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ISO 22716: Cosmetics - Good Manufacturing Practices (GMP)

Reference standard

ISO 22716 is an international standard that defines the requirements for the best manufacturing practices for cosmetics.
This standard addresses to all the organizations that have as scope of activity production, control, storage and expedition of cosmetics.   
The standard promotes an integrated approach of the processes in order to efficiently provide products that comply with the quality requirements of the product and with the clients’ requirements.   
The standard has requirements for:

 

GMP Component Compliance requirement
Personnel Should be trained.
To be allocated sufficient human resources for the performance of the activities.
Hygiene rules to be respected.
To have access to and to comply with the relevant documents for its responsibilities. To be in a good health condition. 
Premises To be designed, built and used so that:   
  • To ensure product’s safety;
  • To allow cleaning, sanitisation and maintenance of the spaces;
  • To minimize the risk of finite products, raw materials and packages contamination;
  • To be properly lightened and ventilated.

Equipment To be designed so that product contamination is prevented.   
To be made of a material that is compatible with the product, the cleaning and sanitization agents.
To present no risk for the personnel.
To be calibrated, clean. 
Raw materials and packaging To comply with the acceptance criteria relevant for the quality of the finite product.   
To be accompanied by the analysis certificates.
To be properly stored.   
Production There should be relevant documents for every stage of the production operations.   
The formula of the product shall be respected.
There should be an interphases control of the production process, based on a defined plan.
Finite product To fulfil the acceptance criteria.
Storage, transportation and retour shall be done so that the integrity and quality of the finite product shall not be affected.   
To be controlled based on pre-established methods and acceptance criteria.
Quality control The criteria established under sections „personnel”, „premises”, „equipment”, „outsourcing” and „documentation” are applicable to this section. 
There should be defined testing methods, adequate and available through which the acceptance criteria of the finite product shall be complied.
Waste Waste shall be disposed in compliance with applicable legal regulations.
Outsourcing There should be written contracts for outsourced activities.
Claims and product recall There should be a claims centralization system, if the situation. 
There should be an action plan for the recall of non-conform product.
Internal Audit There should be personnel responsible with the internal audit, including the taking of the corrective measures.  
Documentation There should be established, designed, installed and maintained a system of documentation. 
Documentation shall be permanently revised and updated and archived.

 

Advantages of ISO 22716 certification

  • Compliance of the production, control, storage and shipment processes to the international requirements for cosmetics ;
  • Creating the competitive advantage through the promotion of the cosmetics safe for use ;
  • Creating a progressive organizational culture through the responsibility needed at all levels;
  • Enhanced reputation.
 

Why SRAC

SRAC has initiated the system certification in compliance with ISO 22716:2007 (SR EN ISO 22716:2008): Cosmetics – good manufacturing practices (GMP).
Upon the certification process successfully completed, SRAC certified organizations:

  • have the right to use SRAC and IQNet conformity marks for advertising purposes;
  • are regularly informed on the evolutions in certification area, by accessing SRAC website, events organized by SRAC.
 

Why certification

For an organization to efficiently perform its activity, this should identify and manage more correlated activities.
Every successful organization should:

  • To identify all the risks of  its activities, including the risk regarding the safety in using the produced cosmetics;
  • To use a logical and objective methodology in order to classify these risks according to their importance;
  • To direct its good manufacturing practices so that it can follow the improvement and minimization of this kind of risks.

The implementation and certification of a system regarding the good manufacturing practices for cosmetics means the choosing of a systematic approach for the identification of the potential risks related to products safety and finding the actions needed for the elimination or reduction of such risks. The implemented system regarding good manufacturing practices represents a useful „tool” that allows organizations of any size or type to control the impact of activities, products, services upon the safety of the cosmetics it produces.



INQUIRY FORM
  • ISO 9001 are in vedere orientarea catre client si evaluarea satisfactiei acestuia precum si angajamentul top managementului pentru o imbunatatire continua.
  • ISO 14001 solicita unei organizatii sa declare ceea ce face in privinta controlarii si reducerii impactului sau asupra mediului inconjurator.
  • OHSAS 18001 reprezinta un model de lucru pentru organizatiile care doresc un control mai bun asupra riscurilor profesionale.
  • Standardul are la baza confidentialitatea, integritatea si disponibilitatea informatiei.
  • SR EN ISO 50001 specifica cerintele pentru stabilirea, implementarea, mentinerea si imbunatatirea unui sistem de management al energiei.
  • Este standardul cel mai acceptat international pentru producatorii de aparatura medicala.
  • ISO/IEC 20000 este primul standard international care defineste cerintele unui sistem de management al serviciului
  • ISO 37001 - standard pentru stabilirea, implementarea, mentinerea si imbunatatirea unui sistem de management anti-mita, proiectat pentru a impune o cultura anti-mita intr-o organizatie si pentru a implementa controalele adecvate.
     
  • Standardul asigura siguranta alimentelor de-a lungul filierei agroalimentare pana la punctul final de consum.
  • ISO 22000-C: certificare sistem de management integrat ISO 22000+ISO 9001
  • FSSC 22000 Produse alimentare este destinat producatorilor de produse alimentare cuprinde ISO 22000, ISO/TS 22002-1 si extracriterii adaugate de Fundatie.
  • FSSC 22000 Ambalaje alimentare este destinat producatorilor de ambalaje destinate filierei agro-alimentare si cuprinde ISO 22000 + ISO/TS 22002-4
  • Certificare pentru lanturile de productie si distributie alimentara: IFS, BRC, GLOBALG.A.P., etc.
  • Pentru a putea vinde sub eticheta de produce ecologice/bio/organice este nevoie de certificare ECO. Agricultura ecologica reprezinta un sistem de gestiune agricola si productie alimentara.
  • SA8000 se bazeaza pe principiile normelor internationale de munca.
  • ISO 22301 este primul standard international pentru Business Continuity Management.
  • Sedex SMETA (Sedex Members Ethical Trade Audit)
  • ISO 22716 - Cosmetice. Bune practici de fabricatie (BPF), standard ce se adreseaza tuturor organizatiilor care au in domeniul de activitate productie, control, depozitare si expediere produse cosmetice
  • SR EN 15224 - Servicii de ingrijire a sanatatii: standardul include cerinte concrete referioare la siguranta pacientului si managementul riscurilor clinice in procesele de planificare, realizare si gestionare.
  • Certificarea BS 7499:2013 a sistemului de management al serviciilor de paza si protectie
  • EMAS este instrumentul european de management de mediu si audit.
  • Reg. (UE) nr. 333/2011 este destinat organizatiilor care au ca domeniu de activitate colectarea, reciclarea si tratarea deseurilor metalice.
  • Reg. (UE) nr. 715/2013 de stabilire a criteriilor de determinare a conditiilor in care deseurile de cupru nu mai constituie deseuri.
  • Reg. (UE) nr. 1179/2012 determina conditiile in care cioburile de sticla inceteaza sa mai fie deseuri.
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