eChapters

1. Pharmaceutical Quality System

1.1 Introduction

This document establishes a new ICH tripartite guideline describing a model for an effective quality management system for the pharmaceutical industry, referredto as the Pharmaceutical Quality System. Throughout this guideline, the term “pharmaceutical quality system” refers to the ICH Q10 model.

ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Standards Organisation (ISO) quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”. ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements. ICH Q10 is not intended to create any new expectations beyond current regulatory requirements. Consequently, the content ofICH Q10 that is additional to current regional GMP requirements is optional.

ICH Q10 demonstrates industry and regulatory authorities’ support of an effective pharmaceutical quality system to enhance the quality and availability of medicines around the world in the interest of public health. Implementation of ICH Q10 throughout the product lifecycle should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.

AI-driven animal husbandry is advancing through machine learning, computer vision, IoT, big-data analytics, wearable devices and automated equipment. This chapter considers future applications for monitoring animal health, behaviour, nutrition, reproduction and environmental conditions. Predictive systems can support early disease detection, precision feeding, improved breeding and reduced production costs. However, high implementation costs, data privacy, inadequate infrastructure and limited digital knowledge remain significant obstacles, particularly in developing regions. Future research should prioritize affordable, user-friendly and explainable technologies suited to smallholders. Ethical AI, climate adaptation, multimodal data integration, omics analysis and interdisciplinary collaboration among animal scientists, engineers, policymakers and farmers are identified as essential research directions.

IoT networks and smart sensors enable continuous livestock monitoring, overcoming the delay and subjectivity associated with manual observation. This chapter reviews sensor types, communication systems, cloud and edge computing, and their applications in animal-health and behaviour tracking. It proposes a framework integrating multimodal sensors with IoT networks and machine-learning models such as CNNs and LSTMs. The system can detect abnormalities, predict health conditions and provide real-time decision support. Practical benefits include earlier intervention, improved welfare, reduced labour and more efficient production. The chapter also addresses implementation problems, costs, connectivity, data security, technical reliability and ethical considerations associated with constant digital monitoring of animals.

Livestock farms generate large quantities of physiological, environmental, behavioural and production data through sensors, IoT devices and management records. Raw information must be processed before it can support dependable analysis. This chapter explains data cleaning, missing-value treatment, noise reduction, anomaly detection, integration, normalization, transformation and dimensionality reduction. It also discusses feature extraction, categorical encoding, variable transformation and temporal-feature analysis. Machine learning, AutoML, Python, R and other analytical platforms are introduced as tools for preparing livestock datasets. Applications include disease prediction, yield improvement and movement monitoring. The chapter concludes by examining scalability, data quality, privacy and ethical challenges in intelligent livestock analytics.

Precision feeding aims to supply animals with appropriate nutrients according to their changing physiological state, growth, production and environment. Conventional feeding plans are often static and may lead to waste, increased costs and environmental losses. This chapter introduces an AI-enabled framework integrating animal data, feed composition, growth characteristics and external factors. Regression, ensemble learning and other machine-learning models predict feed intake and weight gain, while linear programming and metaheuristic optimization generate efficient allocation plans. A decision-support system provides recommendations in real time. The approach can improve feed conversion, nutrient utilization, profitability and sustainability while reducing overfeeding, resource wastage and the environmental impact of livestock production.

Introduction:The phenomenon of reproduction is an important aspect, which needs special attention in livestock farming to achieve optimum productivity and increase the economic status of the farmers. Variousgynaecological problems like anestrus, repeat breeding, endometritis,  retention of placenta, etc reduce thereproductive performance in farm animals. Besides indirect reducing the milk yield, it also creates financial burden on the farmers due to high cost of therapeutic drugs prescribed for their treatment. The use of various hormonal preparations and antibiotics has been critical in treating these disorders inthe farm animals. However, herbal treatments render a holistic approach to manage the reproductive problems with minimalcost and no side effects.
1. Name of the condition: Anestrous
About the condition/definition: Anestrus is a reproductive cycle dysfunction in which an animal does not display the obvious symptoms of estrus. It is one of the major limiting factor in achieving better reproductive
performance in farm animals.
Etiology and pathogenesis: Expression of estrus is controlled by secretion of reproductive hormones. Any disturbance in their secretion due to the effect of either ofSeason, stress, uterine diseases, poor management techniques, inadequate nourishment, etc., delays the process.The animals with smooth non-functional ovary are said to true anestrous, whereas absence of estrus due to retained CL on ovary due to uterine pathology are false anestrous.

