauté - French Federation of Fragrance, Cosmetics and Toiletries (FEBEA) is a trade association for beauty and wellness companies (perfume, cosmetics, hygiene and personal care products, hair care), is made up of more than 300 companies. FEBEA has two central missions. convince public authorities to implement the most favorable framework for the cosmetics industry (lobbying), assist (on a national and international scale) its members in developing their business to its full potential (consulting). 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 harmonization of regulation, reducing trade barriers, and influencing the global regulatory and trade environment. Copyright 2005, 2008, The European Federation for Cosmetic Ingredients vi

7 0 INTRODUCTION 0.1 General This document is intended to be a baseline guide that defines the extent and point of application of fundamental good manufacturing practice (GMP) principles for cosmetic ingredient manufacture. It covers the quality management systems and the extent of GMP necessary throughout the manufacturing process. It is intended to be used internationally to assist in determining whether the facilities and manufacturing controls used for the production of cosmetic ingredients adequately ensure that they possess the quality, and purity which they purport to possess, and that they are suitable for their intended use. The text provides the guidance and standards necessary for manufacturing cosmetic ingredients but not all of the details. As an international document for a wide range of personal care ingredients, it cannot specify all national legal requirements or cover all particular characteristics of every cosmetic ingredient. The quality management system standard chosen as a framework for this guide is ISO 9001:2015, which is appropriate for manufacturing facilities. The headings in this document have been aligned with the ISO 9001:2015 numbering because many cosmetic ingredient manufacturers already use that standard as a basis for their quality management system, including those companies that already have third party certification. Additional headings or numbering lists are included as required to introduce the additional guidance on GMP, where not covered by existing ISO 9001:2015 clauses. Text in italics is ISO 9001:2015 text. This version of : has highlighted the importance of risk assessments and has made ISO 9001:2015 requirements more specific for cosmetic ingredient manufacturing sector; is more detailed with reference to the 'Control of Changes'; has defined the obligation to establish an independent quality unit and its activities. Each clause in this document contains two sections. One, in black text (), is guidance on the GMPs, why they are needed and aids implementation of these GMPs for cosmetic ingredients. The second, in red text (), is a standard and is the annex to ISO 9001 detailing what to do which allows for objective auditing of the GMP and quality management systems. The EFfCI GMP Standard includes additional requirements that support the application of GMP to the manufacture and distribution of Cosmetic Ingredients over and above those defined for a quality management system in ISO 9001:2015. Where the document indicates no additional comments/requirements then there are no further aspects of the quality management system that have to be implemented for GMP over those required by ISO A manufacturer may apply the GMP standard with or without certification. However, GMP certification has the benefit of providing assurance to customers that a manufacturer conforms to this quality management system through independent verification. EFfCI believes that merging GMP principles for cosmetic ingredient manufacturing into the ISO 9001:2015 quality management system enhances not only the quality management, but an organization s operational procedures as well. Cosmetic product formulators worldwide have shown increasing regard for compliance with ISO 9001:2015 as almost a necessary Copyright 2005, 2008, The European Federation for Cosmetic Ingredients Page 1

8 qualification for their suppliers. Obtaining certification is however, a business decision and not a recommendation of this guide. Organizations not choosing certification should perform a gap analysis on the standard and address any gaps. If an organization desires to be certified, only those approved EFfCI Certifying Bodies which are listed on the EFfCI website using auditors which have been trained in the EFfCI GMPs should be used Applying cosmetic ingredient GMP Cosmetic ingredient manufacture shall be carried out in accordance with GMP concepts consistent with this document. When considering how to use this document, each manufacturer should consider how it might apply to their products and processes. Since cosmetic ingredients are diverse, some principles of the document may not be applicable to certain products and processes. Use of risk assessments can help determine applicabilities as indicated in the text. 0.2 Quality management principles The objective of cosmetic ingredient GMP is to ensure that the manufacture of cosmetic ingredients results in a consistent material with the desired appropriate quality characteristics. The emphasis of the GMP for cosmetic ingredients is to assure product integrity, consistency, avoid product contamination, ensure that appropriate records are maintained, and confer traceability. Judgement based on a thorough knowledge of the process and an understanding as to the intended use of the product is required to determine at which processing step GMP should be implemented. A risk based approach should be used to apply the GMP concepts in this document. EFfCI GMP is based on and aligned with ISO 9001, and it must be remembered that when ISO 9001 discusses validation this does not mean the same requirements as seen in pharmaceutical validation activities and programmes. This aligns EFfCI GMPs with the international standards and regulations for cosmetics which do not require validation. 0.3 Process approach General EFfCI GMP builds on all the key quality management principles in ISO 9001:2015. Those organizations who are compliant with ISO 9001:2015 will find that it is simple to build in the additional requirements for the EFfCI GMPs. No further comments Plan Do Check Act Cycle No further comments Copyright 2005, 2008, The European Federation for Cosmetic Ingredients Page 2

