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PRODUCT QUALITY COMPLAINT MANAGEMENT IN PHARMACEUTICAL INDUSTRY – AN OVERVIEW

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ABOUT AUTHOR:
Himani Devliyal
Department of Pharmacology,
Delhi Institute of Pharmaceutical Sciences and Research
Delhi University, New Delhi
himanidevliyal@gmail.com

ABSTRACT
This article covers fundamental basics of product quality complaint. We would learn what product quality is all about, how the product quality complaints are made, processed, investigated and changes implemented. Also we would go through the basics of case processing, how the complaints are classified, categorized based on the priority and then investigated. We would also go through the formal process of responding to the customer and increasing their faith in the company.
A PQP (product quality problem) can be defined as an issue arising due to change in color, odor, appearance, quality, safety and effectiveness of a product. A PQP is a grave concern and is directly related to the efficacy and safety of a drug.


A REVIEW ON GOOD MANUFACTURING PRACTICE (GMP) FOR MEDICINAL PRODUCTS

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ABOUT AUTHORS:
Vikash Kumar Chaudhari1*, Vijay Yadav2, Praveen Kumar Verma1, Amit Kumar Singh2
1Department of Pharmaceutical Chemistry,
2Department of Pharmacognosy,
Kunwar Haribansh Singh College of Pharmacy, Jaunpur, U.P.
*vikashk464@gmail.com

ABSTRACT
Good manufacturing practices (GMP) is a part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP guidelines provide minimum requirements for pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.


GOOD CLINICAL PRACTICE (GCP): A REVIEW

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ABOUT AUTHOR:
Bushra Shamim
Department of Pharmaceutics, Faculty of Pharmacy,
Hamdard University, New Delhi.
bushrashamim21@gmail.com

ABSTRACT
Good Clinical Practice (GCP) is an international ethical and scientific quality standard designed to conduct, performance, monitor, audit, record, analyse and report clinical trials. It protects the rights, integrity and confidentiality of trial subjects. Clinical research trails are increasingly playing a role in various medical disciplines.  GCP guidelines are used in clinical trials through out the globe with the main aim of protecting and preserving human rights. In this review article the historical background and the events that led up to the formation of these guidelines, key trial activities and principles of GCP are discussed.


IDENTIFICATION OF BACTERIAL SPECIES BY COMBINED BIOINFORMATIC AND POLYMERASE CHAIN REACTION

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About Authors:
Emanual Michael Patelia, Bushra Ahmed, Muhammad Javaid, Jayesh Patel, Rakesh Thakur, Mishra Trinath
Department of Pharmacology, University of Bedfordshire, England,
United Kingdom, LU1 3JU
ricky.emanual@gmail.com

Abstract
The identification will be carried out by comparing a potential PCR product obtained from an unknown species with other PCR products specific to 5 known species, using the same five set of pairs of primers specific of these five species respectively. This implies that each PCR product obtained for each species has to be specific to each species and can be considered as a marker in this exercise. This specificity will be based on the uniqueness of the chosen template that is to be used for each PCR. In addition, since the PCR products will not be sequenced, they will be differentiated by their size, which will be identified by agarose gel electrophoresis. The PCR product can only be used as a marker that defines a species if the amplified sequence is unique to this species. Therefore, the first step in this exercise will be to identify a suitable sequence to amplify for each species. Following the identification of a suitable template, the size of the PCR will have to be defined; since the comparative analysis will be based not only on the presence of a product but also its size, all PCR products should have different sizes identifiable on agarose gel. Since the size of a PCR product is defined by the location of primers along the sequence, the second step in this exercise will be to design suitable primers. Finally, having defined specific template and primers for each species, PCR will be carried out using the DNA of unknown species as a template with all five sets of primers so that a successful PCR product and its size would identify the unknown species as one of the five species.


PHARMACEUTICAL MARKETING AND ETHICAL CODES: MYTHS OR REALITY WITH SPECIAL REFERENCE TO ALLAHABAD, UTTAR PRADESH

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About Authors:
*Pradhyuman Singh Lakhawat, Poonam Vishwakarma
Research Scholar (Management) SHIATS,
Allahabad, Uttar Pradesh
pradhyuman.sngh@gmail.com

Abstract
Marketing is very important part of any organization for its existence in the market. The main strength of organization can measure on two basis first human resources and second on the basis of market share. While marketing is the major part then it should be follow the business ethical norms which are the guidelines for what is wrong and what is right in the business. But now a day’s mostly pharmaceutical in the pressure of more selling, more profit and for making the big share they are neglecting these codes. And whole pharmaceutical industry in the race of competition forgets one thing that is this marketing service is directly relate with the human life. Medicines are nectar but if it is in wrong form it can be poison for humans. So I am trying to give a small picture of current pharmaceutical marketing services and ethical codes.