1.    ———— is a synthetic antimicrobial drug against M. tuberculosis.
    A.    Penicillin    B.    Tetracycline
    C.    Erythromycin    D.    Isoniazid
Ans.    D.
2.    Which of the antibiotic is not used as a food preservative ?
    A.    Pimaricin    B.    Nisin
    C.    Tylosin    D.    b-lactam antibiotic
Ans.    D.
3.    Which of the following bacteria is susceptible to thiophen-2-carboxylic acid hydrazide?
    A.    M. bovis    B.    M. tuberculosis
    C.    M. chelonei    D.    M. fortuitum
Ans.    A.

Introduction
A study protocol tool is a very important comprehensive document that deliberately outlines the whole research rationale design and plan for the successful execution of the epidemiological/ an experimental/ a clinical study. It serves as a blueprint for how the study will be conducted, ensuring consistency, transparency, and adherence to ethical guidelines. The document contains the background information available in literatures on the basis of which the researchers plan to conduct the study with objectives that will answer research related questions with ensuring adherence to ethical standards.
Basic Elements of a Study Protocol
The study protocol includes different components including background Information available in literature for research plan, objectives or purpose of conducting the research, explanation of the study design, selection and exclusion of subjects, treatment of subjects, assessment of outcome safety and efficacy. The purpose of conducting research includes questions like why the study needs to be done and what will be its relevance to scientific society or environment. To achieve these objectives the researchers, design their research work for proper execution of research objectives. The study which is to be designed has structured framework for researchers to answer their research questions and obtain reliable and valid results. The study design not only helps the researcher in learning technical skills but also discovering the creative voice (planning and execution). The study design includes different methods, processes and necessary resources for accomplishment of research problems. The study design also incorporates the methods of data collection and statistical analysis which meets the requirements of desired outcome. The implementation of an appropriate study design guarantees a methodical and exacting research process, resulting in more precise findings and the appropriate type of analysis to address the research-related queries. This makes the conclusions more reliable and legitimate. By ensuring that the data are reliable, repeatable, and validated, a well-designed study contributes to the advancement of knowledge. Additionally, it helps to control biases and confounding variables that could affect the results and helps to clarify the methodology of the study, which

A variety of glassware like burettes, pipettes, measuring cylinders, flasks, separating funnel etc. are used for experimental purposes in a laboratory. All of these need to be used and handled correctly, otherwise the chances of experimental error and damage to the glassware increase significantly. Being made of glass, they need special care while washing and using in experiments because even a minor mistake in handling of glassware may result in breakage of the apparatus. With this precautionary note, let us discuss about some of the specific glassware used in the laboratories.

Burette

Burette is a long graduated glass tube with a stopcock at one end for delivering a known/desired volume of a liquid, especially in titration experiments. It contains a stopcock at the lower end and a tapered capillary tube as the stopcock’s outlet. The flow rate of liquid from the tub stopcock’s outlet can be controlled with the help of stopcock valve. Burette is used for measuring the volume of a solution/chemical added in a quantitative (titrimetric) estimation experiment.

Procedure of using a Burette

The burette reading must be noted before and after delivering the chemical/ solution from the burette. The difference in these two readings is the volume of the chemical/solution released out of the burette. The solution should be released slowly/drop-by-drop to avoid any experimental error/mistake. If the solution/chemical is allowed to pour out too fast, the wall of the burette will not drain properly and some liquid may remain sticking to the surface of the walls. Moreover, excessive amount of chemical may be released/dropped during the experiment, particularly during the titration experiment wherein we need to know the exact amount of acid/base needed to get neutralization point. Thus, any minor mistake may lead to get a faulty reading. The measuring capacity of a burette usually used in a laboratory is 50 mL.

