eChapters

6.1 Introduction

The state of India’s forests is important in many ways, whether it be as a source of fuel and fodder for rural citizens, of industrial inputs for a growing economy, as a habitat for thousands of plant and animal species, a sink for carbon dioxide emissions, or as a protective cover for its soils.

The forest resources forms an ecological system consisting of tree dominated vegetative associations. Forests not only provide timber, fuel wood, pulpwood fodder and fiber grasses, and non wood forest produce and support industrial and commercial activities but also maintain the ecological balance and life support systems essential for food production, health, and all round human development. The innate complexity and inherent diversity of forest ecosystems make it difficult to establish clear cause-and effect relationship or to predict the outcomes of a given intervention accurately. Figure 6.1 shows that the percentage of land mass with forest covered and non forest area in India

5.1 Introduction

The source of pollution are many and varied. The most critical are domestic sewage and industrial effluent discharging into rivers, lakes, ponds etc. Treatment facilities for domestic sewage in class 1 cities having population of more than 1,00,0000 and class 2 cities having population between 50,000 and 99,999 can process hardly 10% of the wastewater generated. Wastewater treatment facilities are difficult to quantify due to lack of continuous data. On an average, the treatment capacity in class 1 cities can handle only 60% of the wastewater collected and less than 15% of the total volume of wastewater generated.

The Indian industry has grown annually at an average rate of 5.5% during the last 50 years. Among different industrial sectors, water pollution is concentrated with in a few industrial sub-sectors mainly in the form of toxic wastes and organic pollutants. Out of the total pollution contributed by the industrial sub-sectors, 40% to 45% of the total pollutants can be traced to the processing of industrial chemicals and nearly 40% of the total organic pollution to the food products industry alone. Food products and agro-based industries together contribute 65% to 70% of the total industrial wastewater in terms of organic load. Blair T Bower, consultant, the Urban Institute, USA, remarks: "… If substantial further growth of Asia’s cities cannot be avoided and if the environmental disasters that could be associated with that growth are to be prevented, there is only one alternative: urban environmental quality management must be substantially improved throughout the region".

The total quantity of water used by the domestic and industrial sectors is much less than that consumed for irrigation. However, the wastewater released from the above sectors has a great concentration of pollutants, and is discharged at specific disposal points. Thus, the wastewater generated from domestic and industrial projects causes much more water pollution as compared to any other source.

4.1 Introduction

India is a land of many rivers, lakes, ponds, coastal, marines and mountains. Its geographical area of about 329 million hectare is crises crossed by a large number of small and medium, large rivers, some of them figuring amongst the mighty rivers of the world. The rivers and mountains have a greater significance in the history of Indian civilizations, development, religious and spiritual life. It may not be an exaggeration to say that the rivers are the heart and soul of the Indian civilizations

India is a union of States with a federal set up. Politically, the country is divided into 26 States and 7 Union Territories. A major part of India’s population of 869 millions (1991 census) is rural and agriculturally oriented for whom the rivers are the source of their life. India is a land of many religions, diversity of cultures and languages. The different regions of the country have different cultural, linguistic and other ethnic groups. The land and people present a vast panorama of diversity in unity. Physiographically, India may be divided into seven well-defined regions.

3.1 Introduction

India, when gained independence in 1947, was predominantly an agrarian economy, with a stagnant national income. The country inherited a weak industrial base, restricted to only a few industries. Agricultural growth was virtually negligible, the country had a stagnant cropped area where by only a very small proportion of agricultural land was irrigated. On the eve of the country’s independence, on 15^th August 1947, Jawaharlal Nehru, India’s Prime Minister, reminded the country that the task ahead included ending poverty, ignorance, and disease and inequality of opportunity. India began the process of planning with the launching of the 1^st five-year plan in April 1951. The central purpose of planning was to ‘initiate a process of development which would raise living standards and open out to the people new opportunities for a richer and more varied life’. Afterwards, the five-year plans were formulated seeking development in a sustainable manner.

