Papers by brahmaiah bonthagarala
International Journal of Advances in Scientific Research, May 30, 2015
The purpose of this work is to present an introduction and general overview on process validation... more The purpose of this work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process especially tablet manufacturing process with special reference to the requirements stipulated by the US Food and Drug Administration (FDA).Quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. In pharmaceutical industry, Process Validation performs this task to build the quality into the product because according to ISO 9000:2000, it had proven to be an important tool for quality management of pharmaceuticals.
Zenodo (CERN European Organization for Nuclear Research), Sep 3, 2022
Despite the appreciable efforts by government, immunization programs of India are not able to ach... more Despite the appreciable efforts by government, immunization programs of India are not able to achieve its target, but also lagging behind to achieve immunization coverage as par with the global immunization coverage of 85%. It is important to understand the knowledge attitude and practice of parents towards immunization of their children and develop and implement suitable strategies to improve the immunization coverage. The strategies can vary based on the culture and education of the population. In this study, we observed that personalized education to the parents is very useful in complete immunization schedule. To promote safe and quality use of vaccines, starting from cold chain management of vaccine to AEFI reporting, appropriate educational interventions are necessary. HCPs communication can help any parents to gain confidence on vaccination, which leads to a successful immunization program of a country. Inadequate knowledge about reporting process, lack of time and interest were the identified challenges contribute to low reporting rate by spontaneous reporting method. Awareness and sensitization on identification and reporting of AEFIs is essential depending on the role played by each HCP on the immunization process.
Zenodo (CERN European Organization for Nuclear Research), May 5, 2022
Wellbeing and viability of a medication item for use in people is fundamental before the medicati... more Wellbeing and viability of a medication item for use in people is fundamental before the medication item can be endorsed for import or assembling a new medication. For this each nation has administrative power bears the obligation of assessing whether the exploration information of new drug/item upholds the security and viability to serve general wellbeing. Administrative issue branch of an organization assumes a crucial part of working in understanding to the principles, guidelines and rules laid out by the directing organizations of various nations. This article expects to look at changed parts of medication endorsement process in USA,
Zenodo (CERN European Organization for Nuclear Research), Aug 7, 2018
Common Technical Document (CTD) provides a standardized structure for regulatory submissions that... more Common Technical Document (CTD) provides a standardized structure for regulatory submissions that is acceptable in all ICH countries. Although the CTD makes multinational filings easier, there are significant differences in the dossier submission requirements in these countries. This study put forth the differences in registration requirements for generics in United States, Europe and India. Generic drugs in US they are approved under the Abbreviated New Drug Application. Bioavailability and Bioequivalence study data is critical in the generic drug approval process. For marketing authorization of the generic medicinal product in Europe, the applicant should submit abridged application to the relevant authority. The ability to accommodate country specific requirements and understand regulatory differences will have a substantial impact on the success of its multi country submissions strategy. Generic manufacturers must file an Abbreviated New Drug Submission (ANDS), and the CDSCO is controlled and governed by Directorate General of Health Services which comes under ministry of health and family welfare, Government of India. Medicinal products are highly regulated in the European Union (EU) and are subject to a separate, complicated system of approval procedures.
The Pharma Innovation Journal, 2018
Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equiv... more Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two drugs are bioequivalent it means that they would be expected to be, for all intents and purposes, the same. In determining bioequivalence between two drugs such as a reference drug (Brand) and potential to be test drug (marketed generic drug), pharmacokinetic studies are conducted whereby, each of the drugs are administered in a cross over study to volunteers subjects (healthy individuals). Serum/plasma are obtained at regular intervals and assayed for parent drug (metabolites) concentration. Blood concentration levels are neither feasible nor possible to compare the two drugs, then pharmacodynamic endpoints rather than pharmacokinetic end points are used for comparison. For a pharmacokinetic comparison, the plasma concentration data are used to assess key pharmacokinetic parameters such as area under the curve (AUC), peak concentration (Cmax), time to peak concentration (Tmax), and absorption lag time (tlag). Testing should be conducted at several different doses, especially when the drug displays non-linear pharmacokinetics. If 90% Confidence interval for the ratio of the geometric least square means of natural log transformed Cmax, AUC0-t and AUC0-inf of Test and Reference drugs are within 80.00% to 125.00%, then bioequivalence will be establish.
