Auditaje

Remote Audits have changed from a slightly futuristic tool into something perfectly suited for sent times. Importers and contract manufacturers maintain constant supply chain and may efore continue their business activities without holding times. On-line audit allows for no y in the project.

REMOTE AUDITS FOR PHARMA INDUSTRY - DON'T
LET THE PANDEMIC STOP YOU!

Due to the Covid-19, on-site audits of GxP systems have become difficult or even impossible.
This became a huge challenge for importers or manufacturers of the medicinal products, for whom maintaining a steady supply chain is a must. With all the travel restrictions in-place and safety concerns Remote Audits emerged as necessary and viable alternative with following advantages:
equally valid as on-site audits for OP declaration and honored by key agencies (e.g. EMA). cost effective and safe for both sides (the audited place and the auditor). help avoiding delays and allow maintenance of constant supply chain. allow maintenance of the quality of API and drug manufacturing in the Covid-19 times.

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GLP AUDITS

WHAT IS GLP AND WHY IS IT IMPORTANT

Nowadays, especially in Western societies, we become more and more aware that animals are not „just meal". They are intelligent beings, with emotions and feelings. We try to protect their rights and avoid exploiting them. But being an inventor of a new drug, a new therapeutic molecule, would you take the risk of giving it to a human volunteer only after testing it in vitro on cell lines or tissue cultures? Without the knowledge of how this drug behaves in a living organism as a whole? Probably not, and therefore we still need at least some animal testing in drug development.
To limit the non-clinical studies to the minimum, we need to make sure that the experiments are conducted in a way that assures their high quality - and that is the main goal of the rules of Good Laboratory Practice (GLP). The first draft of GLP principles was developed by the Food and Drug Administration (FDA), nearly 50 years ago, as a result of controls in several laboratories testing the toxicity of chemicals, which revealed major malpractices. Later on, in 1981, the Organisation for Economic Co-operation and Development (OCD) created international standards of LP [https://www.oecd.org/chemicalsafety/testing/good-laboratory-practiceglp.hm]
GLP is a system for ensuring the quality and credibility of the obtained research results, from the moment of their planning, to the proper storage of source data and reports, so that it is possible to trace the course of the research or its complete reconstruction. The basic aspects

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BENEFITS OF GLP AUDITS

One could wonder - if there is the GLP certification, is it necessary to audit the laboratories, which perform the tests? The answer, of course, is yes. As mentioned earlier, not all studies conducted during the drug development need to be done in GLP-certified facilities, but it is expected that all of them are done in the spirit of GL. Our experienced team of auditors can make sure of that for you.
The GLP auditors at Hub Net Scientific Pharma are experienced in non-clinical in vitro and in vivo studies, as well as the analytics of samples from clinical trials. We have experience working in the GLP environment. Even if the facility is not GLP-certified, we make sure that the following aspects are in accordance with the GLP guidelines:
Standard operating procedures (SOPs) and related documents;
Overall company and facility organization;
Staff qualifications;
Study records keeping.
And finally, we issue a recommendation if the laboratory concerned could be contracted with the study that the sponsor plans to perform.