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					                                                                                                      E V E N T RE PORT
                                                                                G M P I N CO S M ET I C S




GMP in Cosmetics
National and International Aspects
SWISS SCC Training Event, September 24, 2004, Olten, Switzerland




                                                                                              as the GMP certificate certifies the pro-
                                   Introduction                                               duction facility in Switzerland. Certain
                                                                                              countries require additional certificates
                                                                                              and an additional legalisation from the
          ho believed, that GMP – the Good Manufacturing Practice – in cos-

 W
                                                                                              BAG. The additional BSE certificate is
          metics is a dry topic and relevant only for technicians, had to                     specific to the material (i.e. type A: BSE
          change her/his mind at the training event of the SWISS SCC in                       free, type B: without high risk material...)
 Olten, Switzerland. GMP showed itself from its brilliant and most fascinat-                  and will only be issued exceptionally – as
 ing side. The training event of the SWISS SCC takes place every year with                    for China – from the BAG. In his sum-
                                                                                              mary Dr. Michel Donat would appreciate
 changing topics and about 20 – 25 participiants join. The final number of
                                                                                              a for CH specific tailor made GMP guide-
 about 50 participants was a surprise for all, who had underestimated the                     line for cosmetics as reference, which
 interest/actuality of this topic.                                                            should clearly differentiate from the
 In the morning, moderated by Dr. Hans-Jürg Furrer, excellent speakers                        HACCP (food) und currentGMP (pharma-
 highlighted in various presentations »GMP in cosmetics« from a national                      ceuticals). Starting with incoming raw
 and an international point of view. The afternoon was dedicated to a work-                   materials up to the finished product in
                                                                                              export, all parameters of product quali-
 shop to give the the participiants also a chance to obtain practical experi-
                                                                                              ty should be recorded from human, tech-
 ence.                                                                                        nical und administrative point of view.
                                                                                              Since 1994 guidelines for GMP cosmet-
                                                                                              ics exist from the COLIPA (European
                                                                                              Union of the National Industrial Associ-
                                                                                              ations) and from the Council of Council.
                                                                                              In 2002 a ISO working group had been
 National - Switzerland                      control. Therefore also cosmetics have to       reactived ref. GMP in order to develop
                                              follow the Good Manufacturing Practice          standards, and Switzerland has the same
Dr. Michel Donat from the Health Minis-       and even a legal audit does not release         right and importance in voting as i.e.
tery of Switzerland (BAG) concentrated        from the duty of self control. Refering         USA. At present a »draft international
on Swiss aspects of GMP in cosmeticts.        export of cosmetics from Switerzland,           standard« is in circulation. In 2003 the
Historically GMP in CH already exists for     depending on the category of the cos-           DG Enterprise (European level, Brüssel)
a long time for pharmceuticals - where-       metics and the requirement of the im-           worried the industry as they published
as cosmetics do not have a legel GMP          porting country, more complicated or            the draft of a more restrictive guideline.
regulation /guideline. Even if cosmetics      a more simple registration procedures           It is foreseen that the ISO in its final
are regulated within the food regulation      exist. Partially certificates are only issued   stage will be accepted as standard. For
(incl. tabacco and alcohol), the approach/    by the Cantonal Chemist, partially signed       Switzerland a not legally binding »soft
guideline of HACCP (Hazard Aalysis and        by the BAG also. The export goods are ac-       law« could become. For the time being
Critical Control Point) in the food sector    companied by certain export certificates.       there are a lot of negotiations, which of
is not valid for cosmetics. In chapter 3 of   The Free Sales certificate (FSC) confirms       the variations (ISO or European Commis-
the food regulation 817.0 however there       the legal acceptance of traffic of a com-       sion) will become valid in the EU. Dr.
is a clear advise for the principle of self   pany/ref. products in Switzerland, where-       Michel Donat it seems to be more fraught


SÖFW-Journal | 130 | 12-2004                                                                                                           79
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with meaning to adapt the ISO variation
in CH, but if any possible is has to be
avoided to create an exceptional case for
Switzerland.


