# https://totalpharmaceuticaltopics.com


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- [What is Personalized Medicine ?](https://totalpharmaceuticaltopics.com/2024/08/what-is-personalized-medicine/): This is a revolutionary approach in healthcare that customizes medical treatment to the individual characteristics of each patient. Fig.: – 01 Personalized Medicine In other words, Personalized medicine also known as precision medicine. It involves the customization of healthcare, with decisions and treatments being tailored to the individual patient by integrating genetic, environmental, and lifestyle factors. KEY ASPECTS OF PERSONALIZED MEDICINE Genetic Profiling:  This can lead to more effective and targeted therapies. Patient’s genetic makeup helps healthcare provider to; ✅    Predict; How they will respond to specific medications, ✅    Identify; Their risk of developing certain diseases, and ✅    Determine; The […]
- [Pharmaceutical Science: What You Need to Know?](https://totalpharmaceuticaltopics.com/2024/07/pharmaceutical-science-what-you-need-to-know/): Pharmaceutical science covers a diverse field focused on the discovery, development, and evaluation of drugs intended for medical purposes. It is the combination of elements of biology, chemistry, pharmacology, and technology to formulate medications that enhance human health effectively.  From initial Research and Formulation to Clinical Trials and Regulatory Approval, pharmaceutical scientists play a crucial role in every stage of drug development.  Their efforts not only tackle existing health issues but also drive forward medical innovation, striving to expand treatment choices and improve global quality of life. In continuation to introduction of Pharmaceutical science, we can say it is a […]
- [5 Common Issues Encountered During Process Validation and solutions](https://totalpharmaceuticaltopics.com/2024/06/5-common-issues-encountered-during-process-validation-and-solutions/): Process validation is a critical aspect of pharmaceutical manufacturing, ensuring that products meet their intended quality standards consistently. However, the path to successful process validation is often troubled with challenges. In this article, we will explore common issues encountered during process validation and provide practical solutions to overcome them. 1.    Incomplete or Inadequate Validation Protocols.2.    Inconsistent Data and Poor Data Integrity3.    Equipment and Instrumentation Failures4.    Variability in Raw Materials5.    Process Deviations and Non-Conformances Issues Encountered During Process Validation and solutions Incomplete or Inadequate Validation Protocol Lack of comprehensive documentation can hinder the validation process. Incomplete or poorly organized records […]
- [What does SISPQ stands for? In Pharmaceutical Industry](https://totalpharmaceuticaltopics.com/2024/05/what-does-sispq-stands-for-in-pharmaceutical-industry/): When we discuss the pharmaceutical manufacturing, SISPQ is very important topic of discussion. It adheres the basic principle and objective of Pharmaceutical Manufacturing i.e.  “The pharmaceutical industry aims to guarantee patient safety by producing a safe product which has been tested according to the highest standard of current scientific knowledge and which is approved by the authorities.” The SISPQ fulfill the requirements of “Good manufacturing practice (GMP)” set by the various regulatory agencies all over the world. Elements of SISPQ   Elements of SISPQ   In simple words if we see SISPQ full form, SISPQ stands for Safety, Identity, Strength, Purity, […]
- [Understanding Impurities in Drug Substance and Control Strategies](https://totalpharmaceuticaltopics.com/2024/04/understanding-impurities-in-drug-substance-and-control-strategies/): In General terms Impurity is referred as something, which is not pure. Some substance / component that may affect the SISPQ (Safety, Identity, Strength, Purity and Quality) of a drug substance/drug products (Ref.USP). Therefore, studies of impurities are one of the most important works in the development of APIs and drug products. We will understand the below details under this article; ·         Definition of Impurities·         Classification of Impurities·         Regulatory Requirements·         Risk assessments & Control strategies Impurities in Drug Substance and Control Strategies Definition of Impurities In the Pharmaceutical manufacturing, impurities can be […]
- [What is Regulatory Dossier in Pharmaceutical Industry?](https://totalpharmaceuticaltopics.com/2024/03/what-is-regulatory-dossier-in-pharmaceutical-industry/): Regulatory Affairs is a profession, known as a bridge / a channel of communication, between the Regulatory Agency and the organization seeking approval for new pharmaceutical products.  It plays an important role in Product Life Cycle management stages from “Drug development” to “Commercialization”. For the getting approval of new Products in various countries all over the world, there is an approval procedure; having some set of procedures governed by the respective country regulatory agencies.  New pharmaceutical products registration is required with the complete details of Product and manufacturer in the form of a dossier, The process of registration of Pharmaceutical […]
