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MODULE 5EFfCI GMP REQUIREMENTS

EFfCI AUDITOR TRAINING


• ISO 9001:2015 is a major revision of the 2008 edition.

• Although the basic principles of quality management remain the same, it brings an emphasis on the context in which the quality management system has to operate and how interested parties are involved.

2017 Edition


• For Cosmetic Ingredient manufacturers both context and interested parties perfectly align with the concepts of GMP and the protection of consumer safety.

• Risk management is another new aspect, and this was already included in the 2012 edition of the GMP Guide and Standard.

• In this respect the adoption of the ISO 9001:2015 clause structure has not introduced any significant new GMP requirements but has enhanced the integration with a QMS based on ISO 9001.

• An independent quality unit is required in the new edition

• The 2017 CI GMP remains focussed on purity controls.

2017 Edition


A significant change in the 2017 edition is the inclusion of the Standard, former Annex D, into the main text so that, for each clause

the Guidance (CI-Guidance) black test, guidance on the GMPs, why they are needed and aids implementation

andthe Standard (CI-GMP Standard)

red text, annex to ISO 9001, detailing “what to do”

can be read side by side. This should aid both understanding of the requirements and their implementation.

2017 Edition


• Changes in the 2017 edition include:– The application to distributors of cosmetic ingredients;– More emphasis that the organisation has the resources

necessary to effectively implement the GMP requirements;– If quality critical activities are outsourced these need to

comply with the cosmetic ingredient GMPs;– A demonstration of how GMPs are applied to the

manufacture and distribution of new products;– Communication of any special storage conditions on the

product label;– A definition of a significant change;– Need to define the retention period of retain samples.

• Other edits are to add clarity and aid comprehension, especially given the international use of the document.

2017 Edition


Overall organisations certified to the 2012

version of the EFfCI GMP Standard and who

have made the transition to ISO 9001:2015

should not find any difficulty in meeting the new

requirements in the 2017 edition.

2017 Edition


The 2012 edition contained the following appendices:• Appendix A Definitions and Glossary• Appendix B References• Appendix C Additional sources of Information• Appendix D GMP Standard• Appendix E Certification Scheme Rules• Appendix F Auditor Training requirements

Appendix D (“The Standard”) was used by auditors to assess cosmetic ingredient suppliers.

Former: 2012 Edition

7


In the 2017 edition these appendices have been completely revised and updated:

• Appendix A Definitions and Glossary• Appendix B References• Appendix C Additional sources of Information• Appendix D Certification Scheme Rules• Appendix E Auditor Training requirements

New: 2017 Edition

8


The 2017 edition also includes two new Appendices:• Appendix F: Clauses in Section 8 which are not

applicable to distributors.Appendix F allows cosmetic ingredient distributors to identify which parts of GMP do not apply to their activities and so allows them to implement the remaining principles of GMP to their activities

• Appendix G: Contributors to the development of the EFfCI GMP Guide and Standard.

2017 Edition

9


Preamble to this module

This module describes additional requirements to those of ISO 9001:2015. Key elements of each section of the CI-GMP Standard are summarised on the following slides. Full wording is available in the Standard.

Where you see subsections such as…

d) c) f)e) d)f)

..it signifies additional requirements over and above that of ISO 9001.

It would help if trainees read in turn each section of the EFfCI Standard as it is discussed by the trainer. This will assist in identifying the key elements of each section and hopefully prompt some questions.


Risk and opportunities

Change Control

GMP Objective

General Requirements

Records

Hygiene

Infrastructure

Environment

Management Commitment

Customer Focus

Quality Policy

uality PolicyStrategy

Organizational roles & responsibilities,

Planning and control

Control of production

Identification and traceability

Handling, storage and preservation

Change control

5. LEADERSHIP 6. PLANNING 7. SUPPORT 8. OPERATIONS

GMP requirements

Risk assessment

Chapters of ISO 9001:2008 + additional EFfCI GMP requirements (dark green)

Competence

Release of product & service

Control of N.C. outputs

4. CONTEXT of Organization


GMP Section 0Introduction

0 Introduction This section explains how the Standard is used as an annex to ISO

9001:2015. Organisations not holding a current ISO 9001 certification, assessments

against the requirements of the EFfCI Standard and ISO 9001, may be conducted simultaneously.

0.1 General Cosmetic ingredient manufacture shall be carried out in accordance with

GMP concepts consistent with this standard. 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, avoid product contamination, and ensure that appropriate records are maintained.

