EFfCI GMP Training - ASPA...

1EFfCI GMP Training <Venue> <Date>


Course Rules (Please don’t forget them!)

Rule 1 – stay safe!

Rule 2 – You are now in a no-risk environment. Throw caution to the wind!

Rule 3 – Those who risk nothing gain nothing! Feel free to participate to the degree with which you are comfortable

Rule 4 – Be curious. Go ahead, ask questions. There is no such thingas a silly question!

Rule 5 – We, as trainers, may not have all of the answers, but, if we cannot answer your question we will get back to you

Rule 6 – We try to learn at least one new thing each day. Please do the same.


Trainer

Dr. Iain MooreGlobal Head of Quality AssuranceCroda International [email protected]

Dr. Marco VassalloCEOComplife Italia S.r.l.- [email protected]


Who are you?

Name

Company, function and years service

GMP / Audit Experience (if any)

What you expect from this course


Course Content

Introduction Module 1 – EFfCI presentation Module 2 – GMP for Cosmetic Ingredient Module 3 – Risk Management Module 4 – When Does GMP start? Module 5 – EFfCI GMP Requirements Module 6 – Classification and Writing Observations Module 7 – Mock audit Module 8 – Exam and wrap up


INTRODUCTION

EFfCI GMP AUDITOR TRAINING


GMP for Cosmetic Ingredients Requirements of the Customers

What else do retailers and consumers require ?• A continuously safe product• A legal product• Products which are in line with independent consumer

testing, such as „Stiftung Warentest“ and/or „Ökotest“ the Campaign for safe cosmetics

• A product not listed in the „RAPEX“-System http://ec.europa.eu/consumers/dyna/rapex/rapex_archives_de.cfm• No system like this in the US (yet)

http://ec.europa.eu/consumers/dyna/rapex/rapex_archives_de.cfm



RAPEX is the EU rapid alert system for dangerous consumer productsExample 1:Category: CosmeticsProduct: Shampoo/shower gelBrand: HimalayaType/number of model: Batch No: 292382010Description: Shampoo/shower gel (milky-white herb-scented viscose liquid)

in a white plastic bottle with blue flip-top lid, 250 ml.Bottle reads, in German: "For hair and body with Aloe Vera,Neem, grapeseed oil„

Country of origin: Germany MicrobiologicalThe product poses a microbiological risk because of the presence of aerobic mesophilic bacteria at a count of 1.1 x 106 and 19 x 106 CFU/g. The liquid contains: Enterobacter cloacae, Citrobacter freundii, Klebsiella pneumoniae ssp. Pneumoniae,Pseudomonas putida.The product does not comply with the Cosmetics Directive. Voluntary withdrawal from the market and recall from consumers by the manufacturer.


RAPEX

Example 2:

Alert number: A12/1006/17

Category: Cosmetics

Product: Cream for babies

Brand: Cotton Tree

Name: Zinc and Castor Oil Cream

Type / number of model: Batch No (Expiry Date): Zc 518 (11/2018); Zc 607 (04/2019); Zc 602 (02/2019); Zc 603 (02/2019); Zc 604 (02/2019); Zc 609 (06/2019); Zc 614 (09/2019)

Batch number / Barcode:5050375062726

Risk type: Chemical

This product contains 0.1% of propylparaben. This paraben has a potential endocrine disrupting activity. The product does not comply with the Cosmetic Products Regulation.

Measures taken by economic operators: Withdrawal of the product from the market (By: Distributor)


Alert number: A12/0851/17

Category: Cosmetics

Product: Make-up remover

Brand: LUMI

Name: Make-up remover

Type / number of model: Item 1155

Batch number / Barcode: 4744034013334

Risk type: Microbiological

The product contains mesophilic aerobic bacteria (measured quantity 7.8x10<sup>4</sup> cfu/ml). If used on damaged skin or if it comes into contact with the eyes, the product may cause infection or irritation. The product does not comply with the Cosmetic Products Regulation.

Measures taken by economic operators: Warning consumers of the risks, Withdrawal of the product from the market (By: Manufacturer)

Example 3:



Example 4:

Serious Consumer 2014 - 8 14

A12/0311/14 France

Category:Cosmetics Product: Nail gel Brand: Nails by JM (Jean Marin) Name: Builder Gel Type/number of model: 4604724 medium white Batch number/Barcode:1239/01/5 446 899 053 740 OECD Portal Category: Beauté / Soin Personnel / HygièneDescription:Modelling nails gel, to strengthen nails. it is presented in a white, round plastic box. Country of origin:Belgium

chemical The product poses a chemical risk because it contains Antimony (219mg/kg). The product does not comply with the Cosmetic Products Regulation.