- [Green Chemistry in Drug Substance Synthesis](https://totalpharmaceuticaltopics.com/2024/03/green-chemistry-in-drug-substance-synthesis/): The concept of Green Chemistry accepted by the scientific community, the technical Green Chemistry evolution is yet to achieve with the appropriate attention and effort which only possible through education and awareness. Green Chemistry has the potential to transform the pharmaceutical industry and drug manufacturing in the future. It provides benefit both environmentally and economically. It will result in transforming the traditional pharmaceutical industries into sustainable ones and sustainability of the environment. So in this article we will try to understand the green chemistry for its concept, definition and the green solvent. What is GREEN CHEMISTRY? Green Chemistry is a concept, which is focused […]
- [Artificial intelligence and Automation in pharmaceutical 💊 industry](https://totalpharmaceuticaltopics.com/2024/03/artificial-intelligence-and-automation-in-pharmaceutical-%f0%9f%92%8a-industry/): Artificial Intelligence and Automation in Healthcare, these are key step for Revolutionizing Pharma Artificial-intelligence-in-pharmaceutical-Industry How to define Artificial intelligence and Automation: Artificial intelligence is a broader concept that covers the simulation of human intelligence by machines, while Automation refers to the use of technology to perform tasks with minimal human intervention. AI systems are typically more flexible and capable of learning and adapting, while automation systems are often simpler and more static. To understand the difference between these two terms refer below tabulated details; Aspect Artificial Intelligence (AI) Automation Definition Simulation of human intelligence processes by machines Use of technology to perform tasks with minimal human […]
- [What is the difference between clinical trial & clinical research?](https://totalpharmaceuticaltopics.com/2024/02/what-is-the-difference-between-clinical-trial-clinical-research/): These two terms are differ in scope and methodology, clinical trials and clinical research are essential components of medical innovation. In this article we will try to define clinical trial & clinical research in comparatively in brief.   Clinical research is a wide range of scientific investigation that aims to comprehend illnesses, medical procedures, and therapeutic methods. They adhere to strict ethical and legal requirements and follow a controlled methodology with human participants. Clinical trials offer vital evidence for the use of successful medical interventions in healthcare practice, whereas clinical research develops knowledge.  Fig.: 1 Clinical Trial & Clinical Research ——————————————————————————————————————– Clinical research: […]
- [What is Marketing Authorization in Pharmaceutical Industry?](https://totalpharmaceuticaltopics.com/2024/01/what-is-marketing-authorization-in-pharmaceutical-industry/): In the world of pharmaceutical industry, Marketing Authorization term is being used for formal approval process, by which various regulatory agency grant permission for the commercial distribution and sale of a Pharmaceutical Product. Marketing Authorization is an official document issued by the regulatory agency for the purpose of marketing of a product after evaluation for Quality, Safety and Efficacy. What is Marketing Authorization in Pharmaceutical Industry?  The Pharmaceutical Regulatory Agencies are responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). The process for having marketing authorization for any pharmaceutical product is a critical and rigorous step. Which goes […]
- [New Chemical Entities (NCEs) in Pharmaceutical Drug Development](https://totalpharmaceuticaltopics.com/2023/12/new-chemical-entities-nces-in-pharmaceutical-drug-development/): When it comes to the world of pharmaceuticals, you may have heard the term “New Chemical Entity” / NCE under Drug Development procedure. But what exactly does this term mean? In this article, we will explore the understanding on NCEs, exploring their significance & understanding their role in the development of innovative medicines.  Fig.1 : New Chemical Entities (NCEs) Defining NCEs A New Chemical Entity; often abbreviated as NCE under the topic drug development, This term generally used by pharmaceutical community, researchers & scientists for a novel compound or molecule that has never been used in a drug before. In simpler […]