It includes additional requirements that support the application of GMP to the manufacture and distribution of Cosmetic Ingredients.


GMP Section 0Introduction

0.3.3 Risk based thinking Not possible to define a single set of rules which are applicable to all

cosmetic ingredients. Risk based approach is required [see module 3].

0.4 Relationship with other management system standard. The EFfCI GMP Guide and Standard is intended to be fully compatible with

ISO 9001:2015 and the ISO high level structure for management system standard (Annex SL).


Sections 1 - 3Scope, References and Terms and Definitions.

1 ScopeApplicable to all cosmetic ingredient manufacturers and distributors.

Certification is recommended to demonstrate a suitable level of GMP has been implemented.

Throughout this annex, references to “GMP for Cosmetic Ingredients” will be referred to as “GMP”.

3 TERMS and DEFINITIONS

See Appendix A.

3.1 Cosmetic Ingredient (CI)Cosmetic ingredients are substances or preparations that are intentionally included in a cosmetic product.


Section 4CONTEXT of the ORGANIZATION

4.2 Understanding the needs and expectations of interested partiesCustomers and the regulatory authorities who oversee cosmetics, as well as consumers shall be evaluated as interested parties. Monitor and review changes on their requirements.

4.3 Determining the scope of the QMS This standard includes additional requirements to ISO 9001:2015 for certification purposes. The organization shall apply ALL the requirements if they are applicable to the scope of its GMP and QMS.Requirements may be ONLY omitted if this does not adversely affect the quality of CI.The SCOPE of GMP and QMS shall be: completely covered by the scope of ISO 9001 QMS; include list of activities, facilities, product groups or products be defined and controlled as a documented information.


Section 4 (cont.) CONTEXT of the ORGANIZATION

4.4 Quality Management System and its processes 4.4.1 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).

The GMP principles outlined in this document provide a reasonable basis for the QMS used in the manufacture of CI


Section 5LEADERSHIP

5.1 Leadership and Commitment 5.1.1General

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

CI-Guidance complying with appropriate regulations and these GMP principles. Quality policy and establishment of quality objectives. Top management to review at planned intervals if resource are

adequate.


Section 5LEADERSHIP

5. Management responsibility 5.2.1 Establishing the Quality policy CI-GMP StandardTop 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

CI-Guidance Top management should demonstrate• commitment to the corporate GMP and quality policy;• support continual improvement of the quality management system with regular

review;• should participate in the development of the company's GMP and quality policy;• provide the resources necessary for its development, maintenance, and deployment.


Section 5Management Responsibility (cont…)

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.

→ to ensure freedom from conflicts of interest. The Quality Unit may comprise Quality Assurance and / or Quality Control functions.

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 and the associated risk assessments.The Quality unit shall participate in the investigation of critical deficiencies.


Section 5Management Responsibility (cont…)

5.3 Organizational Roles, Responsibilities and Authorities 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,▪ 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. Personnel whose role is critical to ensuring cosmetic ingredient quality shall

have written job descriptions.


Section 6PLANNING

6.1 Actions to address risks and opportunities CI-GMP Standard The organization shall conduct and record risk assessments as

required in the other sections of this standard. Where existing … are not considered effective then additional measures shall be implemented and these measures documented in the quality management system.

→ The effectiveness of these actions should be evaluated. R.A. 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.


Section 6PLANNING

6.1 Actions to address risks and opportunities CI-Guidance R.A. is related to cosmetic ingredient quality and consumer

safety based on the context of the organization. The use of risk assessments is indicated in the sections :

6.3 Planning of Changes7.1.3 Infrastructure7.1.4 Environment for the operating of processes8.5.1.2 Equipment Cleaning 8.4.1 Control of externally provided processes, products

and services - general8.5.4.2 Packaging Systems8.7.1 Reprocessing/Reworking


Section 6 PLANNING

6.2 Quality Objectives and planning to achieve themTop Management shall set objectives to maintain and improve compliance to GMP. (measurable and their periodic review).

6.3 Planning of ChangesCI-GMP Standard 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.

CI-Guidance 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.


Section 7SUPPORT

7.1 ResourcesIdentify resource requirements → gap analysis + internal audits.

7.1.1 GeneralCI-GMP Standard

The organization shall consider the:c) GMP requirements of this standard.

