Quality Policy
At KD Pharma Group, our commitment is to:
- never compromise on the Quality, Safety and Compliance of our products
- ensure that all applicable regulations, sound scientific principles and customer expectations are implemented on the design, development and delivery of our high quality pharmaceutical, food, feed and dietary supplement products
At KD Pharma Group, CMC (Chemistry, Manufacturing and Controls) applies to all stages of pharmaceutical development and focuses on creating consistency in drug product stability, release, and manufacturing. KD Pharma Group products comply with all guidance before they are declared safe and released into the market.
Quality Management System
Our QMS is fully integrated into the systems supporting the development, manufacture and analysis of our products throughout their entire lifecycle.
Our approach is on a risk-based thinking meaning that factors which could potentially cause deviations from set standards are considered carefully and preventive controls are implemented to eliminate or minimize the occurrence of adverse influences.
Quality Control
Our global team with more of 50 specialized scientists and technicians, we are able to deploy a comprehensive range of state-of-the-art analytical techniques in order to support our stringent quality and safety standards.
Regulatory Affairs
KD Pharma produces according to the requirements of official compendia such as:
- US Pharmacopoeia
- European Pharmacopoeia
- Japanese Pharmacopoeia
- World Health Organization (WHO)
- Global Organization for EPA & DHA Omega-3 like GOED and AOAC
Our team is able to support with the following expertise in:
- DMF and ASMF preparation and filing.
- CEP applications
- ANDA application
- Novel Food application
- GRAS applications
Our Certifications: not only a commitment, but a true value
The quality of KD Pharma Group's products is reflected in the numerous certifications and successful inspections achieved by the company over the last 30 years. Some of the certifications at KD Pharma Group sites are:
- ISO 9001:2008
- ISO 14001:2009
- ISO 50001:2011
- HALAL
- FOS (Friend of the Sea)
- GMP approved for Active Pharmaceutical Ingredients (API)
- FDA approved for Active Pharmaceutical Ingredients (API)
- Korean MFDS (formerly known as KFDA) approved
- FDA food facility registered
- HACCP from UK Food Safety Agency
- Friends of the Sea (FOS)
- FEMAS standard for all feed ingredients
- GMP facility registered
- FDA food facility registered
- GMP approved for Active Pharmaceutical Ingredients (API)
- HACCP from Norwegian Food Safety Authority
- Friends of the Sea (FOS) Certification
- Marine Stewardship Council (MSC) Certification
- GMP Certified according to NSF/ANSI 455-2 for dietary supplements
- ARTG from TGA-Australia
- FDA Food Facility registered
- FDA (Food and Drug Administration) approved for Food and Dietary Supplements
- TGA (Therapeutic Goods Australia) approved
- NSF/ANSI 306, section 6 and 455-2 GMP Certifications
- Marine Stewardship Council Certification (MSC)
- Friends of the Sea (FOS)
- Manufacture IFANCA Halal Certified Products
- Approved Establishment for Export to the EU
- WDA Permission for wholesale of medicinal products
- Certificate of GDP Compliance
- Permission according to §3 Narcotics Act
- GMP manufacturing licence under application