- [5 Common Challenges in Pharma Drug substance Process Validation](https://totalpharmaceuticaltopics.com/2023/12/5-common-challenges-in-pharma-drug-substance-process-validation/): Pharmaceutical process validation is a critical aspect of drug substance manufacturing; that ensures the consistency and reliability of production processes.  Pharmaceutical process validation However, various challenges may arise during this validation process. Here, are five common challenges in pharmaceutical process validation for drug substance manufacturing and potential strategies to overcome them: 1. Process Variability/Complexity 2. Scale-Up Issues 3. Analytical Method Validation 4. Regulatory Compliance 5. Lifecycle Management —————————————————————————————————– 1. Process Variability Challenge: Inherent variability in raw materials, equipment, and environmental conditions can lead to process variations.  Solution: Implement robust process controls, conduct a thorough risk assessment, and employ statistical tools like design of experiments […]
- [10 Key Steps for Successful Process Validation in Pharma](https://totalpharmaceuticaltopics.com/2023/11/10-key-steps-for-successful-process-validation-in-pharma/): In the ever-evolving landscape of the pharmaceutical industry, ensuring the quality and reliability of processes is paramount. One crucial aspect that stands at the forefront is the process validation—a meticulous journey that guarantees the efficiency and safety of pharmaceutical manufacturing. 10 Key Steps for Successful Process Validation in Pharma In this article, we will unravel the intricacies of process validation in pharma, exploring the 10 key steps that pave the way for success. From understanding critical process parameters to navigating FDA regulations, let’s embark on this journey together. Step 1: Setting the Foundation –  Step 2: Navigating the Regulatory Landscape […]
- [Clinical Trials: A Key to Pharmaceutical Development / Advancement](https://totalpharmaceuticaltopics.com/2023/11/clinical-trials-a-key-to-pharmaceutical-development-advancement/):   Introduction to Clinical Trial?   When we talk about the pharmaceutical development, Clinical trial is a significant term. What is clinical trial? This term can be defined as; the clinical study of health and illness in people.  Fig. 1 : What is Clinical Trial? In previous article pharmaceutical development, we understand the Path to Pharmaceutical Development via “Drug Substance and Drug Product Manufacturing Flow: Discovery to Delivery. In continuation we will have an idea about Clinical Trial. There are two core words in clinical research: i.e. Observational Studies and Clinical Trials. Observation studies involves the monitoring activity of people in […]
- [Pharmaceutical Quality Management System: Excellence in Drug Manufacturing](https://totalpharmaceuticaltopics.com/2023/10/pharmaceutical-quality-management-system-excellence-in-drug-manufacturing/):  A strong and effective quality management system (QMS) is perhaps more important than ever in the fast changing pharmaceutical industry of today. Pharmaceutical manufacturing is built on a solid QMS, which makes sure that each stage of production complies with strict quality standards, legal requirements, and patient safety. Pharmaceutical firms are currently carefully designing their Quality management systems to outperform industry standards and provide unmatched perfection in drug production. Figure: 01 Pillars of Pharmaceutical Quality Management System The Pillars of Pharmaceutical Quality Management System 1. Stringent Regulatory Compliance Navigating the intricate web of pharmaceutical regulations and guidelines is no small […]
- [The Evolution of Drug Substance Development](https://totalpharmaceuticaltopics.com/2023/10/the-evolution-of-drug-substance-development/):  The development of drug substances has evolved significantly over the years. In the past, drug substances /API  were often discovered through serendipity or by isolating compounds from natural sources. However, modern drug discovery and development have become more systematic and technologically advanced. Figure 01:  Evolution of Drug Substance Development The development of drug substances has evolved significantly over the years. In the past, drug substances /API  were often discovered through serendipity or by isolating compounds from natural sources. However, modern drug discovery and development have become more systematic and technologically advanced. In the pharmaceutical industry’s endeavor to research and produce effective […]
- [Drug Substance in Pharmaceuticals!! Unveiling Its Vital Role](https://totalpharmaceuticaltopics.com/2023/10/drug-substance-in-pharmaceuticals-unveiling-its-vital-role/): In the intricate world of pharmaceuticals, every pill, capsule, or vial of medicine begins its journey as a carefully crafted concoction of various components. At the heart of this intricate process lies a fundamental element known as the “drug substance” or “active pharmaceutical ingredient” (API). In this comprehensive article, we will delve into the significance of drug substances in pharmaceutical manufacturing, exploring their definition, importance, manufacturing process, regulatory aspects, and the evolving landscape of drug substance development. Join us on this in-depth journey to uncover the critical role that drug substances play in delivering safe and effective medicines to patients worldwide. […]