The country, over the past has travelled a long way indeed in its drive towards economic growth, modernization of the economy, feudal economy at the time of independence has been transformed into one based on a fairly developed and diversified industrial structure and a sound agricultural base with a large potential for further industrialization and development. The income and consumption levels of people, on an average, have increased and the consumption basket has diversified. A noteworthy achievement indeed has been the elimination of famines with which the country continued to be afflicted right until independence. That achievement is far from negligible since many other countries in Asia and Africa are yet to free themselves of this malady. There is also other achievement, varying from the successful functioning of a democratic system to the emergence of a strong and large scientific community (Dreze Sen, 1995). The figure 3.1 shows the per capita income during 1997-1998. It shows that the maximum income from Northern India compared to Southern India. However, having adapted the pattern of economic development that brought prosperity to the Western, India has also seen widespread environmental damage and degradation in the pursuit of economic growth. The concern for preserving the environment against the onslaught of industrial expansion, intensification of agricultural, and adoption of a resource-intensive lifestyle has not been given the attention it deserved, and the costs of environmental degradation have not been internalized in the development process. While the Indian economy study made by two World Bank staffers shows that the country is paying an enormous price for this onward march, which has brought in its wake ecological devastation and numerous health problems.

The science is a process of refining our understanding of nature by continual questioning and active investigation on questions. Students can approach science in this manner, rather than as a collection of facts to be memorized. The Environment is to provide up-to-date information to the important concepts in the study of environment. Information is presented from an analytical, observation and multidisciplinary perspective from which we must view environmental issues in order to deal successfully with them. The environment may be defined as response of a human being influenced by various factors such as abiotic and biotic, which are present in the ecosystems.

2.1 Multidisciplinary Approach

The approach of environment science is multidisciplinary in nature like botany, zoology, physics, hydrology, hydraulics, chemistry, biophysics, biochemistry and biology. It integrates various subjects and includes few of the most important topics of modern civilization as well as oldest philosophical concerns. Applied and basic aspects of environment requires a solid function in the nature of our relationship with nature, in addition to fields like economics, anthropology, history, sociology and philosophy of the environment.

Water is an important element for life on the earth. It is an essential recurrent natural resource for environmental sustenance, agricultural productivity, industrial growth, power production, enrichment and renewal of land and air. For easy assess to the water, the first human settlements occurred along the banks of rivers and ensuing civilizations flourished in river valleys. For example, the Indian civilization of Mohanjodaro and Harappa developed in the Indus valley, the Egyptian civilization in the Nile valley, the Chinese civilization in the Yangtze valley, the Babylonian civilization between the Tigris and the Euphrates rivers, Aztec, Maya and Incas civilization in the basin of Amazon river.

The industrial revolution, which, began in the early 18th century in some European and Asian countries, set in the motion for new forces in the society and greatly changed the pattern of social life on the earth. Rapid industrialization and urbanization subsequently brought many changes in the environment and ecosystems in the world. India also witnessed a phenomenon of industrial development in the post independent era. The last four to five decades have witnessed population explosion and increase in the per capita consumption of food, consumer goods and utilization of natural resources. These have lead to the proportionate increase in the domestic and industrial effluent generation in India. The water pollution is continuously increasing at an alarming rate in Europe and Asia. By the end of this century. India's Population is projected to double itself from its present level. Similarly the per capita consumption of food has been estimated to increase by 40% resulting in 50 % production of industrial and domestic effluents in near future.

Apart from the quantity, there will be qualitative changes in the effluent generation which are likely to contain greater amount of oil, toxic chemicals, detergents and dyes. A large number of these compounds are non-biodegradable and are cumulative, thus rendering toxic product. Certain group of animals and plants are selective in their functions and can executive certain toxic chemicals and heavy metals. These biomes are helping more effectively on recycling of industrial effluent as well as domestic effluent management system.

In nature, there exists a balance between abiotic and biotic communities like animals and plants population, raw materials and total biomass present at any time. This balance ensures natural recycling and optimum production in naturally balanced ecosystems. The plant growth is slow, but it ensures optimum utilization of waste products and a healthy environment. The increased population and its human desire to possess all comforts and pleasures had lead to over exploitation of natural resources. The high demand of natural resources lead to the beginning of waste accumulation due to the creation of man made imbalances in the environment. The environment is to provide up to date information about important concepts in surrounding. Information is presented from an analytical, observational and multidisciplinary perspective from which we must view environmental issues in order to the study successfully.

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.