CI-GuidanceTop management should provide sufficient resources, e.g.:o people, o Equipmento Materialso Buildingso Facilitiesto 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.


Section 7SUPPORT

7.1.2 PeopleCI-GMP Standard

The organization shall determine and provide the persons necessary for the effective implementation of GMP.


Section 7SUPPORT

7.1.3 Infrastructure CI-GMP Standard

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 :➢ location of the operations (e.g. internal, external),➢ state of repair of the building and facility,➢ suitable size, construction and location,➢ ability to maintain a suitably clean building and facility environment,➢ operations that can affect the cosmetic ingredient quality,➢ presence of airborne contaminants, especially highly sensitizing or toxic substances. Where existing controls … 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.


Section 7 (cont.)SUPPORT – 7.1 Infrastructures

CI Guidance: The following subsections provide more detailed guidance on the specific aspects related to infrastructure. 7.1.3.1 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- 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. Also adequate facilities for the testing of raw materials, packaging components, intermediates, and finished cosmetic ingredients.

7.1.3.2 Equipment As above.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).



7.1.3.2.1 Equipment construction Contact surfaces will not be reactive, additive, or absorptive and thus not alter the quality of the cosmetic ingredient.Substances required for operation (lubricants or coolants) should not come into contact with raw materials, packaging materials, intermediates, or finished cosmetic ingredients unless technically unavoidable. 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.

7.1.3.2.2 Equipment maintenance Written procedures 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.


Appropriate GMPFor cosmetic ingredient Manufacturers

Review the photographs and identify the GMP issues

State your reasons why the issues are not EFfCI GMP compliant


Appropriate EFfCI GMPFor cosmetic ingredient Manufacturers ?









7.1.3.2.3 Computer systemsUsed in the manufacturing and/or testing of C.I. 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 7.5.3.2).



7.1.3.3 Utilities used in manufacture of cosmetic ingredientsUtilities (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.

7.1.3.4 Water used in manufacture of cosmetic ingredientsWater 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, at a minimum, meet World Health

Organization (WHO) guidelines for drinking (potable) water quality. ➢ If drinking (potable) water is insufficient to assure quality, 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.


Section 7SUPPORT

7.1.4 Environment for the operating of processesCI-GMP Standard

Managed to minimize risks of cosmetic ingredient contamination.To determine the necessary controls, a documented risk assessment shall cover the following controls, as applicable:▪ air handling systems, (e.g. Heating, Ventilation and air conditioning -

HVAC), ▪ special environments, ▪ cleanliness and sanitary conditions,▪ waste segregation and disposal,▪ pest control, ▪ other risk assessments required by this Standard.Where maintenance of the work environment is critical to cosmetic ingredient quality, the controls shall be documented.


Section 7SUPPORT

7.1.4 Environment for the operating of processesCI-Guidance

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.

7.1.4.1 CleaningImportant consideration in the design and operation of C.I. manufacturing facilities. Buildings (…) 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.








Section 7SUPPORT - 7.1.4 Environment for the operating of processes - Subsections

CI-Guidance

7.1.4.2 Pest ControlRisk assessment → to determine the need for pest control and its extent (where the C.I. is at risk of contamination from pests) Also an assessment of the chemicals used in the programme and the threats these may pose.Some starting materials (e.g. botanicals) may contain unavoidable contamination(rodent, other animal filth/ infestation). Control methods to prevent the increase of contamination or infestation in holding areas, or its spread to other areas of the plant.

7.1.4.3 LightingAdequate light to facilitate cleaning, maintenance, operations and testing.→ !!! Hazards posed from glass lighting included in the risk assessment.

7.1.4.4 DrainageWhere C.I. is open to the environment, drains should be of adequate size and be provided with an air break or other mechanical device to prevent back siphoning.




Section 7SUPPORT - 7.1.4 Environment for the operating of processes - Subsections

CI-Guidance

7.1.4.5 Personnel hygieneWhere C.I. 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 or similarrestricted to certain designated locationsseparate from manufacturing areas.

7.1.4.6 Washing and toilet facilitiesAdequate 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.


Section 7 (cont.) Product realisation

7.2 CompetenceCI-GMP Standard

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.CI-Guidance For personnel performing work affecting the quality of cosmetic ingredients:

▪ appropriate education, training and/or experience,▪ job descriptions including the competencies required for the duties performed,▪ identify and provide the necessary training in the particular operations and in GMP

as they relate to the employee's functions. Appropriate records of training should be maintained. The effectiveness of GMP training should be evaluated. GMP training should be revised and redelivered - changes occur to customer, regulatory

requirements and activities. GMP training with sufficient frequency: employees remain familiar with applicable GMP

principles. Adequate and recurring personal hygiene training for all personnel handling materials to

prevent contamination of cosmetic ingredients.