Voluntary measures: Withdrawal of the product from the market

http://ec.europa.eu/consumers/safety/rapex/alerts/main/index.cfm?event=main.weeklyOverview&web_report_id=891


Past Issues

2006 : warning letter related to a violative use of additive canthaxanthine

2006 : warning letter related to the content of 28% of color additive p-

phenylenedimine

2009: warning letter due to product considered and manufactured under

insanitary conditions

2011: warning letter related to the content of more than 10% of methylene

glycol, liquid form of formaldehyde

2014 : FDA recall of eyeliners manufactured in Pakistan due to elevated

lead content


Regulations for Cosmetic finished products

Risks in the manufacture of Cosmetic Finished Products are mitigated by ISO 22716:2008 and underpinned by the EFfCI GMP Standard 2012.

Covered by Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA Draft Guidance for Industry: Cosmetic Good Manufacturing Practices (in which they agree to Consider ISO 22716)



What do our customers expect?• FD&C and FPL Acts• EC Cosmetic Regulation 1223/2009• QM System ISO 9001• Cosmetic GMP ISO 22716• RAPEX : warning system (EU)


Standards which are relevant for your customers?• FD&C Act applies in the USA but is not proscriptive on GMPs • Cosmetic Regulation EC 1223/2009 is focusing on forbidden

substances, preservatives, colours, link to GMP, technical data, documentation,….

• ISO 9001 well known process focused QM Standard dealing e.g. with requirements on documents, Management Review, Quality Policy, Continuous Improvement, Management of Resources, Customer Focus, R&D, Supplier Assessment

• Cosmetic GMP ISO 22716 Standard for Cosmetic Producers considering personnel and production hygiene, equipment, storage, raw materials, production process, tests, contract manufacturing…

USA - GMP for Cosmetic Ingredients Requirements of the Customers


China - IECIC

IECIC: Inventory of Existing Cosmetic Ingredients in China

The IECIC is the official inventory by CFDA1, which lists the ingredients allowed for use in cosmetic products sold in China

Ingredients used in finished cosmetic products sold in China must be listed in the IECIC. This requirement applies to cosmetic products manufactured in China and other parts of the world

8783 entries at end of 2015

1 CFDA: China Food and Drug Administration.


China - IECIC List


Finished cosmetics are divided into 2 classes ordinary cosmetics and special use cosmetics

with each requiring a different license

Finished cosmetics manufacturers are responsible for the classification of their products and the application of the relevant licenses

Ingredients listed in IECIC can be used in both cosmetic classes.

China - Finished Cosmetic Management


Type of Product Required License1 Authority

Domestic Ordinary CosmeticsThe cosmetic products except for special use cosmetics

Online record–keeping

Provincial FDA

Imported Ordinary Cosmetics2

The cosmetic products except for special use cosmetics

Record-keeping Certificate

CFDA

Special Use CosmeticsProducts for hair growth, hair dye, hair perm, hair removal, breast shaping, fitness, deodorizing, spots removal (including whitening), sun block

Hygiene License CFDA

1 These licenses are required by cosmetic manufacturers2 Imported Ordinary cosmetics approval will be transferred to Provincial FDA

step by step in future, Imported Ordinary cosmetics imported from Pudong,

Shanghai, can be recorded in Shanghai.

China - Finished Cosmetic Management


China - Cosmetics Technical Safety Standard (2015 version)

1. It is mainly for finished products 2. Come into effect from Dec 1st, 2016 3. New limit for hazardous substances

2.

4. Amendments to hazardous ingredients

Hazardous substance 2015 version (mg/kg) 2007 version (mg/kg)Mercury 1 1Lead 10 40Arsenic 2 10Cadmium 5 /Methanol 2000 2000Dioxane 30 /Asbestos No detectable /

2015 version 2007 versi2007

Forbidden component 1388 1286Permitted antiseptic 51 56Permitted sun screening agent 27 28Permitted coloring agent 157 156Permitted hair dye 75 93restricted component 47 73


China - Cosmetics Technical Safety Standard (2015 version)

CurrentWash offMaximum Permitted(% active)

NewWash off Maximum permitted(% active)

CurrentLeave onMaximum permitted(% active)

NewLeave onMaximum permitted(% active)

▪ Cetrimonium Chloride (CTC) and Steartrimonium Chloride (STAC)

▪ For the individual concentrations or the sum of the individualconcentration of CTC and STAC.