1 Introduction

The purpose of these Guidelines on Audit Quality is to assist Supreme Audit Institutions assure the high quality of their work and the resulting products. This Section describes the background of the document, provides key definitions applicable to these guidelines, discusses the types of SAIs and audits to which the guidelines apply, lays out the form in which the guidelines are presented and identifies some other sources of useful guidance for assuring quality. Section 2 then deals with quality control as the “hot review” ofthe audit process. Subsections 2.1 — 2.6 set forth some basic premises for establishing effective quality controls, discuss the nature of the controls required to assure quality in the areas of selection and timing of audits, planning specific audits, executing audits, reporting the results of audits, and following up on audits, respectively. Section 3 describes the procedures necessary to assure that needed quality controls are in place and operating effectively, that is it presents the characteristics of post-audit quality assurance. Finally, Section 4 focuses on institutional measures to enhance quality, especially management of human resources (recruitment, training, staff development and ethical standards), institutional risks and external relations. The Annexes provide other information that was considered potentially useful, including reference material, checklists and excerpts regarding quality controls from other guidance documents. The list of reference documents is contained in Annex A.

Audit quality is obtained by a process of identifying and administering the activities needed to achieve the quality objectives of an SAI. All types of SAI need to understand the benefits that can be realised once audit quality is made a priority. Improving audit quality requires a systematic SAI- wide approach. Piecemeal efforts by individuals and individual audit teams are not enough and will not work. There are no quick fixes to be obtained where audit quality is concerned. SAIs needs to proceed methodically in an organised way to fix each quality issue and problem in turn. As new problems will always emerge, this should be a continuous process for the SAI. It is also evident that most audit quality related problems are mainly the result ofpoor management of the audit process or the SAI itself.

Analytical methods development and validation play important roles in the discovery, development, and manufacture of pharmaceuticals.

Pharmaceutical products formulated with more than one drug, typically referred to as combination products, are intended to meet previously unmet patients need by combining the therapeutic effects of two or more drugs in one product. These combination products can present daunting challenges to the analytical chemist responsible for the development and validation of analytical methods. This presentation will discuss the development and validation of analytical method (Spectrophotometric, High performance liquid chromatography (HPLC), & High performance thin layer chromatography (HPTLC)) for drug products containing more than one active ingredient. The official test methods that result from these processes are used by quality control laboratories to ensure the identity, purity, potency, and performance of drug products.

This chapter focuses on the statistical methods used for method development. These are categories as follow :

1.SUPAC- Scale-Up and Post-Approval Changes

2.PAT -Process Analytical Technique

1. SUPAC - The acronym “ SUPAC “stands for “Scale-Up and Post- Approval Changes” . It refers to the FDA-recommended testing and filing actions to be taken by a pharmaceutical firm when it changes the manufacturing processes of a drug product that has been approved via a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), or an Abbreviated Antibiotic Drug Application (AADA). FDA has provided its recommendations to industry in the form of SUPAC Guidances or supac guidelines.

Validation in the pharmaceutical and medical device industry is defined as the documented act ofdemonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for Good Manufacturing Practices and other regulatory requirements. Since a wide variety ofprocedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:

Principle

Good documentation constitutes an essential part of the quality assurance system. Clearly written documentation prevents errors from spoken communication and permits tracing of batch history. Specifications, Manufacturing Formulae and instructions, procedures, and records must be free from errors and available in writing. The legibility of documents is of paramount importance.

General

Specifications describe in detail the requirements with which the products or materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation. Manufacturing Formulae, Processing and Packaging Instructions state all the starting materials used and lay down all processing and packaging operations.

Procedures give directions for performing certain operations e.g. cleaning, clothing, environmental control, sampling, testing, and equipment operations.

Records provide a history of each batch of product, including its distribution, and also of all other relevant circumstances pertinent for the quality of the final product.

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.

1. GMP

Good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products

To achieve the objectives listed below, each licensee shall evolve appropriate methodology, systems and procedures which shall be documented and maintained for inspection and reference; and the manufacturing premises shall be used exclusively for production of drugs and no other manufacturing activity shall be undertaken therein.

Environmental management systems (EMSs) such as ISO 14000 are seen as mechanisms for achieving improvements in environmental performance and for supporting the trade prospects of “clean” firms. The potential advantages of EMSs are clear, but the adoption of ISO 14000 is very recent, and practical issues are emerging, among them the need for an emphasis on performance improvement and for simplification of certification; the potential for regulatory streamlining; and the trade consequences. This chapter outlines the key elements of an EMS and discusses these issues.

The Benefits of an EMS

An environmental management system (EMS) is a structured program of continuous environmental improvement that follows procedures drawn from established business management practices. The concept is straightforward, and the principles can be easily applied, given the necessary support. There has been increasing interest in the potential value of EMS approaches, ofwhich the recently released ISO 14000 series is the most widely known.