 International - EG/Germany

In the second presention, Germany and
Europe had the attention of the audito-
rium, presented by Hans-Peter Gesell of
the HPG Consulting, Germany. Since the
enforcement of the 6 th Amendment in
1997, clear requirements on European
level exist for GMP cosmetics, but till
now legally there are no clear imple-
menting statutes. In article 7a, point c of
                                               Fig. 1 (f.l.t.r.): Chairman: Dr. Hans-Jürg Furrer, Speakers: Pierre Bottiglieri,
the 6th Amendment the Good Manufac-
                                               Dr. Marion Fröschle, Walter Scheffel, Hans-Peter Gesell, Dr. Michael Donat,
turing Practice (GMP) is required. The
                                               Dr. Hans Zulliger.
same article determines the necessary
qualification of the person, responsible
for manufacturing and the first import
action. In the national enforcement in        ally this is determined in the job de-        companies. Directions are ordered and
Germany, the 25th adaption of the cos-        scription/working description within the      time limits given at non complying is-
metic guideline the article 5c, paragraph     company organisation. According to the        sues. In the enforcement of the cosmet-
1 requires the preparation of documents       IKW redommendations only those per-           ic GMP in companies within Germany
and according to article 5b, paragraph 1,     sons are qualified to head a cosmetic pro-    exist big ranges due to missing exact im-
Point 33 also the good manufacturing          duction, who have a final technical or sci-   plementation statutes.
procedure. The law permits a big space        entific eduction and have at least 3 years    Hans-Peter Gesell believes an enactment
not differentiating between huge or           experience in a leading position in a cos-    of cosmeticGMP guidelines from the EU.
small companies and is valid for all cos-     metic or similiar production facility.        The advantage would be a common rule
metic product categories. The manufac-        From the IKW, COLIPA (European Associ-        in all EU countries. However disadvan-
turers have to obey the cosmetic-GMP          ation for Cosmetic Companies) and from        tage could be that more rigid require-
rules in all departments of manufactur-       the Council of Europe since 1994 various      ments as now would come into action
ing, assuring an adequate professional        publications exist on DIN ISO 9001, guide-    with narrow limits. A harmonisation of
qualification of the person responsible for   lines to cosmetic GMP, checklists for self    the existing cosmeticGMP guideline in
production. The manufacturing accord-         control and additional specific recom-        the different countries must be the goal.
ing GMP has to be signed in the product       mendations.                                   On the long term the cosmetic GMP could
dossier by the responsible person.            According to Hans-Peter Gesell the DIN        move much closer towards the GMP
In the manufacturing practice therefore       ISO 9001 does not replace cosmetic GMP,       guidelines in the phamaceutical indus-
cosmetic GMP directly influences the de-      as the DIN ISO 9001 does not give any or      try.
partment of production, quality assur-        only marginal support at the realization
ance and logistics and indirectly the         for the specific requirements of a cos-
board as well as adjacent departments.        metic production facility. To obey the ISO
Based on presently existing guidelines,       has no influence on the product quality,       International - USA
specific requirements exist as i.e. for       as the certification according DIN ISO
personnel, the facilities, the technical      9000ff only confirms the existence of         Under picture of a waving American flag
equipment, the plant hygiene, the raw         the required written directions.              Dr. Marion Fröschle started her presen-
materials, the manufacturing processes,       The proceeding action of the control au-      tation on GMP in USA. Based on the 1938
the quality control and the documenta-        thorities in the various countries of the     enforced Federal Food, Drug and Comet-
tion. Of course legally in the first place    EU is due to missing implementation           ics Act ( FDCA) and the 1967 enforced
the board is resonsible for the quality of    statutes still very different. Based on ex-   Fair Packaging and labelling Act (FPLA)
the manufactured products, whereby ac-        periences of the manufacturer in Ger-         the congress in USA has passed 2 basic
cording to a recommendation of the            many the control authorities of the           laws for cosmetics. In title 21 of the Code
IKW (Industry Association for Cosmetics)      countries or of the administrative dis-       of Federal Regulations (CFR) all cosmet-
the responsibility can be delegated to        tricts perform their audits, not differen-    ic products are regulated. In 1960 the
the person for the manufacturing. Usu-        tiating between huge, medium or small         Amendment of Color Additives was is-