Section 7 (cont.)Product realisation

7.4 Communication

CI-GMP StandardGMP and regulatory requirements shall be communicated as appropriate throughout the organization.Top management shall be notified in a timely manner of quality critical situations, such as recall or withdrawal of cosmetic ingredients, in accordance with a documented procedure.



7.5 Documented Information 7.5.2 Creating and updating DOCUMENTS

CI-GMP StandardDocuments that impact product quality shall be reviewed and approved by the Quality Unit.The retention period of obsolete documents shall be defined. The Quality Unit shall securely retain at least one copy of obsolete documents. If electronic signatures are used on documents they shall be controlled to provide equivalent security to that given by a hand written signature.



7.5 Documented Information 7.5.2.2 Creating and updating RECORDS

CI-GMP StandardEntries in quality records shall be clear, indelible and made directly after performing the activity (in the order performed). Quality records and any corrections made to them shall be traceable.

CI-GuidanceProcedures for the identification, collection, indexing, filing, storage and maintenance of quality records (log, computer database, or other appropriate documentation).Quality records should be legible and traceable to the product involved. Pertinent subcontractor quality data should be an element of these records.Entries: clear, indelible, made directly after performing the activity (in the order). 7.5.3.2 Control of documented information

CI-GMP Standard Quality records shall be kept for a defined period. The period shall be justified. For batch records, this period shall not be less than one year past the cosmetic ingredient expiry or original retest interval.




Section 8OPERATION

8.1 Operational planning and controlCI-GMP StandardThe organization shall plan, implement and control the processes (see Section 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in clause 6 by:

f) written testing programs for cosmetic ingredients that include specifications, sampling plans, test and release procedures,

g) defined testing or other appropriate controls for quality critical materials,h) environmental, contamination and hygiene control programs, andi) requiring that contract manufacturers or laboratories adhere to the relevant sections of this Standard.

CI-GuidancePlans and controls should be appropriate to the process, cosmetic ingredient specification, the risks identified and the equipment and facilities used in the manufacture of the product.Records: provide evidence that these plans have been realised as intended and enables traceability to be demonstrated.


Section 8 OPERATION

8.5.1 Control of Production and service provisionCI-GMP Standard

Controlled conditions shall include, as applicable:i) Production instructions and records,j) Equipment cleaning,k) Recovery of solvents and similar activities,l) In-process mixing and blending,m) In-process control,n) Packaging and labelling, ando) Records of equipment use.The organization shall identify the need for and justify equipment cleaning and where used, sanitization procedures and provide evidence of their effectiveness. The effectiveness of cleaning procedures shall be re-evaluated after significant changes.


Section 8 OPERATION

8.5.1 Control of Production and service provisionCI-GMP GuidanceSpecific examples of controls that are important are illustrated in the following sections.Not all of these may be applicable to all cosmetic ingredient manufacturers.

8.5.1.1 Production instructions and records Batch vs. continuous.Production instructions: prepared for each cosmetic ingredient, accurate reproduction issued to the production area.Where manufacturing processes run entirely on automation and are computer controlled, then there should be a defined and restricted access to changing those settings.Records should be available for each batch: include information relating to the production and control of each batch. Records may be in different locations but should be readily retrievable.


Section 8 OPERATION - 8.5.1.1 Production instructions and records

Records should include, where critical to C.I. quality, documentation that each significant step in the manufacture, processing, packing, or holding of the batch has been accomplished, for example: ➢ date/time each step was completed,➢ identification of individual major equipment and lines used,➢ specific identification of each batch of component or in-process

material used,➢ weights and measures of components used in the course of

processing,➢ in-process and laboratory control results,➢ a record of the inspection of the packaging and labelling area before

and after use,➢ ….. follow next page….


Section 8 OPERATION - 8.5.1.1 Production instructions and records

….. Records should include….., for example:

➢ a recorded statement of the actual yield or quantity produced and a statement of the percentage of theoretical yield,

➢ labelling control records,➢ description of cosmetic ingredient product containers and closures,➢ description of sampling performed,➢ identification of persons performing or supervising the operations or

checking each significant step in the operation,➢ a record of investigations made for failures and discrepancies,➢ results of final product inspection.


