Quality

The main drivers behind our business philosophy and quality policy are to meet the highest product quality standards in the market and deliver the necessary quality assurance and documentation to support our customers in the best possible way. We are proud to demonstrate an extraordinary openness about our manufacturing processes and meet you with agile decision processes.

Our quality system is in compliance with ICH’s Guidelines Q7, which enables us to manufacture products according to current Good Manufacturing Practices (cGMP) regulations and ISO 9001.

Dextran products from pK Chemicals A/S

Quality control management system

Managing and meeting quality expectations are an essential part of the quality assurance of our production. We have an up-to-date quality system and the quality assurance of our production is conducted in alignment with:

  • Requirements described in Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Part II (ICH´s guidelines Q7) and The Rules Governing Medicinal Products in The European Union Vol. 4 with applicable annexes
  • ISO 9001
  • Requirements described in 21 CFR 820 section for Quality System Regulation Oct. 7, 1996 for Medical Devices

Our Quality Management System (QMS) is governed by Standard Operation Procedures (SOP) describing in details how the work within the QMS system, manufacture and QC is conducted. Each specific operation is covered by SOPs describing in detail how operations must be performed.

We are working in close collaboration with our customers to ensure the support needed for their regulatory submissions is performed in the best possible way and audits are an integrated part of that process. The team in pK Chemicals is experienced in performing and hosting both customer audits and regulatory inspections from different regulatory bodies as applicable.

Certificates & Approvals

pK Chemicals has previously been inspected and approved by regulatory bodies (FDA and DMA). These approvals expired by the end of 2013 and were not attempted to be renewed. Going forward, inspections by regulatory bodies (DMA, FDA, etc.) will be planned and performed when applicable.

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