Historiy

HISTORY

1987 – BIO-CHIC Sp. z o.o., a private advisory and services company operating on a dynamically developing cosmetic market is launched.

Our mission is to provide specialist services facilitating the development and operation of cosmetic companies.

Business range: development of new cosmetic technologies ready for implementation; performance of quality tests; review and inspection of import product documentation; performance of the NIH marketing approval procedure.

2001 – modification of the Company’s mission and strategy related with capital changes.

Our business focuses on the pharmaceutical and cosmetic market. A microbiological laboratory is established, specialising in the monitoring of manufacturing environment in pharmaceutical and other facilities with increased hygiene-related requirements. The laboratory performs control of microbiological purity of pharmaceutical and cosmetic products.

Our mission is specialist outsourcing for small and medium companies from the cosmetic and pharmaceutical industry to allow them to adjust their products or services to the EU requirements.

2002 – introduction of the Quality Management System – First certification of ISO 9001:2000; Scope of certification: “Microbiological testing, technical analysis and design advisory for the cosmetic and pharmaceutical industries and functional foods” (BVQI Certificate)

2003 – obtaining an EU subsidy as part of PHARE, for investment purchases for the Laboratory to perform testing according to the highest standards

2006 – BIO-CHIC Microbiological Laboratory is accredited by the Polish Accreditation Centre (PCA, No. AB 745) as compliant with PN-EN ISO/IEC 17025:2005 “General requirements for the competence of testing and calibration laboratories” with respect to:
- environments in pharmaceutical and cosmetic manufacturers and service providers of increased hygiene-related standards such as: SPA salons, hairdressing salons and beauty parlours.
- according to PB-06 testing procedure, Issue 3 of 20 March 2006.
- non-sterile pharmaceutical preparations according to the Polish Pharmacopoeia VI 2002 and PB-01, Issue 4 of 27 February 2006, excluding item 4.7.2.

2005 – BVQI Recertification Audit concerning the compliance of the BIO-CHIC Quality Management System with ISO 9001:2000 completed with recertification

2008 – extending the PCA accreditation with “Pharmaceutical preparations and non-sterile raw materials: microbiological purity of preparation according to the method of immediate inoculation in line with the Polish Pharmacopoeia VII, Vol. I-2006, Polish Pharmacopoeia 5.0 Vol. I -2005, PB-10, Issue 3 of 19 July 2007”

2009 – extending the PCA accreditation with Pharmaceutical preparations and non-sterile raw materials: microbiological purity of preparations with immediate inoculation method in line with harmonised methods – PB 13, Issue 3 of 6 March 2009

An inspection performed in November of 2009 proved that BIO-CHIC fulfilled the requirements of the Good Manufacturing Practice. We have been holding a GMP certificate since 25 November 2009.

November 2009 – BVQI Recertification Audit concerning the compliance of the BIO-CHIC Quality Management System with ISO 9001:2008 completed with recertification. Scope of certification: Microbiological testing, technical analysis and advisory for the cosmetic and pharmaceutical industries and functional foods (BVQI Certificate)

May 2010 – a PCA recertification audit, the scope updated with new reference documents: Supplement 2009 to FP VIII, Supplement 6.7 to Ph. Eur 5.0

November 2010 – transfer audit from BVQI to DNV for the compliance of the Bio-Chic Quality Management System with ISO 9001:2008 – a new certificate obtained

July 2011 – audit under the PCA supervision, the scope of accreditation updated with Ph. Eur 7.0 and Supplement 2010 to FP VIII

May 2012 - audit under the PCA supervision, the scope updated with FP IX, Vol. I 2011 and the accreditation scope extended with testing of cosmetics and cosmetic raw materials according to PN-EN ISO

September 2012 – positive result of a periodical audit of the Quality Management System by DNV

January 2013 – based on a positive result of an inspection by the Main Pharmaceutical Inspector (GIF) in November 2012 we received another GMP certificate regarding microbiological tests of non-sterile medicinal products intended for human use and the first GMP certificate for microbiological tests of non-sterile investigational medicinal products intended for human use

April 2013 – obtaining an approval of GIF for manufacturing of group II narcotic drugs and IV-P psychotropic substances for the purpose of testing microbiological purity

May 2013 - audit under the PCA supervision with a positive result, updating and extension of the accreditation with environmental testing in facilities of increased hygiene-related standards (e.g. SPA salons, beauty parlours, healthcare clinics)

September 2013 – another periodical audit of the Quality Management System by DNV – ISO certificate renewed

December 2013 - obtaining the next GMP certificate issued by the Chief Pharmaceutical Inspector (GIF) for the next three years, on the basis of the planned inspection visit in November 2013

March 2014 – audit under the PCA supervision and updating the scope of accreditation – obtaining another certificate valid until 23.07.2018.

September 2014 - re-certification audit conducted by DNV for compliance with the Quality Management System ISO 9001: 2008 and obtaining another certificate valid until 16.11.2017 r.

May-June 2015 - audit conducted by the PCA in the form of document review to maintain accreditation, updating the scope of accreditation.

August 2015 - an audit of Quality Management System for compliance with ISO 9001: 2008 - certificate maintenance.

November 2015 - the inspection by the Chief Pharmaceutical Inspector (GIF), which confirmed that the competences and activities of BIO-CHIC laboratory are in accordance with GMP, obtained another GMP certificate valid until 30 November 2018.

May 2016 - audit under the PCA supervision to maintain accreditation and updating the scope of accreditation.