No limit 2.5 0.25 0.25

▪ Behentrimonium Chloride (BTMC) --For the individual concentration of BTMC or the sum of the individual concentrations of CTC, STAC and BTMC,

▪ (while at the same time respecting the relevant maximum concentration for the sum of CTC and STAC)

No limit 5.0 0.25 0.25

Example of entry Very similar in principle and style to European regulatory

approaches


Standards which are relevant for your customers?• China has drafted GMP for cosmetics• FD&C Act applies in the USA but is not proscriptive on GMPs • Cosmetic Regulation EC 1223/2009 is focusing on forbidden

substances, preservatives, colours, link to GMP, technical data, documentation,….

• ISO 9001 well known process focused QM Standard dealing e.g. with requirements on documents, Management Review, Quality Policy, Continuous Improvement, Management of Resources, Customer Focus, R&D, Supplier Assessment

• Cosmetic GMP ISO 22716 Standard for Cosmetic Producers considering personnel and production hygiene, equipment, storage, raw materials, production process, tests, contract manufacturing…



Verification of EFfCI GMP

How can the cosmetic manufacturer confirm their

cosmetics are made to GMP if the ingredients do not

also follow the principles of GMP in their manufacture?

Through questionnaires?

Site Audits?

Supporting evidence (e.g. review of historical data)?

Third Party Audits?


6 Raw materials and packaging materials6.2 Purchasing Purchasing of raw materials and packaging materials

should be based on:a) evaluation and selection of the supplier;b) establishment of technical clauses such as type of selection to be conducted, acceptance criteria, actions in the case of defect or modifications, transport conditions;c) setting of relations and exchanges between the company and supplier such as questionnaire, assistance and audits..

What does ISO 22716 say about supplier qualification?


Issues with Physical Audits

Not enough auditors or days in the year to audit all of the suppliers

Dilutes resources from assessing higher risks

Suppliers could face 100s of audit requests a year –so will refuse to host many

Supplier Qualification


Knowing your suppliers and mitigating risk

The current nature and challenges facing ingredient supplier audits, ingredient supplier qualification, assessment and certification

The role of EFfCI in supplier qualification.

EFfCI Certification


MODULE 1

EFfCI PRESENTATIONRequirements for

Cosmetic ingredients



EFfCI European Federation for Cosmetic Ingredients

✓ European trade association representing the chemical and natural ingredient industries, as well as the suppliers and service providers for the cosmetic industries;

✓ more than 100 Companies in Europe;✓ 6 national Associations:

✓ direct members in other european countries:(Austria, Belgium, Spain, The Netherlands, Switzerland)

http://www.irisressources.com/accueil.php



The quality of cosmetic ingredients is critical to assure the safety, quality and efficacy of cosmetic 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.

The underlying idea of the EFfCI GMP Standard for Cosmetic Ingredients is to provide manufacturers with a tool for implementing an appropriate and workable risk based GMP system.

Why EFfCI GMP?


Acceptance and support by all stakeholders

International: certification accepted globally

Certification accessible for as many accredited 3rd party organizations as possible A key requirement of the scheme is to demonstrate the competence of the

auditors

Evolutionary: builds on existing guides and standards

Simple: easy to understand and apply for all stakeholders

Inclusive: applicable to as many ingredients as possible in consideration of economical aspects

Permits the Supplier to proactively demonstrate commitment to cosmetic ingredient GMP in the manufacture of their ingredient.

The EFfCI Goals


Focuses on the ingredient supplier’s quality management system rather than individual ingredients

Auditor Competency Requirements

Scheme rules

EFfCI Structure


Personal Care Products Council

Based in Washington, D.C., the Personal Care Products Council is the leading national trade association representing the global cosmetic and personal care products industry.

Founded in 1894, the Council's more than 600 member companies manufacture, distribute, and supply the vast majority of US finished personal care products.

