Contract / contract laboratory audits
Worldwide auditing of microbiological, chemical and physical laboratories
Control, inspection and testing are inseparable components of drug manufacturing and the pharmaceutical industry.
In this industry, numerous controls and tests of active ingredients, raw materials, in-process controls and even microbiological tests can be outsourced by manufacturers to external contract laboratories.
These contract laboratories take responsibility for the analysis of representative samples to ensure the safety, accuracy, compliance and quality of the manufacturing process and products.
Testing of APIs, excipients, primary packaging materials, finished products and intermediates is essential for the pharmaceutical industry.
These tests must comply with strict regulations and requirements of 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 recognized methods form the foundation of every specialized pharmaceutical laboratory and ensure the safety and conformity of your products.
Our GMP audits of contract laboratories cover all relevant and important aspects that a qualified pharmaceutical laboratory should have.
These include agreements and contracts between the client and the laboratory, clear responsibilities, Standard Operating Procedures (SOPs), thorough record keeping, equipment, validation of various test methods, qualification of personnel, instruments and laboratories, reporting and facilities – to name but a few.
Our highly qualified team of experts is able to audit all kinds of pharma-relevant contract laboratories, be it microbiological, chemical or physical laboratories.
Our team is made up of PhD chemists, biochemists, former quality assurance (QA) staff 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 record all important aspects during an audit and prepare detailed, high-quality reports that are made available to you.
Our globally available expert team of highly qualified and experienced auditors responds flexibly to your individual needs and guarantees you simple and rapid processing. Order your next GMP audit for your contract laboratory with us and ensure quality and compliance at the highest level.