9 0.3.3 Risk based thinking The manufacture and distribution of cosmetic ingredients is a diverse activity. As a result it is not possible to define a single set of rules which are applicable to all cosmetic ingredients. In such circumstances a risk based approach is required in which the organization identifies the potential risks to cosmetic ingredient quality and consumer safety and then takes measures to mitigate those risks. EFfCI GMP has several clauses which outline a risk based approach is required. A suitable risk assessment could be in the form of a listing of identified threats with an assessment of the probability of realising those threats and the consequences those threats may have on cosmetic ingredient quality and consumer safety. In determining the risks consideration should be given to existing mitigation measures as well as any new ones identified by the risk analysis. Acceptance criteria for residual risks remaining after the implementation of mitigation measures should be defined. Risk based methods such as HACCP (Hazard Analysis and Critical Control Point), FMEA (Failure Modes and Effect Analysis) etc. or a detailed process flow diagram may be used to identify the unit operations, required equipment, stages at which various substances are added, key steps in the process, critical parameters (time, temperature, pressure, etc.), and necessary monitoring points. 0.4 Relationship with other management system standards The and Standard is intended to be fully compatible with ISO 9001:2015and the ISO high level structure for management system standards (Annex SL). 1 SCOPE This and Standard is intended to be applicable to all cosmetic ingredient manufacturers and distributors. Certification to the standard is recommended when an organization needs to demonstrate it has implemented a suitable level of GMP for the manufacture and/or distribution of cosmetic ingredients. Throughout this annex, references to GMP for Cosmetic Ingredients will be referred to as GMP. 2 NORMATIVE REFERENCES ISO 9001:2015 Quality Management Systems Requirements. 3 TERMS AND DEFINITIONS See Appendix A for specific terms used in this document. 3.1 Cosmetic ingredients (CI) Cosmetic ingredients are substances or preparations that are intentionally included in a cosmetic product. Copyright 2005, 2008, The European Federation for Cosmetic Ingredients Page 3

10 4 CONTEXT OF THE ORGANIZATION 4.1 Understanding the organization and its context No additional requirements to ISO The organization should understand and identify the internal and external issues concerning cosmetics and cosmetic ingredients and include these in the design of its quality management and GMP systems. It should review these issues as they change and make suitable amendments to incorporate any changes (see Section 6.3, and 9.3). In particular, organizations should monitor relevant legislation for potential changes governing the manufacture and use of cosmetic ingredients. 4.2 Understanding the needs and expectations of interested parties Customers and the regulatory authorities who oversee cosmetics as well as consumers of cosmetics shall be evaluated as interested parties. Changes to the interested parties and or their requirements shall be monitored and reviewed (see Section 6.3, and 9.3). The organization should identify, monitor and review the interested parties and their relevant requirements because these will aid in defining the scope of the quality management and GMP systems, as well as identifying risks and opportunities for the organization. Interested parties will include customers and the regulatory authorities who oversee cosmetics as well as the consumers who will use the cosmetics. 4.3 Determining the scope of the quality management system This Standard includes additional requirements to ISO 9001:2015 for certification purposes which allows organizations to demonstrate compliance with GMP for Cosmetic Ingredients. The organization shall apply all the requirements of the GMP Standard if they are applicable within the determined scope of its GMP and quality management system. If any requirements are determined as not applicable then they may only be omitted if this does not adversely affect the quality of the cosmetic ingredients. The scope of the organization s GMP and quality management system shall: be completely covered by the scope of the certified ISO 9001 quality management system, include a list of activities, facilities, product groups or products, be defined and controlled as documented information. When considering how to use this document, each manufacturer should consider how it might apply to their products and processes. The manufacturing and other operations performed on cosmetic ingredients are diverse; therefore, there is significant diversity in the threats to the assurance of cosmetic ingredient quality. Therefore, some principles in this document may not be applicable in all circumstances. However their applicability should be evaluated before any decision is made not to implement them. Copyright 2005, 2008, The European Federation for Cosmetic Ingredients Page 4