- [Computer System Validation: Navigating Regulatory Compliance](https://totalpharmaceuticaltopics.com/2023/09/computer-system-validation-navigating-regulatory-compliance/): Computer system plays a key role in many businesses from managing critical data to managing complex processes. The seamless integration of advanced technology & regulatory compliance is important in the ever-changing world of pharmaceuticals, biotechnology & medical devices. Compliance to regulatory agencies regulations & recommendations is not only needed; but it is also important to ensure the integrity, security & reliability of these systems. In this broad article we tried to dig into the subject of “Computer System Validation (CSV)” within the context of FDA standards, highlighting its importance, difficulties, and best practices. Figure:01 Computer System Validation: Navigating Regulatory Compliance In […]
- [Drug Substance and Drug Product Manufacturing Flow: Discovery to Delivery](https://totalpharmaceuticaltopics.com/2023/08/drug-substance-and-drug-product-manufacturing-flow-discovery-to-delivery/): In the world of pharmaceuticals, the drug substance manufacturing process is a critical component in bringing life-saving medicines to patients. This complex process involves several steps, adherence to stringent rules, and upholding the highest standards of quality. This process is based on the basic Good Manufacturing Practice (GMP) principles i.e. SISPQ; which means a drug substance / drug product should be manufactured in such a way, that achieve Safety, Identity, Strength, Purity and Quality. In this article, we will go through with the various phases from drug development through the ultimate delivery of the active pharmaceutical ingredient (API), taking a […]
- [What is Difference? Verification v/s Validation in Pharmaceutical Industry](https://totalpharmaceuticaltopics.com/2023/07/what-is-difference-verification-v-s-validation-in-pharmaceutical-industry/): In the pharmaceutical industry, term verification and validation are being often used, this article is furnished just for the understanding the difference between these two i.e. Verification V/s Validation. Figure: 1 Verification and Validation How to Define Verification and Validation? Validation and verification these are two separate / individual processes, each of these have their own meaning. These terms are very closely related but different in terms of their objective and methods. In Pharmaceutical industry these are terms are vital for ensuring the Identity, Strength, Quality, safety and efficacy of pharmaceutical products i.e. Drug substances / Drug Products and medical devices. […]
- [Importance of computer system validation (CSV) in Pharmaceutical Industry](https://totalpharmaceuticaltopics.com/2023/06/importance-of-computer-system-validation-csv-in-pharmaceutical-industry/): In the previous article we got the introduction of Computer system validation, along with the approach objective and requirement. Furthermore we will see the importance of Computer System Validation (CSV) in Pharmaceutical Industry.  Figure-01: Computer system and Validation Why computer system validation (CSV) is important? Computer system validation (CSV) is a compliance activity, documented evidence “To ensure that a computer system consistently performs as intended in a specific environment including its hardware, software. And it is also required to ensure those particular computers systems are being used in the process / activity are fit for their intended purpose and are […]
- [Computer system validation (CSV) in Pharmaceutical Industry !! Introduction](https://totalpharmaceuticaltopics.com/2023/05/computer-system-validation-csv-in-pharmaceutical-industry-introduction/): Computerized systems used in the various stages in pharmaceutical Industry. In the modern era Automation / computerization is the become trend or we can say necessity to achieve accuracy / precision in the various tasks. In pharmaceutical Industry computerized systems are being used at various stages of Drug substance / Drug Product manufacturing including Research and Development; Production, clinical trials, Analytical Testing and Distribution of Drug substance / Drug Products and medical devices. Fig. 1: Computer System Validation (CSV) Introduction WHAT IS COMPUTER SYSTEM…..? Computerized systems include hardware, software, and firmware components that must be validated throughout their lifecycle. When we talk about the Lifecycle approach then […]
- [Ultraviolet (UV) Filtration-Pharmaceutical Purified water system component](https://totalpharmaceuticaltopics.com/2023/02/ultraviolet-uv-filtration-pharmaceutical-purified-water-system-component/): In General, Pharmaceutical Purified water system is system made-up with the composition of various sanitization and filtration system. We had information about those systems in previous articles as a part of series of Pharmaceutical Purified Water Generation system for Drug substance. In continuation here we will a brief information on one of the major and important component of Pharmaceutical Purified water generation system i.e. Ultraviolet (UV) Filtration. What is ultraviolet (UV) FILTRATION? Ultraviolet (UV) filtration process that uses ultraviolet light to purify / disinfect the source water. This filtration system plays very crucial role in Purified water generation system. Ultraviolet (UV) Filtration is known to have remove […]