1. Introduction

Reactive oxygen species (ROS) is a collective term used for oxygen containing free radicals, depending on their reactivity and oxidizing ability. They participate in a variety of chemical reactions with biomolecule (Kunwar et al.,2011).These free radicals include superoxide anions (O2-), hydroxyl (OH-), peroxyl (ROO), peroxynitrite (ONOO) and nitric oxide (NO) radicals; produced through oxidative process within the body. They can damage both the structure and function of a cell membrane in a chain reaction leading to degenerative disease conditions such as alzheimer, ageing process, cataracts, acute liver toxicity, cardiovascular disease, arteriosclerosis, nephritis, diabetes mellitus, rheumatism, inflammation process and DNA damage that can lead to carcinogenesis (Ghosh et al., 2011).

An antioxidant is a molecule capable of inhibiting or preventing the oxidation of molecules. Antioxidants are substances that may protect cells from the damaging effects of oxygen radicals, highly reactive chemicals that play a part in atherosclerosis, some forms of cancer and reperfusion injuries. Medicinal plants are an important source of antioxidants. The secondary metabolites like phenolics and flavonoids from plants have been reported to be potent free radical scavengers. They are found in all parts of plants such as leaves, fruits, seeds, roots and bark (Chanda and Dave, 2009).

1. Introduction

Buckwheat is one of the most important life supporting nutritious crops, which has come as a secondary crop in many countries and has now attained its position in the agriculture of many countries where cereals form the stable food for the people. Though the crop is not a cereal, the seeds themselves can bring the name ‘pseudocereal’ due to their similar usage as cereal grains. There are many species of buckwheat in the world, of which mainly nine species have agricultural value (Krkoskova and Mrazova, 2005). Generally, the genus Fagopyrum in the family Polygonaceae includes two buckwheat species used for food around the world: common buckwheat (F. esculentum Moench), which is almost grown on all continents, and tartary buckwheat (F. tataricum (L.) Gaertn), which originated in eastern Tibet or northwestern Yunnan in China and is grown only in Asia, Europe, and North America (Bonafaccia et al., 2003; Tsuji and Ohnishi, 2001).

Buckwheat is grown throughout a large area as a crop that fits the farming system on marginal and fairly unproductive land. It is used as a subsistence crop in many of the more mountainous areas where it is often grown with barley at the higher altitudes. Tartary buckwheat, because of its frost tolerance, is generally grown at the higher altitudes whereas common buckwheat is grown at the lower altitudes. In many areas the trend is for replacement of common buckwheat, which has lower yielding ability and lacks frost tolerance, with finger millet or other crops.