11 The scope of the cosmetic ingredient GMPs should: be completely covered by the scope of the ISO 9001 certification, include a list of facilities, services, product groups or products, be defined and controlled as documented information. For organisations which only distribute cosmetic ingredients Appendix F provides a list of sections of chapter 8, which are not applicable to their operations. 4.4 Quality management system and its processes The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall: i) determine and apply the criteria and methods needed for the fulfilment of the cosmetic ingredient GMP requirements and their effective implementation, j) include all manufacturing, testing or other operations that are required to control and affect cosmetic ingredient quality k) for outsourced operations, ensure the relevant cosmetic ingredient GMP requirements are applied (See Section 8.4) No additional requirements Cosmetic ingredient manufacturers should establish, implement, maintain and continually improve the GMP and quality management processes required to assure cosmetic ingredient quality. The GMP principles outlined in this document provide a reasonable basis for the quality management system used in the manufacture of cosmetic ingredients. Where manufacturing, testing or other operations that could affect cosmetic ingredient quality are outsourced, these activities should be identified in the cosmetic ingredient manufacturer's quality management system (See Section 8.4), and the cosmetic ingredient manufacturer should ensure that the applicable GMP principles in accordance with this Annex are applied to those operations. 5 LEADERSHIP 5.1 Leadership and commitment General Top management shall demonstrate leadership and commitment with respect to the quality management system by: k) communicating the importance of GMP to the organization and its inclusion in the quality management system; l) ensuring that GMP objectives are defined, established and implemented, and m) providing the resources needed to maintain the GMP quality management system and implement GMP objectives Copyright 2005, 2008, The European Federation for Cosmetic Ingredients Page 5

12 Top management should demonstrate the importance they place on meeting the needs of the interested parties, including complying with appropriate regulations and these GMP principles defined herein. This should be accomplished through the development of a quality policy and establishment of quality objectives. Where quality objectives are set, adequate resources should be provided by top management and the progress towards these should be reviewed at planned intervals Customer focus Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that: d) there is a corporate emphasis on meeting the requirements of GMP for cosmetic ingredients. It is the responsibility of top management to demonstrate leadership and commitment to ensure there is a corporate emphasis on satisfying customer requirements and meeting the requirements of GMP. 5.2 Policy Establishing the quality policy Top management shall establish, implement and maintain a quality policy that: e) includes a commitment to the implementation of GMP for cosmetic ingredients, f) provides a framework for setting quality objectives, including objectives for adherence to GMP. g) defines where the GMP as defined in this Standard will be used in the organization. Note: the applicable requirements in ISO 9001:2015 bullet c) includes GMP for cosmetic ingredients Top management should demonstrate its commitment to the corporate GMP and quality policy and ensure that it is implemented within the operational unit. The GMP and quality policy should support continual improvement of the quality management system with regular review. Management should participate in the development of the company's GMP and quality policy and provide the resources necessary for its development, maintenance, and deployment Communicating the quality policy No additional requirements to ISO 9001:2015. The requirements for GMP should be communicated throughout the organization along with the quality policy. Copyright 2005, 2008, The European Federation for Cosmetic Ingredients Page 6