- [ELECTRO DEIONIZATION UNIT (EDI) - Pharmaceutical Purified water system](https://totalpharmaceuticaltopics.com/2023/02/electro-deionization-unit-edi-pharmaceutical-purified-water-system/): In the series of articles on Pharmaceutical Purified water system for manufacturing of Drug substance / Drug products, previously we had information on other sections/part of the Purified water generation system i.e. Gramicid, Sand Filtration, Water Softner, Micro Filtration and Reverse Osmosis. Another one of the important component of purified water system i.e. ELECTRO DEIONIZATION UNIT (EDI) we will have a brief introduction, requirement, benefit and more details. What is ELECTRO DEIONIZATION UNIT (EDI)? EDI is one of the major and important water treatment unit of Pharmaceutical purified water generation system. As the name indicates it’s a deionization process, which […]
- [What is Reverse Osmosis in Pharmaceutical Purified water system?](https://totalpharmaceuticaltopics.com/2023/01/what-is-reverse-osmosis-in-pharmaceutical-purified-water-system/): Reverse Osmosis;  In continuation to series of articles on Pharmaceutical Purified Water system, here we will discuss and have basic knowledge on one of the important Component of Pharmaceutical Purified Water generation system for manufacturing of Drug substance and drug products. Reverse Osmosis (RO) is one of the efficient system / component for the generation of pharmaceutical purified water / Process water this is being frequently employed in pharmaceutical Industry to get the desired quality / Processed water to achieve the acceptance criteria established by Various Regulatory bodies. Let’s have Few Q’s and A’s on Reverse osmosis………… What is Reverse Osmosis? […]
- [What is Dosing? in Pharmaceutical Purified water system](https://totalpharmaceuticaltopics.com/2022/11/what-is-dosing-in-pharmaceutical-purified-water-system/):  DOSING SYSTEM In Pharmaceutical Process Water Generation system, Dosing is the process of addition of the external chemical components to the water as a part of the process water treatment process. This is required to achieve the aim; to have purified water. There are three types of dosing system required After Micro filtration and Before Reverse Osmosis. These are; Figure:01Dosing System in Operation Flow of Process water system ANTISCALANT DOSING What is Antiscalant? Antiscalant are the chemicals. This is used in the water treatment before the feed water enters to the process of Reverse Osmosis. Antiscalant are a family of chemicals […]
- [What is Filtration? Pharmaceutical Purified Water System components](https://totalpharmaceuticaltopics.com/2022/10/what-is-filtration-pharmaceutical-purified-water-system-components/): A Component of Pharmaceutical Purified Water system for manufacturing of Drug substance and drug products. This Article is summarized with the Details of various FAQ’s on Filtration like; ❓ What is Filtration? ❓ What is Micro-filtration? ❓ What is Ultra-filtration? What is Filtration? After the water softening process, water purification process follows the filtration process, there are two types of membrane filtration is being used in the generation of pharmaceutical grade purified water. Figure: 01 Pharmaceutical water generation – Membrane process What Is Micro Filtration (Membrane)? Micro filtration is the pressure driven separation process.  This process physically removes suspended solid from water, through a micro […]
- [Water softener: Pharmaceutical Purified Water System components](https://totalpharmaceuticaltopics.com/2022/09/water-softener-pharmaceutical-purified-water-system-components/): A Component of Pharmaceutical Purified Water system for manufacturing of Drug substance and drug products. Pharmaceutical Water Some FAQ’s are tried to answered under this Article like; ❓ What is water softening? ❓ Why Water softening is required? ❓ What principle works behind water softener? ❓ What is used as Ion exchanger in water softener? ❓ What are the components of water softener? What is water softening? Water softening is a process of Ion exchange in which the ions of Calcium (Ca2+) and magnesium (Mg2+) and sometimes iron are removed. Calcium and magnesium are often referred to as ‘hardness minerals’. Why Water softening is required? Hard water has high concentrations of […]
- [Multi Grade Filter (MGF) - Pharmaceutical Purified Water system components](https://totalpharmaceuticaltopics.com/2022/09/multi-grade-filter-mgf-pharmaceutical-purified-water-system-components/): MULTI GRADE FILTER (MGF) A Component of Pharmaceutical Purified Water system for manufacturing of Drug substance and drug products. What is Multi Grade Filter (MGF)? This is Known as Sand Filtration. Multi Grade Filter consists of vertical or horizontal pressure sand filters that contain multiple layers of coarse and fine sand (pebbles and gravels) in a fixed proportion. Figure: 01 Sand Filtration: Multi Grade Filter (MGF) What is Purpose of Multi Grade Filter (MGF) usage? MGF is being used for filtration process of water. Objective to perform this operation in the water purification process is to remove of suspended solids and turbidity in the water. This […]