1894: Manufacturing Perfumers’ Association 1922: Manufacturers of Toilet Articles 1933: Associated Manufacturers of Toilet Articles 1936: Toilet Goods Association (TGA) 1972: Cosmetic Toiletry, and Fragrance Association (CTFA) 2008: Personal Care Products Council (PCPC)


Council Mission and Goals


PCPC Self-Regulatory Initiatives

Development of worldwide uniform ingredient nomenclature and the publication of the International Cosmetic Ingredient Dictionary

Establishment of the Cosmetic Ingredient Review (CIR) Decades of research on color additives, nitrosamines, dioxane,

alternative methods to animal testing Development of industry guidelines for safety testing, micro and QA Guide legislative activity at the national and state level


EFfCI Certification - how does it work? Supplier selects a 3rd party audit organisation (ideally the one that

already provides ISO 9001 certification)

Typical ISO certification audit process – 1st stage, 2nd stage, CAPA, Certification

At least Annual surveillance audits and triennial re-certification

Costs (financially and time) for an EFfCI GMP assessment are comparable to the overall ISO 9001 certification.

EFfCI Certification


EFfCI Certification - how does it work? Audit Report lists observations and rates findings major or minor

3rd Party Technical Experts review audit report and findings, recommend certification if no major without CAPA, no minors that indicate failure of quality system element

Audit Report available to customer from ingredient supplier

Cosmetic manufacturer uses Audit reports as part of supplier qualification and uses content to judge compliance to the “appropriate” EFfCI GMP needed for their use of the ingredient

Process fully transparent, suppliers and users allowing verification of 3rd party audit organisation, certificate and auditors at all times.

EFfCI Certification


Overview of relationships

EFfCI IngredientSupplier

Ingredientuser

3rd Party Audit Organisation

Legal Agreement with3rd party auditOrganisations

Publish list and Certificates on website

Can verify certificatewith EFfCI

Agreement with supplierProvides audit report

and Certificate Verification audit service

AUTHENTICATES CERTIFICATE AND 3RD PARTY AUDIT ORGANISATION

EFfCI – how does it work?


EFfCI Certification Quality Assurance of Certification

The EFfCI website http://effci.org/ provides the following verifications…

➢ List of 3rd party audit organisations who comply with requirements and who have signed the legal agreement with EFfCI;

➢ EFfCI Certified organisations and their status.

http://effci.org/


Jointly revised with PCPC

Builds on the basic Quality Management System required in ISO 9001 and amplifies the requirements to include the GMP principles in the EFfCI Standard

Assessment to ISO 9001 and EFfCI GMP can be simultaneous

EFfCI GMPGood Manufacturing Practice 2017


The EFfCI Standard includes:

APPENDIX D – Certifications Scheme Rules

APPENDIX E - Auditor Competency and Training RequirementsA Training Guide included with specific requirements for ingredients.

EFfCI CertificationQuality of Auditors is Critical


Provides Training

Legal Agreement with3rd party trainingOrganisations

Publish list on website

EFfCI Certification Auditor Training

EFfCI 3rd Party Training Organisation

Internal AuditsSystem Design

IngredientSupplier

EFfCIAuditor

3rd Party AuditOrganisation


EFfCI Certification Quality Assurance of Auditors

APPENDIX E - The auditor requirements

Education: tertiary education in scientific discipline or > 10 years experience in relevant fields.

Work experience: a minimum of 2 years work experience in the quality unit at pharmaceutical/cosmetic/chemical/food manufacturing company;

5 years of audit experience in the above industries’ manufacturing operations to a recognized GMP standard.

Audit experience: meet requirements for Lead Auditor qualification for ISO 9001 (or other ISO high level hierarchy) or EXCiPACT registered auditor;

at least 5 audits in previous 2 years against ISO 9001 or equivalent that includes conformity to GMP principles (ISO/FSSC22000, ISO 22716, ICHQ7, EXCiPACT,)

Knowledge and understanding of the EFfCI GMP requirements, by attending an EFfCI training course or any other documented evidence related.


APPENDIX E EFfCI AUDITOR TRAINING COURSE Mandatory for Certification Auditors

Training requirements are aimed at ensuring auditors can reliably and consistently assess cosmetic ingredient suppliers for compliance with the EFfCI GMP Certification Standard.

