Excellence audit record

Facilities for the production of APIs undergo rigorous inspections from 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, 2015 and, most recently, in May 2018. This is something we are proud of and confirms the highest quality standards of Polpharma.

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

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.

DMF documentation for all our products is prepared in accordance with the latest requirements

EDQM (CEP) ICH (ASMF in eCTD format) PMDA (J-DMF)
FDA (US DMF)

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

 
 

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


Documentation in an CTD format and
CEP certificates

Specifications for every stage
of production

Qualification and audits of suppliers

Quick response to complaints

System procedures

Compliance with cGMP

On-the-job GMP training

Validation and qualifications of equipment and production processes

 

Audits

Over 300 audits performed by our customers during years 2008-2017.

2008-2012: 1272013: 342014: 342015: 342016: 372017: 127

2003
2004
2006
2007
2009
2010
2011
2013
2014
2015
2016
2017
2018
prev

IC/S GMP Certificates

FDA Inspection

GMP API Inspections by the GMP API Inspections by the Polish Main Pharmaceutical Inspectorate

GMP API Inspections by the GMP API Inspections by the Polish Main Pharmaceutical Inspectorate

FDA Inspection

Korean Inspection

GMP API Inspections by the GMP API Inspections by the Polish Main Pharmaceutical Inspectorate

GMP API Inspections by the GMP API Inspections by the Polish Main Pharmaceutical Inspectorate

GMP API Inspections by the GMP API Inspections by the Polish Main Pharmaceutical Inspectorate

GMP API Inspections by the GMP API Inspections by the Polish Main Pharmaceutical Inspectorate

GMP API Inspections by the GMP API Inspections by the Polish Main Pharmaceutical Inspectorate

Inspections of Ministry Industry and Trade of Russian Federation

 

  • GMP API Inspections by the Polish Main Pharmaceutical Inspectorate
  • FDA inspection

 

next
 
OK