Seth G.L. Bihani S.D. College of Technical Education

2 December 2012

IMPURITIES AN OVERVIEW

About Authors:
Lila dhar^*, Prof. Sanjeev Thacker, Jatin Patel
Seth G. L. Bihani S.D. College Of Technical Education, Institute Of Pharmaceutical Sciences & Drug Research,
Gaganpath, Sri Ganganagar, Rajasthan 335001
*ldbudania@gmail.com

ABSTRACT
Impurities is defined as an entity of drug substances or drug product that is not chemical entity defined as drug substances an excipients or other additives to drug product. In pharmaceutical world, an impurity is generally considered as an other organic material beside the other drug substances that is arises out of the synthesis most of the time, inorganic contaminants are not considered as an impurity unless they are toxic, such as heavy metal or arsenic. There are numerios source of impurities and many different common terms are use for impurities such as by product, intermediate, transformation on product, related product, interaction product and degradation products.
30 November 2012

Thermogravimetry

About Authors:
Jatin Patel^*
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Patelj313@yahoo.com

ABSTRACT:
Thermogravimetry is a branch of physical chemistry, materials research, and thermal analysis. It is based on continuous recording of mass changes of a sample of material, as a function of a combination of temperature with time, and additionally of pressure and gas composition.

It includes different types of Thermogravimetric analysis. In this article types, Instrumentation, Procedure, Application are priscribed.
30 November 2012

NEW DRUG APPROVAL PROCEDURE IN INDIA

About Authors:
Jatin Patel^*, Krunal Parikh, Dhiren Shah
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Patelj313@yahoo.com

ABSTRACT:
A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. In general, a drug approval process comprises of various stages: application to conduct clinical trials, conducting clinical trials, application to marketing authorization of drug and post-marketing studies. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs.
This article includes new drug approval process in different countries include India, Australia, European union, China etc.
New drug approval process in different countries are described in logarithmic representation.
28 November 2012

PHYSICAL STABILITY TESTING OF DRUGS AND DRUG PRODUCTS

About Authors:
L.D.Budania
Seth G. L. Bihani S. D. College Of Technical Education,
Institute Of Pharmaceutical Sciences & Drug Research, Gaganpath,
Sri Ganganagar, Rajasthan 335001
*ldbudania@gmail.com

ABSTRACT:
Stability is an essential quality attribute for drug products. If there is any functionally relevant quality attribute of a drug product that changes with time, this evaluation checked by pharmaceutical scientist and regulators who quantify drug product stability and shelf life. The rate at which drug products degrade varies dramatically. E.g. radiopharmaceutical products. Since the evaluation of the stability of drug is highly specialized and esoteric nature. Drug stability concerns about drug product safety, efficacy, and quality, found it to appropriate. Stability studies are done through the regulatory agencies such as FDA and HPB (health protection branch).
27 November 2012

MANUFACTURING DOCUMENTATION IN PHARMACEUTICAL INDUSTRY- DEVELOPMENT AND IMPLEMENTATION

About Authors:
Krunal Parikh^1*, Mr. Maheshkumar Kataria², Jatin Patel¹
²Assistant professor, Department of pharmaceutics,
¹Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Krunal_2922@yahoo.in

ABSTRACT
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized. It consequently strengthens the quality, and its consistency, of all goods and services, as those responsible for the specific operations have clear, unambiguous instructions to follow including active drug substances, is legally mandatory.

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19 November 2012

ESSENTIAL ELEMENTS OF PATENT

About Authors:
Jatin Patel^1*, Prof. Rajesh Kumar Dholpuria², Dhiren Shah¹
²(Professor, Head of Department of pharmacognosy),
¹Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Patelj313@yahoo.in

ABSTRACT
Patent Right varies from country to country. In India the law which govern patent right is "Indian Patent Act 1970". Indian Patent Act, 1970 grants exclusive right to the inventor for his invention for limited period of time. Generally 20 years time has been granted to the patent holder but in case of inventions relating to manufacturing of food or drugs or medicine it is for seven years from the date of patent. There is certain legal procedure which needs to be followed in order to register. There are several attorney helping inventor in patent registration by providing them best well informed knowledge. In India patent registration can be filed individually or jointly. In case of deceased inventor this can be done his legal representative on behalf of him. All the required documents need to be filed along with the application form. Only after verification registration certificate is provided to the applicant.
14 November 2012