13 5.3 Organizational roles, responsibilities and authorities Responsibility and authority shall be defined by top management and communicated within the organization; in particular the responsibility shall be defined for ensuring that the GMP for cosmetic ingredients are communicated, understood, reported and integrated into the quality management system. Top management shall establish an independent Quality Unit. The independence of the Quality Unit shall be documented and demonstrated by showing the inter-departmental relationships as well as the relationship to top management. The Quality Unit shall ensure that activities are conducted in accordance with the GMPs in this document and the associated risk assessments. The Quality unit shall participate in the investigation of critical deficiencies. Top management shall ensure the following responsibilities are assigned and defined: performing the risk assessments required by these GMPs approving suppliers of quality critical materials and services, approving or rejecting raw materials, packaging components, intermediates and finished cosmetic ingredients, reviewing records to ensure that no critical errors have occurred or, if these occur, that they are fully investigated, participating in authorizing changes to processes, specifications, procedures, test methods and investigating failures and complaints, approving or rejecting of the cosmetic ingredient if it is manufactured, processed, packaged, or held under contract by another company, and training personnel in GMPs. Other tasks that may be critical to the manufacture of the cosmetic ingredient. Internal audits shall verify that these responsibilities have been undertaken as defined (see section 9.2). Personnel whose role is critical to ensuring cosmetic ingredient quality shall have written job descriptions. Roles, responsibilities and authorities should be clearly defined by top management and communicated within the organization. In particular, the responsibility should be defined for ensuring that the GMPs for cosmetic ingredients are communicated, understood, reported and integrated into the quality management system. An independent Quality Unit should be established to ensure freedom from conflicts of interest. The Quality Unit should ensure activities are identified and undertaken as defined and in accordance with the GMPs in this document and the associated risk assessments. The Quality Unit should participate in the investigation of critical deficiencies. The independence of the Quality Unit should be documented and demonstrated by showing the inter-departmental relationships as well as the relationship to top management. It is the Quality Unit s responsibility to maintain the quality management system. Note: The Quality Unit may comprise Quality Assurance and / or Quality Control functions. Copyright 2005, 2008, The European Federation for Cosmetic Ingredients Page 7

14 Top management should assign an individual (or individuals) with the following defined responsibilities that are critical to cosmetic ingredient quality and the assurance of consumer safety: performing the risk assessments required by these GMPs approving suppliers of quality critical materials and services, approving or rejecting raw materials, packaging components, intermediates and finished cosmetic ingredients, reviewing records to ensure that no critical errors have occurred or, if these occur, that they are fully investigated, participating in authorizing changes to processes, specifications, procedures, test methods and investigating failures and complaints, approving or rejecting of the cosmetic ingredient if it is manufactured, processed, packaged, or held under contract by another company, and training personnel in the GMPs preparation of Certificates of Analysis (see Section 8.6.5) Other tasks that may be critical to the manufacture of the cosmetic ingredient Internal audits should verify that these responsibilities have been undertaken as defined (see Section 9.2). Personnel whose role has an impact on cosmetic ingredient quality should have written job descriptions. 6 PLANNING 6.1 Actions to address risks and opportunities The organization shall conduct and record risk assessments as required in the other sections of this standard. Where existing controls to minimize the risks to cosmetic ingredient quality are not considered effective then additional measures shall be implemented and these measures documented in the quality management system. Risk assessments shall be reviewed and revised in the event of non-conformity of the product or relevant aspect of the quality management system. Additional measures shall be implemented as identified. The organization should conduct and record risk assessments (see Section ) related to cosmetic ingredient quality and consumer safety based on the context of the organization (see Section 4.1 and 4.2). The use of risk assessments is indicated in the remaining sections of this Guide and includes: 6.3 Planning of Changes Infrastructure Environment for the operating of processes Equipment Cleaning Control of externally provided processes, products and services - general Packaging Systems Reprocessing/Reworking Copyright 2005, 2008, The European Federation for Cosmetic Ingredients Page 8

15 Where existing controls to minimize the risks to cosmetic ingredient quality are not considered effective then additional measures should be implemented and documented in the quality management system. The effectiveness of these actions should be evaluated. A suitable risk assessment could be in the form of a listing of identified threats with an assessment of the probability of realising those threats and the consequences those threats may have on cosmetic ingredient quality and consumer safety. In determining the residual risks consideration should be given to existing mitigation measures as well as any new ones identified by the risk analysis. Acceptance criteria for residual risks should be defined. Risk assessments should be reviewed and revised in the event of non-conformity of the product or relevant aspect of the quality management system. Additional measures should be implemented as identified. 6.2 Quality objectives and planning to achieve them Top management shall set objectives to maintain and improve compliance to GMP. Top management should set objectives for adherence to GMP to ensure that the cosmetic ingredient manufacturer maintains and improves its performance. Objectives should be deployed throughout the organization, be measurable and consistent with the quality policy, and have a periodic review. 6.3 Planning of changes There shall be a documented procedure defining the responsibilities and requirements for the evaluation and approval of changes that may impact the quality management system. Evaluation and approval of changes shall occur prior to the implementation. Records of the change control process shall be retained. There should be a documented procedure defining the responsibilities and requirements for the evaluation and approval of changes that may impact the quality management system. There should be consideration given to the impact any changes made have on related activities and procedures. A defined plan of actions commensurate with the risks should be developed for the change. Evaluation and approval of changes should occur prior to their implementation. Records of the change control process, action plans and their implementation should be retained. Note: See also Section Copyright 2005, 2008, The European Federation for Cosmetic Ingredients Page 9