Zenodo (CERN European Organization for Nuclear Research), Sep 3, 2022
In order to market any medical device, marketing authorization from Regulatory authority is requi... more In order to market any medical device, marketing authorization from Regulatory authority is required. The process of gaining authorization is complex, multistep and requires review of information by competent authorities. Upon scrutinizing the information furnished by Manufacturer, marketing authorization is granted by the concerned Regulatory authority. In the USA, manufacturers are required to apply to United States Food and Drugs Application (USFDA) for Marketing Authorization. There are two types of applications in USA; 510 (k) and Pre-Market Application (PMA). In EU, National Authorities give approval for marketing medical devices. A system of third party compliance is followed, where Notified Bodies (Third Party) ensure Quality Assurance, pre and post approval. In India, Central Drugs Standard Control Organization (CDSCO) approves devices for sale and import. Medical Devices are regulated under CLAA scheme. The Drug Controller General of India (DCGI) is the central licensing authority for medical devices. This paper attempts to capture information on regulations of Medical Device in three regions namely; USA, EU and India and compare provisions of Market authorization in the respective regions, and further, for the readers, make this complex subject easier to grasp.
Zenodo (CERN European Organization for Nuclear Research), May 5, 2022
The human world and man lifestyle was completely shaken and changed with the outbreak of novel co... more The human world and man lifestyle was completely shaken and changed with the outbreak of novel corona virus (Covid-19) which begun in Wuhan, China in Dec 2019 was declared a pandemic by World Health Organization on 11 March 2020. To stop this uncontrollable and life-threatening virus scientists from all over the world started research to find a solution or cure to this evil virus and to protect mankind. In this process vaccine was proved to be a better solution to put a check to this pandemic virus. In this article we wanted to brush up your knowledge on covid-19 and various vaccines in market and to educate the regulatory process for approval of sputnik V in India.
Nutraceuticals, characterized as any food or part of food which gives medical advantages includin... more Nutraceuticals, characterized as any food or part of food which gives medical advantages including counteraction or treatment of sickness, have arisen as a need for buyers in created as well as creating nations. With changing way of life and related illnesses, useful fixings like nutrients, minerals, amino acids, unsaturated fats and Probiotics, and so on have likewise turned into a piece of this classification. Around the world administrative specialists are zeroing in on the Product Quality and Safety as these items are intended for human utilization. As food items are coming to starting with one country then onto the next, keeping up with wellbeing and quality principles according to different administrative rules set by the particular states becomes significant; which can be a genuine driver for the business development. Food varieties and food propensities in the present way of life have lead to the aggravations in an in a perfect world healthfully adjusted body. In this manner in such state if "food be your medication" then, at that point, it would be incredible to accomplish a solid body and psyche. This article gives a short survey osf the Nutraceuticals guideline set out by US Food and Drug organization in USA and in India by Food Safety Standard Authority of India. It fundamentally centers around the similitudes and contrasts of nutraceuticals administrative system and construction in USA and India, with orchestrated specialized prerequisite for enlistment of nutraceutical item in this market.
Indian drug area is rising quickly and there is a need of administrative issues experts to give t... more Indian drug area is rising quickly and there is a need of administrative issues experts to give the current necessities of businesses for the worldwide rivalry. An administrative issue is a fairly new calling which has created from the longing of legislatures to shield general wellbeing. The regions where government controlling the security and viability of items are drugs, veterinary meds, clinical gadgets, pesticides, agrochemicals, beauty care products what's more, corresponding medications. The drug organizations answerable for the revelation, testing, clinical preliminaries, creation, production and showcasing of these items additionally need to guarantee that they supply items that are protected and make a beneficial commitment to general wellbeing and government assistance. Administrative undertakings experts are the connection between drug ventures and overall administrative offices. They are expected to be knowledgeable in the regulations, guidelines, rules and direction of the administrative offices. There is a developing need to fuse the current prerequisites of drug ventures in the norm educational plan of drug store schools to set up the understudies with the furthest down the line advancements to serve the enterprises. The current article talks about the administrative instruction also, its need, learning assets, courses accessible, schedule substance, and open positions in administrative issues.