Section 8 OPERATION - 8.5.1 Control of Production and service provision - subsections

CI-GMP Guidance 8.5.1.2 Equipment Cleaning

▪ A risk assessment identifies the need for equipment and utensils cleaning and/or sanitisation procedures.

▪ Documented procedures with sufficient details to allow operators to clean each type of equipment in a reproducible and effective manner.

▪ Evidence of the effectiveness available; to be re-evaluated after significant changes.

▪ Appropriate intervals to prevent contamination of the cosmetic ingredient. The cleaning status of equipment should be recorded appropriately.

▪ Multipurpose equipment: to be able to determine previous usage when investigating (possible) cross-contamination.

▪ Production campaign: incidental carryover is acceptable.▪ For continuous processing the frequency of equipment cleaning should be

determined by the manufacturer and justified.









CI-GMP Guidance 8.5.1.3 Recovery of Solvents, mother liquors and second crop crystallizationThey meet defined quality standards prior to reuse or mixing with other approved material. Documented in the batch production records to enable traceability

8.5.1.4 In-process blending/mixingTo assure batch uniformity or to facilitate processing: should be adequately controlled, documented and be reproducible from batch to batch (see also Section 8.7.1).

8.5.1.5 In-process control▪ Monitoring the process or actual sample analysis at defined locations and times.▪ Sampling methods documented, the sample is representative and clearly labelled.▪ The results recorded and conform to established process parameters or acceptable

tolerances.▪ Defined actions to be taken when the results are outside specified limits.



CI-GMP Guidance 8.5.1.6 Packaging and labelling

▪ To protect the quality and purity of the cosmetic ingredient when it is packaged, and the correct label is applied to all containers.

▪ Packaging and labelling operations should be designed to prevent mix-ups.▪ Procedures to ensure the correct labels are printed, issued and contain the

correct information; any excess labels are immediately destroyed or returned. All excess labels bearing batch numbers should be destroyed.

▪ Packaging and labelling facilities inspected immediately before use to ensure that all materials that are not required for the next packaging operation, have been removed.

▪ Where cosmetic ingredients are labelled on the packaging line, packaged in pre-printed bags, or bulk shipped in tank cars, there should be documentation of the system used to satisfy the intent of the above principles.



CI-GMP Guidance

8.5.1.7 Record of equipment useRecords of quality critical equipment used, to allow the sequence of cleaning, maintenance and production activities to be determined.

8.5.1.8 Validation of processes for production and service provision (As ISO 9001) Validation of the manufacturing processes used for cosmetic

ingredients is not necessary as the product quality can be adequately determined at the end of processing. Where this determination is not possible, the manufacturing process should be validated.




Section 8OPERATION

8.5.2 Identification and traceabilityCI-GMP Standard

Identification and traceability are specified requirements; the quality management system shall include records that allow traceability of the cosmetic ingredient to raw materials and upstream to customers.If defined storage conditions are required to ensure cosmetic ingredient quality these shall be stated on the label.


Section 8OPERATION - 8.5.2 Identification and traceability

CI-GMP Guidance 8.5.2.1 Traceability

➢ Quality critical items (raw materials, packaging materials, intermediates, and finished C.I.) clearly identified and traceable - through a documented system –downstream to raw materials and upstream to customers.

➢ Continuous processing: identification of batches present in the equipment at a designated point in time.

➢ Raw materials (solvents )stored in bulk tanks or other large containers: precise separation of batches difficult. Nevertheless, should be documented in production records. 8.5.2.2. Inspection and test status

➢ System to identify the inspection status of quality critical items.➢ Continuously-fed materials may need special consideration in order to satisfy

these requirements.


Section 8OPERATION - 8.5.2 Identification and traceability

CI-GMP Guidance 8.5.2.3 LabellingLabelling requirements for C.I. packages are subject to national and international regulatory requirements, which may include transportation and safety measures. At a minimum, labels should include:

➢ the name of the cosmetic ingredient, and grade if applicable,➢ the cosmetic ingredient manufacturer’s, and/or distributor’s name,➢ the batch number from which the complete batch history can be

determined,➢ if special storage conditions are required, such restrictions should be

placed on the label or otherwise communicated to the customer with the consignment.




