Contract / Commissioned Laboratory Audits

Control, testing and analysis are inseparable components of medicinal product manufacturing and the pharmaceutical industry. In this sector, numerous controls and tests of active substances, raw materials and in-process controls through to microbiological testing can be outsourced by manufacturers to external commissioned laboratories. These contract laboratories take responsibility for the analysis of representative samples and are intended to ensure the safety, accuracy, compliance and quality of the manufacturing process and the products.

For the pharmaceutical industry, the testing of APIs, excipients, primary packaging materials, finished products and also intermediates is of essential importance. These tests must comply with strict regulations and requirements of the EU Good Manufacturing Practice (GMP) Part I and II as well as ICH Q2, Q3, Q7, Q14 and Good Laboratory Practice (GLP). Validated and internationally recognised methods form the foundation of every specialised pharmaceutical laboratory and ensure the safety and conformity of your products.

Our GMP audits at contract laboratories cover all relevant and important aspects that a qualified pharmaceutical laboratory should exhibit. These include agreements and contracts between the client and the laboratory, clear responsibilities, standard operating procedures (SOPs), careful records, equipment, validation of various test methods, qualification of the personnel, instruments and laboratories as well as reporting and facilities – to name just a few.

Our highly qualified team of experts is able to audit all possible pharma-relevant contract laboratories, be they microbiological, chemical or physical laboratories. Our team is made up of doctoral chemists, biochemists as well as former employees in quality management (QA) and Qualified Persons (QPs) with extensive experience in Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP). With the help of this competent team we capture all important aspects during an audit and write detailed, high-quality reports that are made available to you.

Our worldwide available team of experts consisting of highly qualified and experienced auditors responds flexibly to your individual needs and ensures easy and swift handling for you. Order your next GMP audit for your commissioned laboratory from us and secure quality and compliance at the highest level.