Quality & documentation
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Our company meets the strict FDA requirements and Current Good Manufacturing Practice (cGMP) guidelines. The last FDA inspection in February 2009 concluded with no Inspectional Observations Form - 483.
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 the high quality of APIs produced by POLPHARMA.
DMF documentation is prepared in accordance with the latest requirements of EDQM (CEP), ICH (EuDMF, CTD) and FDA (US DMF). We have submitted applications for a number of CEPs, six of which have already been granted. Several DMFs have already been approved by the FDA.
Documentation statistics
As we are committed to providing the highest quality products, we place particular emphasis on:
- Development of cGMP
- On-the-job GMP training
- Documentation in the CTD format and CEP Certificates
- System procedures
- Specifications for every stage of production
- Qualification of suppliers
- Audits
- Quick response to complaints
- Validation and qualifications of equipment and production processes
The quality of our product is proven by the number of successful customer audits, certificates and accreditations
Latest customer audits:
Latest audit records:
PIC/S GMP Certificates (Pharmaceutical Inspection Convention Scheme):
- all synthesis departments - August 2003
FDA inspections: 1995,1997,1999,2004,2009 (no observations on 483 form)
ISO accreditations:
ISO 14001:2004 by UKAS Environmental Management
OHSAS 18001:2007
PN-N 18001:2004