Today millions of patients depend on medical device based treatment for the management and diagno... more Today millions of patients depend on medical device based treatment for the management and diagnose of several diseases. Quality and safety of device is depends upon the regulatory guidelines. Therefore a law containing adequate guidelines of rules and regulations are required for monitoring the entry of such devices into the use in public health. The regulations define requirements of medical device design, development and manufacture to ensure that products reaching market are safe and effective. Presently in India regulatory body CDSCO is governing regulation for regulation of devices which with time, amendment introducing in the law will provide safety assurance to public health. The United States has long had the world's most successful medical device (or med tech) industry, with the European Union (EU) serving as its largest export market. The trading bloc's reputation for relatively timely market approvals has long benefited these U.S. manufacturers. However, the EU's soon-to-be-implemented Medical Device Regulation (MDR)-an overhaul of the previous med tech regulatory regime-may present a number of obstacles for U.S. and other med tech firms that could limit their access to a critical market. The present review discuss about the classification of medical devices and regulations aspects in India, USA and European Union.
Drug impurities are the natural and inorganic undesirable synthetic compounds which are found in ... more Drug impurities are the natural and inorganic undesirable synthetic compounds which are found in dynamic drug fixing after combination or create during plan advancement. These impurities seriously influence the wellbeing and viability of created drug item.
The entire globe has been impacted by the COVID 19 pandemic for the final remaining one year. We ... more The entire globe has been impacted by the COVID 19 pandemic for the final remaining one year. We are currently planning and controlling antibodies later managing fatalities and numerous morbidities. Fundamental individual well-being training is a necessity for the infection's annihilation and is a huge and significant component in the infection's loss. Immunizations that give some degree of insurance against the Covid are inadequate in covering the whole populace of a country. As indicated by WHO, the created nations are presently in a situation to immunize most of their residents, emerging nations too come up short on means to inoculate even their medical services staff. The primary point of this research is to dissect the immunization drive in India. For the most part Secondary information has been use to in this exploration paper. The result of the exploration will be useful for the public authority for definitive preparation of such pandemic in future.
In todays day to day life the use of cosmetics and beauty products in both male and female person... more In todays day to day life the use of cosmetics and beauty products in both male and female persons had become a common scenario of life as a part of fashion and to groom themselves as a attractive person in society. But all these products are made up a wide range of chemical compositions which may lead to serious skin diseases if used excessively. So different countries use different set of rules and guidelines to control the chemical composition and side effects of cosmetics. in this article we are going to learn few guidelines of some important counties like India, USA and European Guidelines.
Packaging is a key for sale, safety and success. Like other packaged goods, pharmaceuticals packa... more Packaging is a key for sale, safety and success. Like other packaged goods, pharmaceuticals packaging need to be in such a manner that it will provide speedy packaging, protection, identification, product quality, patient comfort, display and needs of security. Advancement in research of pharmaceuticals development had always being dependent on the packaging technology. Maintaining integrity of pharmaceuticals during storage, shipment, and delivery is assured by quality of packaging available. This article reviewing current pharmaceutical packaging trends and predicting the packaging outcomes in future.
The United States Food and Drug Administration (USFDA) is one of the main regulated agencies wher... more The United States Food and Drug Administration (USFDA) is one of the main regulated agencies wherein the submission and approval of the new drugs is done. This review is based on the process of submission to the ANDA as per FDA norms as described in submission in Federal Food, Drug, and Cosmetic Act (FD and C Act). No drug would exist in the market until it gets accepted by regulatory authorities. The ANDA submission is for those firms seeking to copy
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Papers by brahmaiah bonthagarala