Good Manufacturing Practice


RESEARCH LABORATORY FOR MEDICINE AND VETERINARY PRODUCTS
IN THE GMP QUALITY SYSTEM



Head: Joanna Piasecka-Zelga, PhD
phone: 48 42 631 46 53                                     
fax: 48 42 631 46 24

e-mail: Joanna.Zelga@imp.lodz.pl

 

The laboratory has  CERTIFICATE OF GMP and MAIN PHARMACEUTICAL INSPECTORATE's AUTHORIZATION issued under the Inspection carried out in accordance with Article 111 (5) of the Directive 2001/83/EC as amended by the Competent Authority, the Main Pharmaceutical Inspectorate.


Research and service activity:

The studies of medicinal products and raw materials used for their production, of veterinary products and medical devices in the Good Manufacturing Practice (GMP) Quality System:
− pyrogen test,
− systemic toxicity,
− hemolysis,
− skin irritation,
− skin sensitization,
− intracutaneous reactivity,
− sterility of medical devices,
− microbiological purity of medical devices,
− chemical testing of medical devices,
− particle pollution of medical devices.

The study of medicinal products and medical devices are performed with the consent of the Local Ethical Committee No. 9 in Lodz.

Science and development:

As part of scientific development, the Laboratory carries out projects aiming at introducing to the Polish, as well as international market, modern medical materials. The most important aspect of the research performed within the projects and grants is assessment of biocompatibility, long term stability, as well as lack of toxicity and hemolytic effect.

Research carried out as part of:
POIG.01.03.01-00-006/08-00 A KEY PROJECT,
TOPIC II PROJECT 9 KEY TASKS CARRIED OUT IN THE FRAMEWORK OF THE OPERATIONAL PROGRAMME INNOVATIVE ECONOMY 2007–2013, PRIORITY 1 RESEARCH AND DEVELOPMENT OF NEW TECHNOLOGIES, "NEW GENERATION BARRIER MATERIALS OF HUMAN PROTECTION AGAINST HARMFUL ENVIRONMENT EFFECTS", CO-FINANCED BY THE EUROPEAN UNION UNDER THE EUROPEAN REGIONAL DEVELOPMENT FUND.

RESEARCH AND DEVELOPMENT PROJECT No. 05-0026-10/2010; "DEVELOPMENT OF TECHNOLOGY FOR EFFLUENT-FREE AND LOW TEMPERATURE BLEACHING WITH SIMULTANEOUS DISINFECTION OF CELLULOSE FIBRE". COOPERATION OF THE LABORATORY WITH THE TEXTILE RESEARCH INSTITUTE.

CONSORTIUM POŁMEDIMP FINANCED BY NCBIR UNDER INNOTECH, THE PATH IN-TECH 2012–2015, TITLE:
"NEW BIOCOMPATIBLE SI-DLC LAYER FOR BONE IMPLANTS" PART 7 "CERTIFIED PERFORMANCE OF BIOLOGICAL RESEARCH" IN CONTRACT No. INNOTECH-K1/IN1/18/156542/NCBR/12.

RESEARCH PROJECT CONDUCTED IN COOPERATION WITH THE CENTER OF OCCUPATIONAL ALLERGY AND ENVIRONMENTAL HEALTH OF INSTITUTE OF OCCUPATIONAL MEDICINE "EVALUATION OF SELECTED PARAMETERS OF ALLERGIC INFLAMMATION IN THE AIRWAYS INDUCED BY LOW MOLECULAR WEIGHT ALLERGENS"


Training activity:

The laboratory is a place of training for:
− biotechnology students from Technical and Medical Universities, biotechnology, microbiology and biology departments
− Interns
   - Internships organized by the Lodz City Hall under Sub-measure 6.1.3. Human Capital Operational Programme
− Experimenters
   - Granting a license to perform studies on laboratory animals in accordance with the Act
on Protection of Animals, the recommendations of the International Council for Laboratory Animal Science − ICLAS and the Directive of the European Parliament and the Council 2010/63/EU of 22nd of September 2010 on the protection of animals used for scientific purposes.

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