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.
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:
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.
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.