Only Positive Audit Results

    HIGHEST QUALITY STANDARDS

    Facilities for the production of APIs undergo rigorous inspections of the U.S. Food and Drug Administration (FDA). Our multipurpose plant passed FDA inspections with no observations on the Form 483 in 2004, 2009, 2012 and, most recently, in January 2015. This is a reason to be proud of and confirms the highest quality standards of Polpharma.

    We supply APIs for the pharmaceutical companies worldwide. With a competitive cost of production, superior product quality and environmentally friendly processes API Polpharma became a significant European manufacturer.

    Our team of highly educated experts assures that the quality of our products is maintained at all stages of the production process. Strict compliance with cGMP procedures, well documented SOPs, and a modern quality control laboratory ensure that APIs produced by POLPHARMA are of the highest quality.

    Our products are manufactured in accordance with the most stringent requirements of our customers and health authorities (USFDA, EMA, EDQM, SKFDA, PMDA, ANVISA, Polish Main Pharmaceutical Inspectorate). DMF documentation for all our products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (ASMF in eCTD format), PMDA (J-DMF) and FDA (US DMF).

    As part of our commitment to provide the highest quality products, we put the greatest emphasis on:

    • Compliance with cGMP
    • Validation and qualifications of equipment and production processes
    • On-the-job GMP training
    • System procedures
    • Specifications for every stage of production
    • Documentation in an CTD format and CEP certificates
    • Qualification and audits of suppliers
    • Quick response to complaints

    Audits

    Over 200 audits performed by our customers during years 2008-2015
    2008 - 2012: 127    |    2013: 34    |    2014: 34    |    2015: 34

    2015  GMP API Inspections by the Polish Main Pharmaceutical Inspectorate
     FDA inspection (with no observations on the Form 483)
    2014  GMP API Inspections by the Polish Main Pharmaceutical Inspectorate
    2013  GMP API Inspections by the Polish Main Pharmaceutical Inspectorate
    2012  GMP API Inspections by the Polish Main Pharmaceutical Inspectorate
     FDA inspection
     Korean FDA inspection
    2011  GMP API Inspections by the Polish Main Pharmaceutical Inspectorate
    2010  GMP API Inspections by the Polish Main Pharmaceutical Inspectorate
     Korean FDA inspection
    2009  FDA inspection
    2007  GMP API Inspections by the Polish Main Pharmaceutical Inspectorate
    2006  GMP API Inspections by the Polish Main Pharmaceutical Inspectorate
    2004  FDA inspection
    2003  [ August ] IC/S GMP Certificates (Pharmaceutical Inspection Convention Scheme): all synthesis departments