Quality

Audit records

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
  • PMPI*

*Polish Main Pharmaceutical Inspectorate

Inspections & Audits

Polpharma has EU GMP certificates for all production departments and all API products

  • 2020

    MPI remote inspections (Polish Main Pharmaceutical Inspectorate)

  • 2019

    MPI inspections (Polish Main Pharmaceutical Inspectorate)

  • 2018

    FDA inspections

  • 2018

    GMP API inspections by Polish Main Pharmaceutical Inspectorate

  • 2017

    MIT inspection (Ministry of Industry and Trade of the Russian Federation)

  • 2017

    MPI inspections (Polish Main Pharmaceutical Inspectorate)

  • 2016

    MPI inspection (Ministry of Industry and Trade of the Russian Federation)

  • 2015

    FDA inspection

Every year we have over 35 customer’s audit.

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)

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.

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 andCEP 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

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