Intertek Pharmaceutical Services launches expert extractables and leachables testing services for compliance with new Korean Pharmacopeia requirements
01 Oct 2025
Ensuring the safety and quality of pharmaceutical products, packaging, and drug delivery systems for the evolving Korean market.
Reinach, Switzerland: Intertek, a leading Total Quality Assurance provider to industries worldwide, is pleased to announce the launch of expert extractables and leachables (E&L) testing services from its Good Manufacturing Practice (GMP) pharmaceutical services laboratory in Reinach, Switzerland, to help clients meet new mandatory Korean Pharmacopeia (KP) requirements.
The Korean Ministry of Food and Drug Safety (MFDS) has partially revised the Korean Pharmacopeia (Notice No. 2025‑18, issued 27 March 2025), making E&L testing mandatory for (i) new drugs applying for marketing authorisation in Korea and (ii) imported pharmaceutical products. The amendment takes effect three months after its publication—27 June 2025—and is intended to ensure the safety and quality of pharmaceutical packaging and drug‑delivery systems.
Under the revised pharmacopoeia, manufacturers and importers must provide comprehensive E&L data for their regulatory submissions. This includes assessing potential interactions between drug formulations and packaging materials to mitigate risks associated with product contamination and patient safety.
With over 30 years of expertise in E&L analysis and toxicology consulting, Intertek delivers customised solutions that meet the revised KP, including method development, validation, and advanced testing to create tailored protocols for diverse pharmaceutical packaging systems, ensuring accurate, reproducible, and compliant results. Intertek’s Centre of Excellence for E&L testing operates under current GMP standards and aligns with major global regulatory frameworks, including those of the US FDA, EMA, and Swissmedic. In addition to the new KP E&L requirements, the Centre of Excellence provides support to global standards for E&L, such as USP <1663> and <1664>.
Ashleigh Wake, Business Development Director, UK and Switzerland and Chemicals and Pharma, Intertek, said: “As pioneers in pharmaceutical testing, we are committed to ensuring that our clients meet the highest regulatory standards. The introduction of mandatory E&L testing in the Korean market underscores the importance of proactive risk management and product safety. Our dedicated team is equipped with state-of-the-art facilities to deliver accurate and comprehensive E&L assessments, supporting our clients in navigating complex regulatory landscapes."
Ross McCluskey, Executive Vice President, Europe, Middle East and Africa and Government and Trade Services, Intertek, commented: "This GMP service expansion reflects our commitment to advancing safe and effective medicines by providing high-quality, precise laboratory support that helps clients accelerate development and meet the highest standards of quality and compliance."
To complement its analytical services, assessments of potential risks of E&L exposure in patients are performed by Intertek’s Toxicological Risk Assessment Centre of Excellence (TRACE). These assessments support regulatory approval and ensure the continued delivery of safe and effective pharmaceutical products to market.
Learn more about the specialist analytical and formulation support Intertek's GMP-compliant laboratories and expert scientists offer for the pharmaceutical, biotechnology, and drug delivery industries: Intertek.com/pharmaceutical
Please refer to the Korean translated version here.
For Media Information:
Please contact:
Lorna Kettle
ECA Marketing Director, Intertek Pharmaceutical Services
T: +44 (0) 116 296 1620
E: lorna.kettle@intertek.com
About Intertek
Intertek is a leading Total Quality Assurance provider to industries worldwide.
Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers' operations and supply chains.
Intertek is a purpose-led company to Bring Quality, Safety and Sustainability to Life. We provide 24/7 mission-critical quality assurance solutions to our clients to ensure that they can operate with well-functioning supply chains in each of their operations.
Our Customer Promise is: Intertek Total Quality Assurance expertise, delivered consistently, with precision, pace and passion, enabling our customers to power ahead safely.
intertek.com
About Intertek Pharmaceutical Services
Intertek’s pharmaceutical services locations include Melbourn, Cambridge (UK), Manchester (UK), Basel (Switzerland), Whitehouse, (New Jersey, USA), Mumbai (India) and Melbourne, (Australia).
Intertek’s scientists continue to lead the way in pharmaceutical testing with the launch of specialised E&L services tailored to meet the requirements of the revised Korean Pharmacopeia. By partnering with us, pharmaceutical companies can ensure compliance, mitigate risks, and maintain the highest standards of product quality and safety.
Intertek.com/pharmaceutical