They have been designed to illustrate the key principles of EFfCI GMP, in particular to auditors who are familiar with the chemical industry. Similarly these requirements will help auditors who are familiar with more demanding GMP industries (e.g. pharmaceuticals) relate to the less documented systems that will be in place for the manufacture of cosmetic ingredients.

EFfCI CertificationHow to become an EFfCI Auditor


MODULE 2

GMP FOR COSMETIC INGREDIENTS



What is a cosmetic? A "cosmetic product" means << any substance or preparation intended for

placing in contact with the various external parts of the human body

(epidermis, hair system, nails, lips and external genital organs) or with the

teeth and the mucous membranes of the oral cavity with a view exclusively or

principally to cleaning them, perfuming them or protecting them in order to

keep them in good condition, change their appearance or correct body

odours.>>

What is a cosmetic ingredient? Cosmetic ingredients are substances or preparations that are intentionally included in a cosmetic productThe quality of cosmetic ingredient may have a direct impact on the finished product depending of the product itself or its use.

GMP for Cosmetic Ingredients


What is GMP? What is Cosmetic Ingredient GMP? The evaluation of the risk is part of the process of Cosmetic ingredientAnd it will be the objective of the auditor: his observations related to the risk for the manufacturing of finished products

GMP for Cosmetic Ingredients

ISO 22716 requirements

EFfCIrequirements ISO 9001

requirements


The product shall not intentionally or unintentionally harm the end user.

The product specification is not a complete definition of product quality.

Product purity

Consistency of product quality from batch to batch, through use of the same◼ Product plant/manufacturing process, ◼ Raw materials, ◼ Batch Analysis, ◼ Recipe, ◼ Controls over reprocessing and reworking, ◼ Controls over reused ingredients (e.g. solvents, recrystalisation).

EFfCI GMP Principles


Change Management System Traceability of actions (records) Traceability of raw materials to finished products related to production

process (here cosmetic raw materials) Traceability of sold products to customers Scientific basis for making product quality decisions – Good science - a

result is more worth than thousand words Suitable evidence of cosmetic ingredient stability in the supply chain up until

the point of use by the cosmetic manufacturer (historical data, technical experience & analogues could be used – no strict ICH 7 test programs are required)

Out of Specification Procedure (OOS) Quality unit separate from production and commercial pressures Calibration of critical manufacturing and analytical equipment (same

requirement as ISO 9001)

EFfCI GMP Principles


Emphasis to controlling the quality of the cosmetic ingredient Commitment to EFfCI GMP policy, QA Manual, communication to customers Enhanced role of quality unit in regard to reviewing and approving quality

documents Requirement to define specific responsibilities, e.g. Supplier approval, Raw

material, packaging release for use, Batch release Additional requirements for documented procedures (as applicable):

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

EFfCI CertificationMain differences between Standard and ISO 9001


MODULE 3

RISK MANAGEMENT

EFfCI AUDITOR TRAINING


Relationship between Hazard and Risk

What may be a Cosmetic Ingredient Hazard?

Cosmetic Ingredient GMP Risk Assessment



What may be a Cosmetic Ingredient Hazard?Something which causes harm to the consumer

What could cause harm to the Consumer?





What could cause harm to the Consumer?Microbiological contaminationToxic impurities and substancesChanges to the ingredient which lead to a different composition





What is a Risk?





What is a Risk?The probability that the harm posed by the hazard is realised:

Risk = Probability x Hazard





What is a Risk?The probability that the harm posed by the hazard is realisedRisk = Probability x Hazard

Can the risk be reduced to Zero?



What is a Risk Assessment related to EFfCI GMP?

A systematic process of organizing

information to support a risk decision to be

made within a risk management process.

It consists of the identification of hazards

and the analysis and evaluation of risks

associated with exposure to those

hazards.


EFfCI GMP Risk Assessments – Key areas

Risk Identification Risk Classification Risk mitigation Ongoing Risk Review There are many Risk Management tools

available ◼ Typical for cosmetics HACCP or FMEA (use the simplest

tools – keep it simple!)◼ Always consider Process Capability


Section 0.3.3. – Process Approach, Risk Based Thinking Cosmetic ingredient manufacture is diverse and so a single set of

specific GMPs will not applicable for all materials. So the cosmetic ingredient supplier should identify the potential risks

and then take planned steps to minimise the risks. Suitable risk assessments include HACCP (Hazard Analysis and

Critical Control Point) or FMEA (Failure mode evaluation analysis), 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 (e.g. time, temperature, pressure), and necessary monitoring points.

