THE DAYS WHEN I WAS IN J & .J PHARMACEUTICAL COMPANY -by LAW JIA JUIN

A. BRIEF BUT IMPORTANT BACKGROUD AND INTRODUCTION

I am currently working in the world largest pharmaceutical company, named Johnson- & Johnson (J & .J). I work in the Quality Assurance department. My job is to assure that all the drugs manufactured by the production lines are of outstanding quality with good purity, desired doses, and acceptable shelf life. I also play an important role in assigning a name and identityto an unknown batch of product, before they can be labeledand marketed. As a senior pharmacist I play an important role in remaining the good reputation of my company, allowing my company to survive in the competition among different world class pharmaceutical companies like Merck & co and Plizer.

Throughout the 30 years of working experience, I had been equipped with advance and updated knowledge, analytical skills as well as problem solving ability .I am here to share some recent problem which,I had faced in my company, I had also written some solutions which I used to address this problem.

Recently, some spectroscopic and analytical devices in my company had stopped functioning due to the damaged circuit boards. The engineers said it will definitely take some time before the devices can be completelyrepaired. This is really a nightmare for our department, as we were having a batch of pending active ingredient to be analyzed and identified by us. And the worse had came to worst, when the company told us that this analysis had to be done immediately. Thus we were forced to do the analysis using some non-spectroscopic technique. So what is the non-spectroscopic technique you can apply if you face the same problem as me in the future?

First of all check for the identity “claimed” by the manufacturing line, like in my case the product claimed by them was Para -Aminosalicylic Acid (4-Amino-2hydroxybenzoic acid) or P.A.S. This step is important because it gives us a clue on how and where to start the analysis.

Tuberculosis has becoming a world -wide health problem. Tuberculosis is a lung infection caused by  Mycobacterium tuberculosis. Para-Aminosalicylic Acid or PASis one of theanti-tuberculosisdrug. It is used prior to the administration of other first line anti-tuberculosis drugs like Rifampicin, isoniazid, Ethambutol, Streptomycin and Pyrazinamide. It is also useful in the treatment of multi -drug resistant tuberculosis infection.  It is a bacteriostatic anti-tuberculosis drug. It works by three mechanisms. It is a useful bacteriostatic anti-tuberculosis drug because it works by inhibiting the synthesis of folic acid, thus the replication of DNA in the nucleus of bacterial can be stopped. It also works by inhibiting the cell wall synthesis, making the Mycobacterium tuberculosis to be lysed. Thirdly, it works by reducing the iron uptake by M.tuberculosis,thus preventing the formation of iron chelating growth factors by the bacterials. PAS is marketed in many different trade name like PASER, PARASAL, and NAMASOL. PAS is available in many different dosage forms, but the most commonly used dosage form is granule. PAS is made into granule dosage form with a protective film coated on it. This protective film is acid resisting but can be degraded easily in the presence of neutral or alkaline medium. This protective film is important because PAS is acid –labile and need to be protected from gastric acid in stomach. Thus active ingredient -PAS, will only be released in small intestine.


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