Section 8OPERATION - 8.5.4 Preservation

8.5.4.1 Handling, storage, and preservationCI-GMP Standard

If defined storage conditions are required to ensure cosmetic ingredient quality these shall be stated on the label or otherwise communicated to the customer. Records of storage conditions shall be retained for cosmetic ingredients requiring defined storage conditions.

CI-GuidanceCosmetic ingredients, intermediates, and raw materials should be handled and stored under appropriate temperature, humidity, and light conditions, so that their identity, quality, and purity is not affected. Outdoor storage of raw materials (e.g., acids, other corrosive substances, or explosive materials) is acceptable provided the containers give suitable protection to their contents, identifying labels remain legible, and containers are adequately cleaned prior to opening and use.


Section 8OPERATION - 8.5.4 Preservation

8.5.4.2 Packaging systemsCI-GuidanceA cosmetic ingredient packaging system should include the following features:▪ written specifications, examination or testing methods, ▪ cleaning procedures where containers are re-used,▪ adequate protection against deterioration or contamination of the cosmetic

ingredient that may occur during transportation and recommended storage,▪ application of tamper evident seals to assure product integrity,▪ storage and handling procedures which protect containers and closures and

minimise the risk of contamination, damage or deterioration, and which will avoid mix-ups (e.g., between containers that have different specifications but are similar in appearance).

▪ a written justification that the packaging does not introduce impurities to the cosmetic ingredient,

▪ When containers are re-used, all previous labelling should be removed or defaced.








Section 8OPERATION

8.5.6 Control of changesCI-GMP Standard

There shall be a documented procedure defining the responsibilities and requirements for the evaluation and approval of changes that may impact the quality of the cosmetic ingredient. The procedure shall define:

➢ what constitutes a significant change, ➢ which as a minimum are those that alter the quality of the cosmetic ingredient,

its performance, regulatory status, or the claims made about the cosmetic ingredient.

➢ Evaluation and approval of changes shall occur prior to the implementation.➢ The quality unit shall evaluate changes that may impact on the quality of the

cosmetic ingredient. ➢ Where the impact of the changes is significant, such changes shall be

communicated to customers.➢ Records of the change control process shall be retained.


Section 8OPERATION

8.5.6 Control of changesCI-Guidance

Significant changes: those that alter the GMP or quality management system status, the quality of the cosmetic ingredient, its performance, regulatory status, the services provided, or which may impact or change the known claims made by the customer in their use of the cosmetic ingredient.

Examples of significant changes could be:❖ the origins of raw materials,❖ the cosmetic ingredient formulation, recipe or composition❖ packaging of the ingredient,❖ specifications,❖ test methods,❖ production processes,❖ manufacturing or packaging sites,❖ changes to regulatory status etc.


Section 8OPERATION

8.6 Release of products and servicesCI-GMP Standard

Written procedures shall be established to monitor and control the quality characteristics of C.I. These shall include, as applicable:

➢ Laboratory controls,➢ Cosmetic ingredient testing and release,➢ Out-of-specification test results,➢ Retained samples,➢ Certificate of Analysis,➢ Impurities,➢ Stability, and➢ Expiry/Retest periods.


Section 8OPERATION

8.6 Release of products and servicesCI-GMP Standard Records of in-process and final cosmetic ingredient testing shall be retained

and shall identify the person performing the tests and the dates the tests were performed.

The Quality Unit shall be responsible for the content and approval of Certificates of Analysis.

The organization shall evaluate cosmetic ingredient stability based on historic data or specific studies. The organization shall define and justify an expiry or retest interval and ensure this is communicated to the customer.

Samples shall be kept for a defined period. The period shall be justified.


Section 8OPERATION

8.6 Release of products and servicesCI- Guidance

8.6.1 Laboratory controls

8.6.2 Cosmetic ingredient testing and release

8.6.3 Out-of-Specification test results

8.6.4 Retained samples

8.6.5 Certificates of Analysis

8.6.6 Impurities

8.6.7 Stability

8.6.8 Expiry/Retest periods


Section 8OPERATION

8.7 Control of non-conforming outputsCI-GMP Standard

The organization shall deal with nonconforming product by one or more of the following ways:e) by blending, reprocessing or reworking. Where this is not a normal part of

the manufacturing process it shall be documented in a batch record to ensure traceability, and

f) By defining procedures for the holding, testing, and reprocessing of the returned cosmetic ingredient. Records of returned products shall be maintained.