16 7 SUPPORT 7.1 Resources General People Resource requirements to meet the requirements of this Guide should be identified. A gap analysis based on this guide as well as internal audits can be used for this purpose. The organization shall consider the c) GMP requirements of this standard. Top management should provide sufficient resources (e.g., people, equipment, materials, buildings and facilities) to implement, maintain and improve the quality management system and to manufacture, package, test, store and release each cosmetic ingredient in a manner consistent with this guide. The organization shall determine and provide the persons necessary for the effective implementation of GMP. Top management should determine and provide sufficient people to implement, maintain and improve the quality management system and to manufacture, package, test, store and release each cosmetic ingredient in a manner consistent with this guide (see also Section 7.2) Infrastructure The infrastructure shall be managed, operated, cleaned and maintained to avoid raw material, intermediate and cosmetic ingredient contamination (including control of particulate matter, microbiological control and control of water quality where applicable). The organization shall conduct and record a risk assessment based on the organization s intended use of the infrastructure to identify areas in which the cosmetic ingredient is at risk for contamination from deficiencies in buildings and/or facilities. The risk assessment shall consider the following at a minimum to identify where the cosmetic ingredient is at risk from contamination: a) location of the operations (e.g. internal, external), b) state of repair of the building and facility, c) suitable size, construction and location, d) ability to maintain a suitably clean building and facility environment, e) operations that can affect the cosmetic ingredient quality, f) presence of airborne contaminants, especially highly sensitizing or toxic substances. Where existing controls to minimize the risks of cosmetic ingredient contamination are not considered effective then additional measures shall be documented and implemented. Only authorised users shall have access to computer systems which are critical to the assurance of cosmetic ingredient quality. Copyright 2005, 2008, The European Federation for Cosmetic Ingredients Page 10

17 The organization should provide and maintain the infrastructure required to avoid raw material, intermediate and cosmetic ingredient contamination (including control of particulate matter, processing materials and aids, microbiological control and control of water quality where applicable). The organization should conduct and record a risk assessment based on the organization s intended use of the infrastructure to identify areas in which the cosmetic ingredient is at risk for contamination from deficiencies in buildings and/or facilities. The risk assessment should consider the following at a minimum: a) location of the operations (e.g. internal, external), b) state of repair of the building and facility, c) equipment construction and location, d) ability to maintain a suitably clean building and facility environment, e) operations that can affect the cosmetic ingredient quality, f) presence of airborne contaminants, especially highly sensitizing or toxic substances. Where existing controls to minimize the risks of cosmetic ingredient contamination are not considered effective then additional measures should implemented and these measures documented in the quality management system. The following subsections provide more detailed guidance on the specific aspects related to infrastructure Buildings and facilities Buildings and facilities used in the manufacture, processing, packaging, testing, or storage of a cosmetic ingredient should be maintained in a good state of repair and should be of suitable size, construction, and location to facilitate cleaning, maintenance, and correct operation. The prevention of cross contamination should be considered in the design and operation of the manufacturing processes and facilities. There should be adequate facilities for the testing of raw materials, packaging components, intermediates, and finished cosmetic ingredients Equipment Equipment used in the manufacture, processing, packaging, testing, or storage of a cosmetic ingredient should be maintained in a good state of repair and should be of suitable size, construction, and location to facilitate cleaning, maintenance, and correct operation. Where equipment is located outdoors there should be suitable controls to minimise the risk to the cosmetic ingredient from the environment (e.g. processing within a closed system) Equipment construction Process equipment should be constructed so that contact surfaces will not be reactive, additive, or absorptive and thus not alter the quality of the cosmetic ingredient. Substances required for operation, such as lubricants or coolants, should not come into contact with raw materials, packaging materials, intermediates, or finished cosmetic ingredients unless technically unavoidable. Exposure of the cosmetic ingredient to extraneous materials (such as additives, lubricants, etc.) that are not part of the formulation should be avoided. Where exposure is not technically avoidable, the substances should be compatible with use in cosmetic ingredients. Equipment should be designed to minimize the possibility of contamination caused by direct operator contact. Copyright 2005, 2008, The European Federation for Cosmetic Ingredients Page 11