These principles have always been built into EFfCI Cosmetic Ingredient GMPs.



Section 6.1 Actions to address risks and opportunities

EFfCI Lists the other sections requiring or using risk assessments

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



Example of a Risk Assessment Clause7.1.3 InfrastructureThe 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 a 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 operation (internal or external)b) State of repair of the building and facilityc) Suitable size construction and locationd) Ability to maintain a suitable clean building and facility environmente) Operations that can affect the cosmetic ingredient qualityf) Presence of airborne contaminants especially highly sensitizing or

toxic substances



EFfCI GMP Audit Expectations

Auditors will expect a defined scope of risk assessment and DOCUMENTED risk assessment itself

The risk assessment could be a separate document or embedded within individual procedures

Documented justification of methods or why certain requirements are applied will be expected by auditors (no alternative check or judgement are expected)

The risk assessment does not have to be extensive but should provide adequate rationale for auditors to make a reasonable assessment of adequacy of EFfCI GMP compliance.


Water Quality Potable water (city water, tap water)?

Residual Solvent Present as solvent By-product Raw material component

Contamination Prevention Process Utilities Worker Attire

◼ Outer garments◼ Jewelry◼ Hair covering where adequate e.g. very sensitive products◼ Gloves

Processing Environment (definition ? adequate examples or pictures)◼ Outdoors◼ Indoor enclosures.

EFfCI GMP Risk Assessments – What might go wrong? Considerations?


Contamination Prevention Packaging

◼ Bulk◼ Discrete Packages

◼ Open head Drum◼ Tight head Drum◼ Bags◼ Box.

EFfCI GMP Risk Assessments – Key areas (cont.)


Auditors are good at identifying hazards

Good auditors need to determine the Risk before drawing conclusions

In determining the risk auditors should:- ask if the hazard has been identified- ask if the risk assessment includes the hazard- review the risk assessment- review deviations, complaints and non-conformities to see if

the hazard has been realised



MODULE 4

WHEN DOES GMP START?

EFfCI AUDITOR TRAINING


Chemical Manufacturing sequence On receipt of the raw materials?

At the point at which the major parts of the cosmetic

ingredient are synthesized?

At the first chemical reaction where the ingredient is

designated as a cosmetic grade ingredient?

At the final purification step?

When does GMP startFor ingredients


Manufacturing sequence


Raw Materials Step 2Step 1 Cosmetic ingredient




Raw Materials Step 2Step 1 Other Product

Step 3 Cosmetic Ingredient

A small part of material goes to Cosmetic Ingredient




Raw Materials Step 2Step 1 Cosmetic Ingredient

Step 3 Other Product

A small part of material goes to other products


Manufacturing sequence On receipt of the raw materials? At the point at which the major parts of the cosmetic

ingredient are synthesized? At the first chemical reaction where the ingredient is

designated as a cosmetic grade ingredient? At the final purification step?

Much depends on the sequence of activities The GMP should start at the earliest point in the

manufacturing process in which exclusive control can be applied

Or at the first chemical reaction where the ingredient is designated as a cosmetic grade ingredient.



EFfCI GMP Starting Steps

Chemical and Physical transformations, e.g. Salt formation Dehydration Polymerization

Purification, e.g. Crystallization Distillation Filtration Heat Treatment

◼ Calcination◼ Furnace.


Process Flow Charts

Always ask for a process flow chart

Where does EFfCI GMP start in the process? Where does the supplier say it starts Do you agree?


Cellulose Derivative

Applications in Industrial, Cosmetics and Food Thickener

All grades produced on same equipment.

Where would the GMP start in this case?


Cellulose Derivative

Applications in Industrial, Cosmetics and Food Thickener

All grades produced on same equipment.

Where would the GMP start in this case?

The starting point for GMP would not be dependent on the equipment, but the manufacturing process


Where does EFfCI GMP start?Typical Excipient flow chart: Glycerin

loadingofbulk

storage

bleaching

shipping

distillation

drying

evaporation

decantation

storageofmaterial


The GMP should start

at the earliest point in the manufacturing process in which exclusive control can be applied

or

at the first chemical reaction where the ingredient is designated as a cosmetic grade ingredient.


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