Procedure defining how to trace a batch of a material and manage a recall (withdrawal) of a cosmetic ingredient. The ability to perform traceability of a material shall be tested at least annually.


Section 8OPERATION

CI- Guidance 8.7.1 Reprocessing/Reworking

Blending, reprocessing or reworking not a normal part of the manufacturing process → documented in batch record to ensure traceability.

Reprocessing/reworking: review of risk to cosmetic ingredient quality, considering: new impurities as a result of the reprocessing/reworking, additional testing to control the reprocessing/reworking, establishment of suitable acceptance criteria for the reprocessed/reworked cosmetic

ingredient, performance.

Evaluate and document the equivalence of the quality of reprocessed/reworked material to original material, to ensure that it will conform to established standards, specifications, and characteristics.


Section 9 PERFORMANCE EVALUATION

CI-GMP Standard 9.2 Internal audit

The internal audit programme shall include information on whether the quality management system conforms to the requirements of EFfCI GMP.

9.3 Management review 9.3.1 GeneralThe review of the performance of the quality management system shall include EFfCI GMP.

9.3.2 Management review inputThe management review shall be planned and carried out taking into consideration:c) information on the performance and effectiveness of the quality management system

including trends in:

8) conformance to the requirements of EFfCI GMP.


EFfCI Standard vs. ISO 9001 Conclusion

Many requirements are the same Commitment to GMP policy, QA manual, communication to customers Use of risk assessments to determine controls needed during

production of the ingredients Enhances role of quality unit in regard to

Reviewing and approving quality documents Batch release Change control

Requirement to define specific responsibilities Supplier approval Raw materials, packaging release for use Batch release…


EFfCI Standard vs. ISO 9001 Conclusion

Additional requirements for documented procedures Out of specification test results (management, investigations, conclusions), Retained samples, Impurities, stability Reworking Product recall

Additional requirements for records Clarity, traceability of person performing activity, Record retention periods, returned goods

Change control system Emphasis on control of work environment to prevent contamination Traceability is not optional Raw material and packaging specifications


MODULE 6

CLASSIFICATION AND WRITING OBSERVATIONS



Classification/Definitions

Within the ISO 9001 system there are two classification, Major and Minor: The ISO definition of a MAJOR nonconformity:

• Total breakdown of system, control, or procedure• Absence of an ISO 9001 requirement• A number of minors related to the same clause• A nonconformity that would result in probable shipment of nonconforming product• A condition that may result in the failure or materially reduce the usability of product

for intended purpose• A nonconformity that experience and judgement indicate will likely result in QMS

failure or materially reduce its ability to assure controlled processes and products

EFfCI follows the same definitions of Major and Minor• Where consumer safety is at serious risk or significantly compromised then the issue

is Major• A failure to identify a serious hazard and take steps to mitigate the risks would be a

Major


Minor

The ISO definition of a MINOR nonconformity:

Failure to conform to a requirement which (based on judgement and experience) is not likely to result in QMS failure

A single observed lapse or isolated incident Minimal risk of nonconforming product or service Significant numbers of related Minor observations can be grouped

together to be classified as a Major observation Similarly for EFfCI

Where consumer safety is not at serious risk Where the matter is failure to comply with procedures but which has no

other impact on the cosmetic ingredient


Examples of observations

Some of them may be Minor or Major depending on the context: No change control for the production process QC Lab furnace not in the calibration program There is no SOP describing the pest control program. Whiteout and one overwrite in one lab notebook. No cleaning SOP for dedicated equipment. Scale calibration not being performed over full range of

use. No periodic review of SOPs Although activities are performed there is no SOP in place No calibration SOP for the temperature gauge


Be objective and never subjective Observations should be factual, accurate and justifiable Stick to the “who”, “what”, “where” and “when” Use “why” only when absolutely necessary to enhance meaning, and

support this with facts Avoid personal opinion and commentary, especially in audits Avoid universal statements such as:

“All”, “Never”, “Always”, “Every”, “Generally”

Do not draw legal conclusions based on your interpretation of the facts Avoid offering opinions on compliance.

Writing Observations - 1


Be specific: identify precise situations and facts. Do not make inflammatory, gratuitous or judgmental statements. Avoid words with “shock” value to highlight issues; use other

avenues to focus attention. Quote the clause of the standard which has not been satisfied. Attempts to explain what a document means after the fact are

usually ineffective.