- [Gramicid - Pharmaceutical Purified Water system components](https://totalpharmaceuticaltopics.com/2022/08/gramicid-pharmaceutical-purified-water-system-components/): GRAMICID A Component of Pharmaceutical Purified Water system for manufacturing of Drug substance and drug products. What is Gramicid? GRAMICID is a multi-component complex formulation of concentrated Hydrogen Peroxide (48 %) and Silver (500 ppm) in cationic form.  Figure: 01 Gramicid Composition What is Gramicid Dosing in water purification process? GRAMICID dosing is required in the water purification process to perform disinfection process of raw water /potable water. This is effective on Viruses, Spores, Bacteria, E-coli, Mould, Pseudomonas, Fungi, Yeast, and Protozoa & Biofilms. Hence, it is required to remove the presence of Microbiological, Organic and inorganic impurities. Why gramicid dosing is required for water purification process? […]
- [What is Operational Flow of Pharmaceutical Purified water system?](https://totalpharmaceuticaltopics.com/2022/08/what-is-operational-flow-of-pharmaceutical-purified-water-system/):  Pharmaceutical Purified water system: What is Operational Flow ?? Figure: 01 Pharmaceutical purified water In the previous article we understood the Fundamental Introduction of Pharmaceutical Purified water system, Here in this article we will get some more on the same topic to understand the Operational flow of the pharmaceutical process water system. Below is the operational flow of Pharmaceutical Purified water generation system which is being followed in the pharmaceutical industry. The operational flow is consists of difference stages for the treatment to input water i.e. Raw water / potable water. Figure: 02 Operational Flow of Pharmaceutical Purified water generation system […]
- [What is Purified water system? A Fundamental Introduction](https://totalpharmaceuticaltopics.com/2022/07/what-is-purified-water-system-a-fundamental-introduction/): Water is the most common and important Component, being used in the pharmaceutical industry. This is being widely used as a Input Raw material, ingredient and as solvent, purpose is also very vast in regards of its usage. Various sector of pharmaceutical manufacturing industry like Raw material manufacturing, intermediate manufacturing, API manufacturing and formulation intakes the water as a major commodity. Figure: 01 Water for Pharmaceutical manufacturing Usage As this component i.e. water is being used in the life saving drugs manufacturing so, cannot be used as such in raw condition. In this regard this article will help us to understand […]
- [Validation study: Why Three batch for validation study?](https://totalpharmaceuticaltopics.com/2022/06/validation-study-why-three-batch-for-validation-study/): In this article we will try to understand the fundamental concept of three batches for Validation study; or more correctly we say Process performance qualification (PPQ). This is very important to know “what we are doing and why we are doing” to come on fruitful conclusion. So, we will continue the topic with the small background on regulatory requirements. Fig. 01: Validation-Three batch concept In the world of pharmaceutical manufacturing, Validation of manufacturing processes is a requirement of the Current Good Manufacturing Practice (CGMP) regulations (21 CFR 211.100 and 211.110) and is considered an enforceable element of current good manufacturing practice […]
- [N-Nitrosamine impurity? An overview: Pharmaceutical Manufacturing](https://totalpharmaceuticaltopics.com/2020/09/n-nitrosamine-impurity-an-overview-pharmaceutical-manufacturing/): Figure-01: N-Nitrosamine impurities: An overview Nitrosamine impurities, More correctly N-nitrosamine impurities, Now a days very hot and burning issue in the pharmaceutical industry and a topic for curious discussion among the pharmaceutical professionals. So for the understanding on what actually nitrosamine impurities are and how it is having critical and adverse impact on human health, we have taken a brief review on this topic. I hope you all will like it. In this article we will have an insight view on nitrosamine impurities for; its chemistry, behavior, acceptance etc. We will have answers of basic questions like what it is exactly, what […]
- [Sartan: What are sartans?](https://totalpharmaceuticaltopics.com/2020/09/sartan-what-are-sartans/):   Now a days sartan family of medicine are on tip of the tongue of pharmaceutical professionals in the view of potential nitrosamine impurities issues and challenges to control it. Here, we will have a brief overview on the -Sartan family of medicine. To get the answers of very common questions about the Sartans i.e. what are sartans? For what it is being used? What are sartan drugs and usage? -Sartan is the suffix given to the drugs which belongs to a class of medicine known as Angiotensin II receptor blockers (ARBs). Like; Valsartan, losartan, Irbesartan, Candesartan, Azilsartan etc. Name of […]
