Good Manufacturing Practices in Clinical Trails : A Brief overview... by Ms Pooja K Arora, Msc (Clinical Research)

Clinical trial results are accepted by the reviewing healthcare authorities, when the trial has been conducting keeping focus on the GMPs:

Clinical trials share a mandatory bond or better called forced bond with Good Manufacturing Practices. Executing CTs as per the GMP norms and regulations is a necessity, a requirement for validation of the CT results and much needed trait for a trial to be regarded credible. Clinical trials or trials executed on human volunteers could be and should only be conducted as per the most recent and updated GMP guidelines, this works to safeguard the health of the volunteers and most importantly is assurance of humanitarian, research based and non-commercial intent of the trial conducting group or organisation.

While the linkage between Good Manufacturing practices and Clinical Trials is a much debated and hot topic of the dynamic healthcare industry, it is true that the need of this co-application is a demand which cannot be neglected. Clinical trials are not simple lab procedures or sample testing methods but these time consuming trials include usage of new drugs and new treatment methods on humans actually suffering from the disease. When we say, human volunteers are used for testing it becomes clear how important it will be to safeguard their health and how easy it will to face litigations in case of breach of guidelines.

How GMPs find application in Clinical Trials?
Investigational medicinal product (IMP) is the hero of the story. IMPs are replicas of the newly researched drugs which are tested for their safety and efficacy on diseased population. In order to best safeguard the health interest of volunteers it is must to have the IMP (to be used for a trial) manufactured as demanded by the GMP guidelines applicable to that category of drugs. We know GMPs are formed and regulated to avoid production of spurious or sub -standard drugs with potentials of causing harm to the user.

When we talk about human volunteers, it includes completely healthy volunteers to diseased as well as terminally ill patients who have by will agreed to be a part of the clinical trial and contribute to the research of new and better treatment methods. With all the human volunteers, both the drug research companies and the groups conducting trials (sometimes CTs are outsourced) hold moral responsibility to provide them properly manufactured non-spurious IMPs which have adequate quality standard. This quality standard in turn can be guaranteed if GMPs are vigilantly used and followed during production of the IMPs.

Quality requirements need to be fulfilled for complete binding to the moral responsibility:
A scientists subject knowledge, understanding, critical analysis of the situation (disease in this case), thought process and application of research tools is the key to development of newer and better medicines. But stemming this research process by boundaries of GMP guidelines is must for patient’s safety. Bluntly but appropriately, scientific research in not creative science, though hit and trial works sometimes to get positive results but when working with live test samples (human volunteers), creativity cannot not be left un-checked and boundaries to research procedures and manufacturing process are more than essential. Technical process of drug manufacturing thus should be critically reviewed to be complementing the GMP guidelines.

The major hindrances in path of GMP application can be anything from laziness, negligence to mere commercial interest:

Reluctance or forced negligence creeps in when profits are seemingly less. Yes, commercial profits are a culprit too. GMPs are to be followed when the manufactured IMPs are to be packaged, stored and transported to other places (across states or even outside country- in case of outsourced CTs). Contaminated or spoiled trial material cannot be used. This step is more essential as this is the most reluctantly handled aspects of new drug trials. This happens because of meagre quantities of the IMPs which need to be transported as compared to huge commercial quantities of existent branded drugs. The step involves more effort and less profit, sometimes negative revenue if the new drug fails to be efficacious enough to be launched in the market. Proper testing and good manufacturing process should be followed by an appropriate distribution channel where the temperature, humidity and other key constraints attached to shelf life and validity period of the investigational product are properly taken care of.

Lack of global or universal guidelines is another big hindrance posed to compliance of GMPs during execution of clinical trials. Different countries have different health authorities and each one has its own version of legislative guidelines. Like say if European Union’s health agency accepts trial results for which the trial material has been manufactured following guidelines given in the EU GMP guide. The same will not be accepted by US FDA which might have other guidelines which need to be followed. For global acceptance, globally acceptable trial results and better applicability of CT results, a single set of GMP would be a better solution.

Giving in to quality assurance while manufacturing or testing new drug fetches better reputation and moral satisfaction for all involved in the process!

While the drug is still in trial phase (Phase I, II or II of CTs) other good practices like Good Laboratory Practice, Good Quality Control Lab Practice, Good Documentation Practice also come into play and must be appropriately followed. Be it commercial production or for clinical purpose the drug produced is to be used by a human and apt care should be taken that it is manufactured under optimum conditions. Like we mentioned other good practices, Good Documentation finds role during the conduct of the trial. This helps ensure the patient’s data is accurately recorded, volunteer’s information remains confidential and the trial results are credible. For all this set rules and guidelines need to be followed. Execution of each step of the trial and each process of drug manufacture as per the guidelines for sure adds to the total time gone into the trial, it sometimes also makes procedures slow but the end result is authentic and credible. The trial results thus attained free from guilt of harming any life. The increased time span, extra cost incurred or added effort gone into conducting trials with cGMP (clinical Good Manufacturing Practice), GLP (Good Laboratory Practices), GDP (Good Documentation Practices) and other quality assurance systems in place come with the satisfaction of releasing into the market a thoroughly tested treatment option which will help the diseased lives for several years to come.

Posted by Placement Manager IGMPI

Telephone: +91 8130749005.