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sued, 1972 the OTC Drug Listing ACT. In          drugs are not restricted to specialized      departments of R&D, marketing (decla-
Europe legally there are 2 clearly differ-       drug stores and may be sold in any type      ration, labeling) and export. The process-
entiated categories: cosmetics (regulat-         of retail establishment.                     validation i.e. of computerized and/or
ed under food law) and pharmaceuticals/          The office of Food and Drug Administra-      automatic process seem to be of special
drugs (pharmaceutical law). In USA it is         tion (FDA) is in US the responible minis-    interest in audits of the FDA, at which
similar: there is the category of cosmet-        tery with the department CFSAN = Cen-        even the need of a revalidation has to be
ics (also regulated within the food law)         ter für Food, Safety and Applied Nutri-      evaluated. Importing cosmetic products
and the category of drugs/pharmaceuti-           tion for cosmetics and the department        to US, no registration/notification has to
cals. The pharmaceuticals however are            CDER = Center für Drug Evaluation and        take place, only a voluntary cosmetic reg-
differentiated additionally, as within this      Research for OTC/Cosmetic-Drug prod-         istration programm exists with public in-
category next to pharmaceuticals also            ucts. As part of the department of Health    formation access. On the contrary, for OTC/
OTC (Over the Counter) products are reg-         and Human Services the FDA is a huge         cosmetic-drugs the manufacturing-/pro-
ulated - and within this sector also the         ministerial apparatus with more than         duction facility and the products (incl.
so called cosmetic-drugs. According US           9000 employees, regulating about 1/4 of      label copy of the selling version in US)
law FDCA ACT the ingredient/composi-             the American economic system, inclusive      have to be registered/notified. Costs for
tion in the formula (OTC Monograph) as           food (incl. cosmetics) und pharmaceuti-      the registration/notification are about
well as the intended use and/or the claims       cals (incl. OTC / cosmetic-drug products,    200 $/year for each OTC/cosmetic-drug
on packaging are decisive to consider a          biologics….). It is the biggest regulatory   product and 200 $/year for the produc-
product as cosmetics or as OTC/cosmet-           organ, also responsible for the assurance    tion facility. For OTC/cosmetic-drug prod-
ic-drug product. Claims that the product         of the law enforcement after the prod-       ucts, each production facility/foreign dis-
cleanses, beautifies or promotes attrac-         uct has entered the market. cGMP can         tribution company has to announce an
tiveness are i.e. – similar as in Europe- cos-   mean cosmeticGMP (for cosmetics in Eu-       agent (citizen of US) as contact partner
metic products. Claims, that the product         rope and US) as well current GMP (for        for the FDA. The registration of OTC prod-
affects the structure or the function of         pharmaceuticals in US/Europe and OTC/        ucts in the US is regulated under the pe-
the body, as i.e. activates the regeneration     cosmetic-drug products in US). In the US     nal law. The fine if not complying the
of the skin or protects the skin against sun     based on 21 CFR 210 & 211, any of the        registration procedure (OTC products
damage are clearly in US OTC/cosmetic-           CDER regulated drug product – and there-     and production facility) can vary from
drug product claims. A product may be            fore also all OTC/cosmetic-drug products     1000 $ up to 1.000.000 $.
considered solely as a drug, solely as a         - have to be produced according to cur-      The production facility (incl. i.e. packag-
cosmetic or as both, a drug and a cosmetic       rrent GMP. The current GMP ist much          ing and store….) can be audited – when
under the FDCA definitions for a »cos-           stricter then the cosmetic GMP. Trans-       required- by the FDA according current-
metic« and a »drug«. A cosmetic product          parency and back tracing of the total        GMP, taking samples for investigation.
as i.e. a care-day cream with SPF 15 has         production process has to be assured         The FDA is authorized, to confiscate non
to obey both regulations (cosmetics and          apart from additional quality systems in     conform products and to inititate penal
OTC). Even though the regulations for            all involved parts of a company. Addi-       notice. The US custom office together
OTC drugs and cosmetics are different,           tional requirements refer to complete QS     with FDA are commonly responsible for
both kind of products are treated the            processes/ documentations beside the         the import of cosmetics and OTC/cos-
same on the distribution level. In US, OTC       production and purchase sector also i.e.     metic- drug products. The FDA can deny
                                                                                              the import of OTC products, which are
                                                                                              produced, filled or packed at a non reg-
                                                                                              istered production facility. Based on pre-
                                                                                              liminary random check at the duty, the
                                                                                              products can be automatically released,
                                                                                              blocked or intensively rechecked. As af-
                                                                                              ter the 11th September 2001 an increased
                                                                                              safety issue has occured, the FDA has got
                                                                                              a huge amount of millions of $, to in-
                                                                                              vestigate and assure in a more efficient
                                                                                              way safety issues– especially of import-
                                                                                              ed goods . The OTC Labeling Monograph
                                                                                              is published and already valid for longer
                                                                                              time, the Sun Monograph is as well pub-
                                                                                              lished, planed to be enforced in 2005 and
                                                                                              already in major parts followed by the
                                                                                              industry. Till now inspections have not
 Fig. 2 Attentive Auditorium                                                                  been very probable, but now, based on
                                                                                              the big amount of money released from