Introduction
The safety of meat and its derivatives is a paramount concern in the dynamic realm of food trade. Consumers demand food products that are not only affordable and possess an extended shelf life but are also of high safety standards. Consequently, meat inspections require strict adherence to good manufacturing practices and safety labelling that aligns with regulatory standards. Food-borne pathogens, including Listeria monocytogenes, Staphylococcus aureus, pathogenic Escherichia coli, Clostridium perfringens, Campylobacter spp., and Vibrio spp., are responsible for numerous illnesses, thereby exerting a significant impact on public health and the economy. According to the World Health Organization (WHO), food contaminated with pathogens, chemicals, and allergens results in 600 million cases of food-borne illnesses and approximately 400,000 deaths globally each year. Furthermore, 56 million individuals die annually, with about 7.7% of the global population affected by foodborne diseases. Meat and meat products are essential sources of nutrients for humans, providing high-quality protein, essential amino acids, B vitamins, and minerals. However, due to their high-water activity and nutrient content, they also create a conducive environment for spoilage microorganisms and food-borne pathogens. Until a few decades ago, the meat industry was largely dominated by the unorganized sector, with limited access to knowledge that could enhance productivity. However, in the post-World Trade Organization (WTO) era, meat entrepreneurs have succeeded in increasing productivity, although they have faced challenges in ensuring product quality that aligns with the legislative standards of numerous developed and developing countries. The use of antibiotics as antimicrobial growth promoters in animal food production has been a contentious issue, as their unauthorized application has inadvertently contributed to the emergence of antibiotic-resistant bacteria within the food chain. Recently, the United States Trade Representative’s office estimated that international trade has expanded significantly since the General Agreement on Tariffs and Trade (GATT) was signed in 1947. The establishment of the WTO in 1995 further facilitated trade in animal-origin foods and live animals between nations. However, the emergence and re-emergence of diseases caused by pathogenic bacteria have become a significant concern in this new pattern of food trade. Some of these pathogens are so virulent that they were not previously reported. According to a 1998 report by the Centers for Disease Control and Prevention (CDC), the annual cost of foodborne illnesses in the United States is nearly 10 billion US dollars. The bacterial pathogens most commonly associated with illnesses from beef products include Salmonella spp., Clostridium perfringens, and Staphylococcus aureus. Interest in Escherichia coli O157: H7 increased following a highly publicized food poisoning outbreak linked to undercooked beef patties in the United States in 1993, although it was largely confined to North America until the mid-1990s. Similarly, multidrug-resistant Salmonella typhimurium DT-104 has spread widely since it was first identified in the United Kingdom. In India, the incidence of Salmonella in red meat was recorded at up to 9%. These potentially harmful bacterial pathogens can reside on the hides or in the intestinal tracts of foodproducing animals or may originate indirectly through cross-contamination or the processing environment. Other emerging foodborne diseases include Listeriosis, which has spread throughout France and Canada, where meat and meat products have been implicated as sources of Listeria monocytogenes. Similarly, Staphylococcal food poisoning or food intoxication syndrome, first reported in 1894, has become a global issue in the meat industry.

Contrary to “Law of Finite Biology” though the number of genetic codes will exhaust soon in an exponential way (presumably leading to solutions to every known genetic anomaly related health problem), the number of NCE (New Chemical Entity), their number being finite⁹⁹ too, will run out of fuel soon too, despite unraveling of genomic decoding. The bleak scenario in the pharmaceutical field is a testimony to the latter surmise. As many a wise scholar has pointed out, the era of single molecule drug seem to drawing curtains. However, unlike what seems common sense, the era of combinational drug therapies of MM paradigm probably will not foot the bill. Just as very high speed serial computing simulates parallel processing but does not make real time parallel processing, mixtures of prima facie complementary medicinal molecules will perhaps not make combinational recipes. The fundamentals of non-linear dynamical complex systems (NLDCS) paradigm demand so. The odds against success with such efforts are close to odds of success of creating life one bit at a time out of mixing C, H and O molecules in a jar would be. The number of genes might be finite, but data on their combinations (and their corresponding effects) and more so on their permutations (one has to only imagine the vastness of those possibilities) would, as of now or in near future, cause an information overload and comprehension failure¹⁰⁰ (limitation of human biological brain apparatus) pitting researchers and industry against a futility barrier. However, TM provides a silver lining to these bleak analyses. Analytical comprehension of TM recipes, regimens or techniques might be unachievable by contemporary science, empirical testing of their efficacy and safety being doable and therefore taken care of, TM can provide an outlet to the drug discovery impasse because the same natural forces that shaped multi-gene interaction into complex and dynamical mode have created some of, if not all, TM solutions.

Typically herbal pharmaceutics may include any medicinal or functional food preparations such as phytopharmaceuticals, single or poly herbal formulations, and nutraceuticals made out of botanical materials. This includes two broad categories. First, there are many evidence based formulations and mixures that may or may not be based on traditional knowledge or practices. The second group includes all the traditional or ethnopharmacological preparations. Bringing herbal medications from either group to the market will require a pharmaceutics approach balanced with an understanding of the original context in which the treatment was used.