The first steps in the control of industrial pollution have been the creation of the necessary regulatory framework and the specification and design of control equipment to reduce emissions. These efforts have been broadly successful in improving the performance of many polluters, but in other cases, investments in pollution equipment are wasted because the equipment is not operated properly. Attention, in the World Bank and elsewhere, is turning to support of regulatory and end-of-pipe approaches through incentives, production efficiencies, and management improvements a range of measures often grouped under the broad banner of cleaner production and eco-efficiency.

It 9001:2000 Means customer satisfaction and continuous improvement

ISO (International Organization for Standardization) is a worldwide federation of national Standards bodies from each country. The object of ISO is to promote the development of Standardization and related activities in the world with a view to facilitating international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity. The results of ISO technical work are published as International Standards.

Quality management Systems (QMS) certification as per ISO 9001 : 2000 is an important opportunity that can enable the companies acquire the label of an enterprise caring for the customer needs and improve their economic performance at the same time. QMS provides an organization a systematic structured documented and effective approach to consistently maintain the product quality meeting customer requirements.

TQM is an integrative philosophy of management for continuously improving the quality of products and processes. It is used around the world.

TQM functions on the premise that the quality of products and processes is the responsibility of everyone who is involved with the creation or consumption of the products or services offered by an organization. In other words, TQM capitalizes on the involvement of management, workforce, suppliers, and even customers, in order to meet or exceed customer expectations. Considering the practices of TQM as discussed in six empirical studies, Cua, McKone, and Schroeder (2001) identified the nine common TQM practices as cross-functional product design, process management, supplier quality management, customer involvement, information and feedback, committed leadership, strategic planning, cross-functional training, and employee involvement.

TQM and Six Sigma

The Six Sigma management strategy originated in 1986 from Motorola’s drive towards reducing defects by minimizing variation in processes. The main difference between TQM and Six Sigma is the approach Six Sigma is a business management strategy originally developed by Motorola, USA in 1986. As of 2010, it is widely used in many sectors of industry, although its use is not without controversy.

Accuracy

The degree of closeness of the determined value to the nominal or known true value under prescribed conditions. This is sometimes termed trueness.

Analyte

A specific chemical moiety being measured, which can be intact drug, bio molecule or its derivative, metabolite, and/or degradation product in a biologic matrix.

Analytical run (or batch)

A complete set of analytical and study samples with appropriate number of standards and QCs for their validation. Several runs (or batches) may be completed in one day, or one run (or batch) may take several days to complete.

Biological matrix

A discrete material of biological origin that can be sampled and processed in a reproducible manner. Examples are blood, serum, plasma, urine, faces, saliva, sputum, and various discrete tissues.

In the Radiochemical Laboratory

The following are some illustrative recommendation which may be used selected as a guide for setting up working rules :

General

No unnecessary materials should be brought into the laboratory. No unnecessary work should be done there.

Eating, drinking, and the use of cosmetics in the laboratory should be forbidden. Radioactive materials should not be place in milk bottles, soft drink bottles, or other vessels that might be inadvertently used for food purposes.

Record should be kept of radioactivity brought into the building and of its disposition.

Radionuclides are used in two major ways: for their chemical properties and as sources of radiation.

Radionuclides of familiar elements such as carbon can serve as tracers because they are chemically very similar to the non-radioactive nuclides, so most chemical, biological, and ecological processes treat them in a near identical way. One can then examine the result with a radiation detector, such as a Geiger counter, to determine where the provided atoms ended up. For example, one might culture plants in an environment in which the carbon dioxide contained radioactive carbon; then the parts of the plant that had laid down atmospheric carbon would be radioactive.

In medicine, radioisotopes are used for diagnosis, treatment, and research. Radioactive chemical tracers emitting gamma rays that can provide diagnostic information about a person’s internal anatomy and the functioning of specific organs. This is used in some forms of tomography single emission computed tomography and positron emission tomography scanning. Radioisotopes are also a promising method of treatment in hemopoietic forms of tumors, while the success for treatment of solid tumors has been limited so far. More powerful gamma sources are used to sterilize syringes and other medical equipment. About one in two people in Western countries are likely to experience the benefits of nuclear medicine in their lifetime.

In biochemistry and genetics, radionuclides are used to label molecules and allow tracing chemical and physiological processes occurring in living organisms, such as DNA replication or amino acid transport.