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                                                                E V E N T RE PORT
                                                G M P I N CO S M ET I C S



the congress for the FDA, they become
more realistic. Based on the OTC Label-
ing and Sun Monograph specifially an
                                               We cover the world
increased investigation of imported
products with sunfilter (SPF claims) can
be anticipated.
Nevertheless, the issue of an import bar-
rier – depending on the economic situa-
tion of the ref. country - should also be
kept in mind when looking at increased
regulatory requirements ref. trade rela-
tions between countries.


 International - Asia

Pierre Bottiglieri of PAP Cosmetic Sci-
ences S.A. entered into details of the
GMP situation of the far east countries.
ASEAN, the Association of the southeast
nations was established 1967. Members
are Brunei Darussalam, Cambodia, In-
donesia, Laos, Malaysia, Myanmar (ex-
Burma), Philippinen, Singapore, Thailand
und Vietnam. Since 1997 ASEAN is on
the way to become one single market
with about 500 Mio consumers. ASEAN
Guidelines to cosmetic GMP are published
and refer to – similiar to EG – i.e. to per-
sonnel, equipment, hygiene, production,
the quality control and the documenta-
tion. In China und Honkong however no
GMP standard exists. All production fa-
cilities have to apply for a licence, called
»productions-license«, which is valid for
5 years. The licence is issued for the fac-
                                                                            Media
tory (not for the products) and is super-
vised and monitored by the cosmetic De-
partment of China Light Industry Feder-
ation. Special licences have to be applied
                                                                             2005
ref. OTC products. In India Guidelines for
cosmetics are observed by FDA India with
reference to the Drugs and Cosmetics              Verlag für chemische Industrie
Act (1940) and Rules (1945), both con-
tinously amended when required by                          H. Ziolkowsky GmbH
Government notifications. The »manu-                            Postfach 10 25 65
facturer-licence« ist valid 2 years. The
Japan Industry Association (JCIA) pub-                           86015 Augsburg
lished in 1980 a self regulation on GMP,                 Tel: +49 821 325 83-16
which is currently under process of re-
viewing in order to change the content                    Fax: +49 821 325 83-23
drastically. The structure of the new                e-mail: s.fischer@sofw.com
regulation will be more systematic and
it will contain general rules as well as                          www.sofw.com
clear instructions ref. manufacturer/
quality control. It is expected that the
corresponding revised draft should be