- [What is Process Validation? What are the Types of validation?](https://totalpharmaceuticaltopics.com/2020/08/what-is-process-validation-what-are-the-types-of-validation/):   In previous article we understood what is pharmaceutical validation study and scope (phase)of validation.  We also saw the history of validation concept.  In this article we are going to understand the definition of process validation as per various regulatory agencies, type of process validation and objective of process validation along with it’s advantages. Definition of Process validation: ICH (International Conference on Harmonization): In 2000, ICH defines definition of process validation in cGMP Guidance document ICH Q7 that “Process Validation (PV) is the documented evidence that the process, operated within established parameters, can perform effectively and reproducible to produce an intermediate […]
- [What is Validation? Basic overview](https://totalpharmaceuticaltopics.com/2020/08/what-is-validation-basic-overview/): Validation Study: Basic overview  This Article is written here to have an overview on the validation Study, now a day’s validation became an integrated part of cGMP. As we all know that the pharmaceutical industries are manufacturing the life saving drugs, hence the key objective set by the pharmaceutical industry is to manufacture products of required attributes and quality with consistency, at the lowest conceivable cost.  Validation study is the first requirement of any regulatory authority to give approval of commercialization / Market authorization. Various regulatory authorities defined the guidance on the Validation study and its approach for execution; here […]
- [Pharmaceutical Drug substance (API) and Drug Product: Definition](https://totalpharmaceuticaltopics.com/2020/08/pharmaceutical-drug-substance-api-and-drug-product-definition/): What is Pharmaceutical Drug Substance / API (Active Pharmaceutical Ingredient) And Pharmaceutical Drug Products? This article is for understanding what is Pharmaceutical drug substance / Active Pharmaceutical ingredients (API) and drug product. These are two different terms that can be easily understood by the picture depicting above. Drug Substance i.e. API (Active Pharmaceutical Ingredient) is the Start point for the manufacturing of any medicine which results the manufacturing of end product i.e. Drug Product. What is Definition of Drug substance (API)? “An active pharmaceutical ingredient (API) is a substance which is used in the preparation of a drug product. API and excipients (inert materials) […]
- [What is Product Lifecycle Management..? An Overview](https://totalpharmaceuticaltopics.com/2020/06/what-is-product-lifecycle-management-an-overview/): What is product Lifecycle management? This could be the basic question which is linked with the life of a product. In general term this is the life of a product which describes the life of a product, right from it initiation / inception to its end. Journey of a product is just like human life and could be correlated very easily. As Human life starts up with the born of a baby, it further goes to the next stages of the life via growth and development of mind and body, similarly a product enters in to life cycle right from […]
- [What is Research and development (R&D)?](https://totalpharmaceuticaltopics.com/2020/06/what-is-research-and-development-rd/): Research and development is a process by which a organization acts to get new knowledge that it might use to create new technology, products, services, or systems that it will either use or sell. Research and development (R&D) includes activities that organization undertake to innovate and introduce new products and services. It is often the first stage in the development process. The term R&D is associated with; Advancement Innovation New Idea New concept Competitiveness Study and knowledge Examination/test Practice development We hope this article of total pharmaceutical topic helps you to refreshing your knowledge bucket; other useful articles may uplift […]
- [What is Quality Policy?](https://totalpharmaceuticaltopics.com/2020/05/what-is-quality-policy/): Quality Policy; When we talk about the Quality management system (QMS) in pharmaceutical industry, Quality Policy is an important term within it. This term can be easily understood by some of the below questions. What is the definition of Quality Policy? Term “Quality Policy” is self defining term, means a policy or statement on Quality. In Quality management system (QMS) this term is used for a documented procedure, to give you an idea about commitment and strategic direction of the organizational management towards Quality of the product.  This should be the aim of the organization. WHO says “A brief statement (Quality Policy […]