Writing Observations - 2


Phrases for Consideration

It was noted that…

It was reported that…

It was observed that…


Example of a Good Observation

Raw material controls are inadequate. For example, identity testing is not performed on raw materials destined for finished cosmetic products, no testing of product contact nitrogen even on a periodic basis. Supplier audits or corporate supplier approval documentation are not available as required by supplier approval SOP xxx/y.

As required by EFfCI Standard xxx and yyy CONFIRM CLAUSE REFs


Examples of Bad Observations

In-process Quality Control procedure, sample evaluation, manufacturing records review and final approval of the batch is carried out at present but the whole process requires proper integration and improvement

Pressure gauge on the reactor was showing an OOS result without attention of the responsible personnel.


In Conclusion

Be truthful – anything less could lead to “knowing and intentional” violations Your knowledge of the standard is invaluable Do not hesitate to identify factual issues Create a factual record

Be aware of unintended consequences of your communications.

Writing the report Write up the report as soon as possible after the audit Use your own companies format for the report It is good practice to ask the auditee to check for factual correctness.


Workshop Exercise

Form into your Teams and evaluate these observations based on the potential risks for the quality of cosmetic ingredients and additional questions you need to conclude

Justify your rating on the potential risks. What additional information you need to conclude? Which corrective actions to be taken?

Each group should justify their decision.


Workshop Exercise

Observation Set 1 What arethe risk?Addtionalinformation needed to classify?

Clause?

There were gaps under all of the doors in the filling area thatcould potentially lead to infiltration of pests.Potable water – although a testing program for potable waterexists, the program does not take into account the WHO requirementsIn the Carbon black processing area, there was a scale that wasencrusted with product so much as to reduce its effectiveness. Also, this equipment did not have a calibration sticker on it.


Workshop Exercise


Clause?

Some pallets of finished products were found stored in the same location as raw materials due to the insufficient place. There is no segregation area for rejected raw materials

Raw materials containers stored outside were found dusty

No dedicated area for sampling raw materials

The calibration of the brookfield viscosimeter is outsourced. There is no verification by the lab that the calibration covered the range of the intended use The change control was found closed without checking that actions have been effectively implemented


Workshop Exercise


Clause?

The reagents of the lab were not found labeled with an expiry date

Delegations of responsibility are not defined in any document

Deviations are not investigated to research the root cause

Suppliers of raw materials and key contractors are not evaluated

Instruction related to gowning instructions were found not properly respected: the coats were not changed as it is required, the cap of some operators did not cover properly hairsThe OOS investigation was not documented. Retest was performed. Batch was released based on results of retests


Workshop Exercise

Observation Set 4 Rating?What are the risk?Addtionalinformation needed to classify?

Clause?

A computerized system is used for the management of materialstatus; during the audit, it was observed that many people in the company has the authorization of material releaseThe product during the filling operation was found not protected

One equipment was found identified with obsolete bulk information.

The cleaning procedure did not contain details related to the cleaning agent, contact time of cleaning agent…No evidence of training record for equipment cleaning operation

Some documentations are not under control. So some instructions were found obsolete. Archiving period was defined independently of the product's shelf-life


MODULE 7

MOCK AUDITS



Audit Completed by Allan Whiston (Lead auditor, QAR Ltd)Marie Cecile Krief (HCS-QA)


Purpose, Scope and Audit Standard

Purpose To perform an EFfCI certification audit of Cosmetic Ingredient Inc

Scope Manufacturing of glycerol

Audit Standard EFfCI GMP for Cosmetic Ingredients – Certification Scheme - Revision

2017

It is vital that there are appropriate risk assessments in place. Any perceived NC by an auditor should be subject to the following questions:What is the risk? and What is the consequence to the user of the NC?


After the audit

Audit report will be distributed within 20 working days

Cosmetic Ingredient Inc must provide a written response to findings within 20 working days following issuance of the audit report


Any questions?


FINAL THOUGHTS



Final Thoughts on Auditing

Be Observant Anything out of place? Items not stored properly? Question the basics

◼ Source of water◼ Sanitary plumbing◼ Retention of test data

◼ Ask about printouts from instruments◼ Review lab notebooks.


Final Thoughts on Auditing

Be Observant Unprotected lights Review procedures and look for:

◼ Commitments difficult to implement◼ Incomplete implementation

◼ Critical raw materials◼ Audit critical suppliers.


Next steps

Attendance certificates will be given out on completion of this course and final testing.


Thank you

for your attention

and

good auditing!

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