SÖFW-Journal | 130 | 12-2004                                                        83
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                                                                                            dations for measures of a reconstruction
                                                                                            respectively a sanitation especially deal
                                                                                            with the right property of ceiling, walls
                                                                                            and flooring for an easy but effective
                                                                                            desinfection.


                                                                                             Workshop GMP in Practice

                                                                                            The theoretical knowledge was put to
                                                                                            the test and approved in the following
                                                                                            workshop. Guided by 3 case studies, the
                                                                                            participants had to take different roles
                                                                                            and as fictitious quality responsibles had
                                                                                            to take decisions under the direction of
                                                                                            the SNV (Swiss Norms Association) Dr.
                                                                                            Hans Zulliger and Walter Scheffel, both
                                                                                            Cilag AG: based on various informations
                                                                                            and test data, a raw material or i.e. a
 Fig. 3 Intensive concentration of the participants required at the workshop
                                                                                            product had to be released or to be-
                                                                                            blocked. Intensive discussions and eval-
                                                                                            uations took place in the various work-
available till end 2004. In South-Korea      but also by the departments of purchase,       ing groups and the final decision with
cosmeticGMP is the so called »Enforce-       research and development, the finance,         reasons why was presented and ex-
ment Regulation«. The quality control        marketing, quality assurance, further          plained in front of the total group. De-
process is highlighed to guarantee ex-       technical departments and the board.           tailed knowledge and the comprehen-
cellent quality. In Taiwan there is no       All employees of the company are re-           sion of HPLC measuring values and vali-
GMP standard. Cosmetic factories have        sponsible for the product quality. Speci-      dation of colums were of relevance as
to meet the standard of some specific        fications are an important pre-condition       well as the exact investigation and com-
pharmceutical regulation in order to ap-     for the product quality. They should be -      pliance of methods, the regulations of
ply for a licence which is a »Certificate    if any possible - complete with reliable       valid signatures and existing – or miss-
of cosmetics manufacturing«. The cer-        tolerances and be performed using valid        ing – training qualifications of the fic-
tificate is product-specific and is issued   and same methods. The production fa-           tive employees. At the final end all 3 case
by the Department of Health.                 cility and the quality assurance have the      studies have been solved, prepared and
The Asian market is of special interest      same right to vote, a coordination be-         presented in an excellent way by the dif-
based on the huge amount of consumers        tween customer and supplier is neces-          ferent groups. The participants could –
of almost 3 billions of people (ASEAN        sary. The purchase sector has a key role:      besides a lot of intensive personal con-
500 millions, China 1.3 billions, India 1    It is responsible for costs, the quality and   tacts - take back to work an increased
billion, Japan 130 millions, Süd Korea 50    the delivery time and therefore has enor-      national and international knowledge of
millions, Taiwan 20 millions) - this means   mous influence on the product quality.         cGMP and already practical experience,
almost half of the total world population    Additionally purchase has to assure, that      gained during this fascinating training
(6.4 billions).                              all product specifications as well as the      course.
                                             delivery conditions of the factory are
                                             followed. At least 1x/year a self control                           Dr. Marion Fröschle
 Cosmetic GMP in Practice                   of the factory should take place in an in-
                                             ternal audit from quality assurance or                                                  
The afternoon was opend by Hans-Peter        from an external consultant with an ad-
Gesell with the topic »Cosmetic GMP in       equate action-plan, eliminating the weak
practice«. The product quality is not on-    points and controlling the state of the
ly influenced by the production faclity,     performed measurements. Recommen-




84                                                                                                          SÖFW-Journal | 130 | 12-2004

				
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