RATIONAL USE OF MEDICINES: CAN WE PROMOTE

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About Authors:
Languluri Reddenna
Department of Pharmacy Practice,
Rajiv Gandhi Institute of Medical Sciences,
Kadapa, Andhra Pradesh, India-516003
reddennapharmd@gmail.com

Abstract
Rational use of drugs can be defined as prescribing the right drug, in sufficient dose for the adequate duration and suitable to the clinical requirements of the patients at least cost. Causes of irrational use comprise not have of knowledge, skills or self-determining information, unhampered accessibility of medicines, overburden of health personnel, unsuitable promotion of medicines and earnings motives from selling medicines. In appropriate drug usecan have dire consequences; it has been associated with hospitalization and evencaused deaths of inpatients in health carefacilities. A variety of situations and circumstancespromote irrational use of medicines.Rational use of medication saves lives, confines undesired toxicity, adverse events and maximize on the benefits that can be imitative from best use of medications. According to surveys conducted in 2004 by HAI Africa and WHO in 11 Sub-Saharan Africa countries in 2004, the average accessibility of the essential medicines in public health facilities was below 70%. Communication between professionals and consumers is essential to the enhancement of rational use of medicines. It is essential to recommence collaboration of physicians and pharmacists concerning accurate and competent drugs prescribing. Governments, private health care institutions, entity health care providers and patients all have an accountability to endorse rational use of medicines. Professionals should provide information to the customers about the name of the medicine, the intention for which the medicine is being taken, dose, frequency of use, and duration of use.


SOY-BASED DIET: A MESMERIZING TRIUMPH FOR WELLNESS

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There are three topics that can cause derision and division at any coffee or dinner table across the Western world: religion, politics, and soy. The humble soybean does have a noble and ingrained place in our world today and, whether you are pro or no, it’s almost unavoidable. Soy is everywhere - from your soy milks and tofus to the more discreet soy lecithin used to prevent compounds from separating during the cooking process. 


CHALLENGING ROLE OF PHARMACIST IN HEALTH CARE THE FUTURE PROSPECTS

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MODERN PHARMACIST:
One who is able to provide the patient oriented services as in developed countries is called as a modern pharmacist. Such services start from obtaining patients medication history to the feedback from the same after discharge. The componential characteristics that a modern hospital pharmacist must possess include:
1. Professional knowledge
2. Computer / IT acquaintance & skill
3. Counseling and communication skills


SMOKING-HAZARDOUS TO OUR HEALTH: ‘AN OVERVIEW’

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About Authors:
Babu Lal
Department of Pharmacy,
Tirupati College of Polytechnic & Pharmacy,
Sardulgarh Road, Ratia, Dist. Fatehabad (Haryana), Pin-125051
lab_85@rediffmail.com

Abstract:
The word of smoking, drinking smoke is very famous all over the globe. The practice of Dhumrapana is commonin human beings from the last two thousand year’s to induce consciousness. Soon, the recreational use of tobacco became a part of the elite culture throughout the world and shows remarkable value in large scale productivity (multibillion dollar business)[1]. Botanically, tobacco is achieved from the dried leaves of Nicotiana tobacum Linn (var.macrophyll, N. chinensis Fisch), commercially cultivated on small scale tolarge extent in China, United States and India. The tobacco contains pyridine-piperidine type of alkaloids, among which the most prominent is nicotine. Nicotine, well known as natural botanical insecticide weighs 0.6-3.0% of dried leaves which is synthesized in roots and accumulated in the leaves. Smoking was practiced by early priests to diagnose, heal the bizarrepersons and to fend off evil spirits. As time passes, smoking tobacco becomes more than just a ritualistic comportment. However, the pattern has now been endorsed to the growing numbers of ailments, birth defects, and deaths. Worldwide, approximate 4.9 million and alone in United State (US), smoking is the reason for 434,000 deaths per year [2] and every day14,000 peoples diebecause of smoking-related diseases. Today, medical studies have proven that smoking tobacco is among the leading sources of lung cancer, heart attacks, chronic obstructive pulmonary disease(COPD), and erectile dysfunctionand can also lead to teratogenic effect. Moreover, active smokers are not the only ones in severe danger but people lives around them, bystander’s or passive smoker affected much more accumulating the health-related effect brought about by the emitted dangerous chemicals (smoke) from a cigar or cigarettes. In fact, 33 percent of the nonsmoker population in the US is exposed with environmental cocktail of tobacco smoke [3].


NEXT LIPITOR® WILL ALSO BE FROM METABOLIC THERAPY

Introduction
At least one article is seen in newspaper on obesity on daily basis; no other disease is searched (and articles are read on) as frequently as obesity. Such is the menace of obesity that even fast food giant McDonald's has put an advice in few of its offices “not to eat too much fast-food”. Obesity is defined as BMI (body mass index) 30kg\m2 or more. A person with a BMI between 25 and 29.9 are considered over weight but not obese. BMI is a simple index of weight-for-height that is commonly used to classify overweight and obesity in humans. It is also defined as a person’s weight in kilograms divided by the square of his height in meters (kg\m2). As per world health organization (WHO), BMI greater than or equal to 25 is overweight and BMI greater than or equal to 30 is obese. Obesity is a foremost health problem not only in developed nations but also in developing countries. It increases the risk of other diseases like diabetes, cardiovascular ailments, fatty liver and some forms of cancer1. Obesity is now so common in various geographies that it is beginning to replace conditions arising from malnutrition and infectious diseases as the most significant contributor to ill health. Obesity is measured using BMI and further evaluated in terms of fat distribution via the waist–hip ratio and total cardiovascular risk factors2. BMI is closely related to both percentage body fat and total body fat3. The global epidemic of obesity results from an amalgamation of such factors as genetic susceptibility, increased availability of high-energy foods and diminished need of physical activity in prevailing situation in modern society. Obesity is no more a cosmetic issue affecting certain individuals, but a pandemic threatening global well being because it exacerbates a large number of health-related problems, both independently and in association with other ailments4,5.