18 Equipment maintenance Written procedures should be established and followed for maintenance of critical equipment used in the manufacture, processing, packaging, testing or, holding of the cosmetic ingredient. There should be records of the use and maintenance of quality critical equipment. These records can be in the form of a log, computer database, or other appropriate documentation Computer systems Computer systems used in the manufacturing and/or testing of cosmetic ingredients should have sufficient controls for operation, maintenance and prevention of unauthorized access or changes to data software and computer hardware. The following controls should be established: only authorised users should have access to the computer systems retention of suitable back-up systems such as copies of the programs and files, assurance that changes are verified and documented, and only made by designated personnel. Electronic data used as a record should meet the requirements for the control of records (see Section ) Utilities used in manufacture of cosmetic ingredients Utilities (e.g. nitrogen, compressed air, steam etc.) used in the manufacture of cosmetic ingredients that could impact upon product quality should be assessed and appropriate action taken to control the risk Water used in manufacture of cosmetic ingredients Water that comes into direct contact with the cosmetic ingredient during manufacture or remains in the final product should be suitable for its intended use. Unless otherwise justified, water that comes into direct contact with the cosmetic ingredient should, at a minimum, meet World Health Organization (WHO) guidelines for drinking (potable) water quality. If drinking (potable) water is insufficient to assure quality, and tighter chemical and/or microbiological water quality specifications are required, appropriate specifications should be set, e.g. physical and chemical attributes, total microbial counts and objectionable organisms. Where water used in the process is treated by the manufacturer to achieve a defined quality, the treatment process should be specified and monitored with appropriate action limits Environment for the operating of processes The work environment shall be managed to minimize risks of cosmetic ingredient contamination. A documented risk assessment shall be carried out to determine the necessary controls. The documented risk assessment shall cover the following controls, as applicable: a) air handling systems, b) special environments, c) cleanliness and sanitary conditions, d) waste segregation and disposal, e) pest control, f) other risk assessments required by this Standard. Copyright 2005, 2008, The European Federation for Cosmetic Ingredients Page 12

19 Where maintenance of the work environment is critical to cosmetic ingredient quality, the controls shall be documented. The work environment should be managed and controlled to minimize risks of cosmetic ingredient contamination. A documented risk assessment should be carried out and recorded to determine the necessary controls. The documented risk assessment should cover the following controls, as applicable: a) air handling systems (e.g. Heating, Ventilation and air conditioning (HVAC) systems), b) special environments, c) cleanliness and sanitary conditions, d) waste segregation and disposal, e) pest control, f) other environmental factors that could impact cosmetic ingredient quality (e.g. Building Management Systems), g) other risk assessments required by this document. Where maintenance of the work environment is critical to ensure cosmetic ingredient quality, the controls should be documented in the quality management system and suitable records retained. The following subsections provide more detailed guidance on the specific areas evaluated in the risk assessment and should be adopted where the risk assessment has identified these controls are necessary Cleaning Adequate cleanliness is an important consideration in the design and operation of cosmetic ingredient manufacturing facilities. Buildings used in the manufacture, processing, packaging, or holding of a cosmetic ingredient should be maintained in an appropriately clean condition. Where maintenance of clean and sanitary conditions is critical to cosmetic ingredient quality, written procedures should assign responsibility for cleaning and describe in sufficient detail the schedules, methods, equipment, and materials to be used in cleaning the buildings and facilities. These procedures should be followed and cleaning should be documented. Cleaning procedures should be verified to be appropriate for the surface being cleaned. Waste should be segregated, held and disposed of in a timely and appropriate manner Pest Control A risk assessment should be completed to determine the need for pest control and the extent of any implemented programme. It should also include an assessment of the chemicals used in the programme and the threats these may pose to cosmetic ingredient quality. Where the cosmetic ingredient is at risk of contamination from pests then buildings should be free of infestation by rodents, birds, insects, and other vermin. Some starting materials, particularly botanicals, may contain some unavoidable contamination, such as rodent or other animal filth or infestation. Control methods should be identified to prevent the increase of contamination or infestation in holding areas, or its spread to other areas of the plant. Copyright 2005, 2008, The European Federation for Cosmetic Ingredients Page 13