As an example, Ayurvedic medicines have been used safely for many years on a wide variety of patients. Medications that have not been altered from their original form have de facto gone through a type of safety testing. When a traditional medicine is prepared differently, then it is essential to validate the drug safety to be sure that the effects of the new procedure don’t cause harmful effects. In this same way, the value of animal testing to establish safety and toxicity is not as critical if the botanicals are used in traditional forms. Suitable animal models help in understanding the mechanism of action or pharmacodynamics of medicines. However, it is well known that no good animal models exist for many human diseases, such as asthma, diabetes, and rheumatism. The use of modern technology in making traditional preparations more contemporary and scientific is important but it should not compromise the original basis and principles described in tracditional medicine. The following examples highlight some of the concerns of this approach.

The main purpose of herbal drug technology is to convert botanical materials into medicines with a focus on standardization and quality control with proper integration of modern scientific techniques and traditional knowledge. The use of chromatographic techniques and marker compounds to standardize botanical preparations has limitations because of their variable sources and chemical complexity. DNA-based molecular markers have utility in fields like taxonomy, physiology, embryology, genetics etc. DNA based techniques have widely been used for authentication of plant species of medicinal importance. Pharmacognosy mainly addresses the quality related issues using routine botanical and organoleptic parameters of crude drugs, and chemoprofiling assisted characterization with chromatographic and spectroscopic techniques. The new pharmacognosy includes all the aspects of drug development and discovery where the biotechnology driven applications play an important role. Current focus on chemotype-driven fingerprinting and related techniques require integration with genotype-driven molecular techniques so that an optimal characterization of botanical materials is possible. This review provides a brief account of various DNA based technologies that are useful in genotyping and quick identification of botanicals with suitable examples.

8.1. Classification

The ruminants belong to the Order Artiodactyla. The families in order of Artiodactyla include Camelidae, Tragulidae, Cervidae, Giraffidae, Antliocapridae, and Bovidae.

The family Camelidae includesGuanaco (Lama guanicoe), Llama (Lama glama), Alpaca or South American camelid mammal (Lama pacos), Dromedary camel (Camelus dromedarius), and Bactrian or two-humped camels (Camelus bactrianus).

The family Tragulidae includes Chevrotains originate from Africa (Hyumo schusaquaticus) and Chevrotains that originate from Asia (Tragulus species).

The family CervidaeincludesWhite tailed deer(Odococlius virginianus), Follow deer (Dama dama), Roe-deer (Capreolus capreolus), Axis deer (Axis axis), Reindeer (Rangiter tarandus), Musk deer (Moschus species) and Chinese water deer (Hydropotes species).

9.1. Classification: Order Perissodactyla

The order Perissodactyla, also known as odd-toed ungulates, is a group of herbivorous mammals characterized by having one or three toes on each foot. They are distinguished from even-toed ungulates (Artiodactyla) by this anatomical feature. Even-toed ungulates, such as pigs, cows, and deer, have an even number of toes (two or four) on each foot. Some of the well-known members of this order include horses, zebras, asses, tapirs, and rhinoceroses.

The name “Perissodactyla” comes from the Greek words “perissos,” meaning “odd,” and “daktylos,” meaning “finger or toe,” referring to their unique foot structure. Unlike even-toed ungulates (Artiodactyla), which bear weight on their third and fourth toes, perissodactyls primarily bear weight on their third toe.

Appendix - 1

Differential Diagnosis of Poisons based on Clinical Signs

Introduction

In the 1997 WHO guidance document: “WHO/VSQ/97.01: (A WHO guide to good manufacturing practice (GMP) requirements. Part 1: Standard operating procedures and master formulae)” some basic explanations and instructions were given for preparing various documents required by Good Manufacturing Practice guidelines from WHO and from several regulatory authorities.

GMP guidelines include the requirements for documents (individual), documentation (the systems and formats for documents), and documenting (recording) of production and control activities. Most GMP guidelines provide the same or very similar information as the principles of Good Manufacturing Practice are now international in scope.

In this guidance document, the requirement for master manufacturing instructions and the requirements as given in different GMP documents, different names for these documents and various forms that they can take will be described. This is to guide vaccine manufacturers who are applying for pre-qualification or re-qualification of their product(s) in the preparation or improvement of current documents for manufacturing operations.