Quality

Quality 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

The Danish Medicines Agency has issued a GMP certificate for Malathion. Our certificate number is DK API-H 00091117.
 
Please download the GMP certificate from the EudraGMDP database operated by the European Medicines Agency: EudraGMDP.

We are also able to provide aCertificate of Suitability to the monographs of the European Pharmacopoeia (CEP) for Malathion. For more information please visit EDQM's website: Malathion EP, Monograph Details

Going forward, inspections by regulatory bodies (The Danish Medicines Agency, FDA, etc.) will be planned and performed when applicable.