20 Lighting Adequate light should be provided in all areas to facilitate cleaning, maintenance, operations and testing. The hazards posed from glass lighting components should be included in the work environment risk assessment Drainage In areas where the cosmetic ingredient is open to the environment, drains should be of adequate size and, where connected directly to a sewer, should be provided with an air break or other mechanical device to prevent back siphoning Personnel hygiene Where cosmetic ingredients are exposed to the environment, personnel should wear protective apparel such as head, face, hand, arm coverings as necessary. Jewellery and other loose items should be removed or covered to protect the cosmetic ingredient. Personnel should practice good sanitation and health habits. The storage and use of food, drink, tobacco products or similar items should be restricted to certain designated locations separate from manufacturing areas Washing and toilet facilities Adequate washing facilities, including hot and cold water, soap or detergent, air dryers or single service towels, and clean toilet facilities should be provided. These should be easily accessible from working areas. Washing facilities should not pose a threat to cosmetic ingredient quality. Adequate facilities for showering and/or changing clothes should be provided, where appropriate Monitoring and measuring resources General No additional requirements to ISO 9001:2015. Monitoring and measurement resources should be suitable for the evaluation of cosmetic ingredients Measurement traceability No additional requirements to ISO 9001:2015. Measuring and test equipment, including computer software, identified as being critical parts of the quality management system, should be properly calibrated and maintained. This includes all in-process instruments identified as quality management system instruments, as well as test equipment used in the laboratory. The control program should include the standardization or calibration of quality critical instruments and equipment at suitable intervals in accordance with an established written program. This program should contain specific directions, schedules, limits for accuracy and precision as appropriate, and provisions for remedial action in the event that accuracy and/or precision limits are not met. Calibration standards should be traceable to recognised national or compendial standards as appropriate. Copyright 2005, 2008, The European Federation for Cosmetic Ingredients Page 14

21 Instruments and equipment not meeting established specifications should not be used and an investigation should be conducted to determine the validity of the previous results since the last successful calibration. The current calibration status of quality critical instruments and equipment should be known and verifiable to users Organizational knowledge No additional requirements to ISO 9001:2015. The organization should have current knowledge of the cosmetic industry, its regulatory requirements, customer and consumer expectations and GMP for cosmetic ingredients. This knowledge should be made available to the extent necessary for personnel to perform their duties and ensure the quality and safety or integrity of the cosmetic ingredient. Note: Participation in EFfCI activities provides an excellent means of gaining this knowledge. 7.2 Competence The organization shall: e) perform refresher training on GMP and personal hygiene at defined intervals to ensure that employees remain familiar with applicable GMP principles. Personnel performing work affecting the quality of cosmetic ingredients should have the appropriate education, training and/or experience for their assigned tasks. Job descriptions should include the competencies required for the duties performed. The cosmetic ingredient manufacturer should establish and maintain procedures for identifying training needs and providing the necessary training to all personnel performing activities affecting cosmetic ingredient quality. Appropriate records of training should be maintained. Training should be in the particular operations that the employee performs and in GMP as they relate to the employee's functions. The effectiveness of GMP training should be evaluated. GMP training should be revised and redelivered as changes occur to customer and regulatory requirements as well as the activities affecting cosmetic ingredient quality. GMP training on this guideline should be conducted with sufficient frequency to ensure that employees remain familiar with applicable GMP principles. Management should establish adequate and recurring personal hygiene training for all personnel handling materials so that they understand the precautions necessary to prevent contamination of cosmetic ingredients. 7.3 Awareness No additional requirements to ISO 9001:2015. The cosmetic ingredient manufacturer should ensure there is a good awareness of GMP, the importance of ingredient quality to the final cosmetic and any consequences to consumer safety of not following these requirements and the organizations procedures. Copyright 2005, 2008, The European Federation for Cosmetic Ingredients Page 15