- [Pharmaceutical regulatory authorities All over the world](https://totalpharmaceuticaltopics.com/2020/05/pharmaceutical-regulatory-authorities-all-over-the-world/): What are the Pharmaceutical regulatory authorities  Pharmaceutical regulatory authorities are established by the various countries with the objective, to ensure the quality, safety and efficacy of the pharmaceutical product, these products includes medicines and medical devices both. These Pharmaceutical regulatory bodies are working on certain set of the rules and regulation those are needs to be followed by the pharmaceutical manufacturer. These rules and regulation are related to the drug product registration, manufacturing, distribution, price control, marketing, research and development, and intellectual property protection. World Health Organization (WHO) World Trade Organization (WTO) International Conference on Harmonization (ICH) World Intellectual Property […]
- [Elements of Quality management system: An overview](https://totalpharmaceuticaltopics.com/2020/05/elements-of-quality-management-system-an-overview/): Quality management system (QMS) is the linking system between customer requirement and customer satisfactions. Universal goal of quality system is the consistent manufacturing of safe and effective products. Quality management system As per ICH Q10 : management responsibility, Continual improvement of process performance, continual improvement of product quality and continual improvement of pharmaceutical quality system via management review are the key components of the pharmaceutical quality management system. What are the Elements of Quality management system? Quality management system is having four arms by which it runs; each part having similar king of Impact on the development and run of Quality […]
- [What is Quality Management system for pharmaceutical industry?](https://totalpharmaceuticaltopics.com/2020/04/what-is-quality-management-system-for-pharmaceutical-industry/): Figure:01: Pharmaceutical Quality Management System Quality management system in pharmaceutical industry is a wide range concept, directly or indirectly influence the quality of the product. Quality management is defined as the aspect of management that determines and implements the “quality policy” i.e. overall intention and direction of an organization regarding quality as formally expressed and authorized by top management. Quality Management of the pharmaceutical product is the prime responsibility of the manufacturer. Manufacturing of medicinal products should be performed with identity, quality, purity and efficacy; having objective to ensure that products are consistently produced and controlled to the quality standards appropriate […]
- [Biosorption: Effective method for removal of heavy metal from Aqueous medium](https://totalpharmaceuticaltopics.com/2020/03/biosorption-effective-method-for-removal-of-heavy-metal-from-aqueous-medium/): Environmental contamination by toxic heavy metals like copper, lead, zinc, cobalt, mercury and chromium, due to various anthropogenic activities has become one of the serious problems of worldwide concern Presence of these metals in aqueous streams has been responsible for several health problems associated with animals, plants and human beings. “Biosorption” an effective method for removal of heavy metal from Aqueous medium The problem of Lead [Pb(II)] pollution due to use in Pb service pipes, particularly with soft water was the first recognized metal pollution. Other sources of Pb(II) pollution are battery industry, auto-exhaust, paints, etc. Lead poisoning in human […]
- [Pharmaceutical Quality Management System: An overview](https://totalpharmaceuticaltopics.com/2020/03/pharmaceutical-quality-management-system-an-overview/): Pharmaceutical Quality Management is a comprehensive concept, which covers all matters, which independently or jointly influence the pharmaceutical product quality.  In totality this concept defines an organized arrangement made with the purpose of ensuring that medicinal products are of the quality required for their anticipated or intended use. Therefore Good Manufacturing Practice incorporated in Quality Management System (QMS). Pharmaceutical Quality Management System: An overview Management has the responsibility to make sure QMS are set up in such a way that ensures state of control, for; Good manufacturing practices, Stockholder value,  Achieving Goals,  Continual improvement.  There are number of companies which are […]
- [Coronavirus (COVID-19): Facts for Precautions & Care](https://totalpharmaceuticaltopics.com/2020/03/coronavirus-covid-19-facts-for-precautions-care/): Facts – Precautions and information  ‘New coronavirus: COVID-19’ Fig.: 01 – COVID-19 ·         New coronavirus spreads in cold regions only? Fact # 1 The New coronavirus can be transmitted in areas with hot and humid climates. ·        Eating garlic help prevent infection with the new coronavirus? Fact # 2 Garlic is a healthy food that may have some antimicrobial properties. However, there is no evidences form the current outbreak that eating garlic has protected people from the coronavirus. ·         Coronavirus can be transmitted by mosquito? Fact # 3 To the date there is no information nor evidences to suggest that the new coronavirus could be […]


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