PACKAGING AND LABELLING CONTROL ACCORDING TO GLOBAL GMP

About Authors:
*Tarun Patel, Prof. Dr. Vipin Kukkar, Krunal Parik
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*tarunpatel35@gmail.com

ABSTRACT:
In pharma industry Packaging and Labelling plays very important role for improvements of attraction to human beings. So by improving our packaging and labeling style we can easily improve our product market value. Green packaging is also an alternative to make packaging more environmental friendly which would not affect the nature in any way. The most desirable solution is “use less, discard less, save more, reuse more”In this review article we discuss briefly about the requirement of packaging and labeling control of product according to different GMPs.

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9 November 2012

EVALUATION OF CRUDE DRUGS, MONO OR POLYHERBAL FORMULATION

About Authors:
Dhiren Shah^*1, Jatin Patel, Krunal Parikh
m.pharmacy
Seth G.L. Bihani S.D. College of Technical Education, R.U.H.S.
Sri Ganganagar, Rajasthan, INDIA
*dhiren.pharmacist@gmail.com

Abstract :
Involved Evaluation and Standardization techniques for crude drugs, mono or Polyherbal Frormulation. They involved the macroscopic techniques, microscopic techniques, physical evaluation and biological evaluation. They also involved the Quantitative analysis of Organophosphorus insecticides, Organochlorine and pyrethroid insecticides, microbial content determination.
7 November 2012

APPLICATION OF LC-MS

About Authors:
Jatin Patel^1*, Prof. Rajesh Kumar Dholpuria², Dhiren Shah¹
²(Professor, Head of Department of pharmacognosy),
¹Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Patelj313@yahoo.com

ABSTRACT:
Liquid chromatography is a fundamental separation technique in the life sciences and related fields of chemistry. Unlike gas chromatography, which is unsuitable for nonvolatile and thermally fragile molecules, liquid chromatography can safely separate a very wide range of organic compounds, from small-molecule drug metabolites to peptides and proteins. Traditional detectors for liquid chromatography include refractive index, electrochemical, fluorescence, and ultraviolet-visible (UV-Vis) detectors. Some of these generate two- dimensional data; that is, data representing signal strength as a function of time. Others, including fluorescence and diode- array UV-Vis detectors, generate three-dimensional data. Three-dimensional data include not only signal strength but spectral data for each point in time. Mass spectrometers also generate three- dimensional data. In addition to signal strength, they generate mass spectral data that can provide valuable information about the molecular weight, structure, identity, quantity, and purity of a sample. Mass spectral data add specificity that increases confidence in the results of both qualitative and quantitative analyses. For most compounds, a mass spectrometer is more sensitive and far more specific than all other LC detectors. It can analyze compounds that lack a suitable chromophore. It can also identify components in unresolved chromatographic peaks, reducing the need for perfect chromatography. Mass spectral data complements data from other LC detectors. While two compounds may have similar UV spectra or similar mass spectra, it is uncommon for them to have both. The two orthogonal sets of data can be used to confidently identify, confirm, and quantify compounds.
4 November 2012

CONTRACT MANUFACTURING AND THEIR AUDITING

About Authors:
Arshad Hala*, Prof. Rajesh Dholpuria, Nilesh Sovasia
¹Seth G. L. Bihani S. D. College Of Technical Education,
Institute Of Pharmaceutical Sciences & Drug Research,
Gaganpath, Sri Ganganagar, Rajasthan 335001
*Arshad_hala@yahoo.com

1. INTRODUCTION:-
1.1. Origin:-
Contract manufacturing is defined as the manufacture (or partial manufacturer) of a product to the order of one person or organization (the contract giver or customer) by another independent person or organization (contract acceptor or principle manufacturer). Manufacture in this context is identified as the act of processing or packaging a medicinal product or device to a given specification.(Shah, D.H., 2000)

Contract manufacturing should be consideration as an extension of the principal manufacturer’s operation. Consequently the principal manufacturer should require the same standards of good manufacturing practices (GMP) for a contractor’s operation as he would his own. In addition, the customer must ensure that the principle manufacturer holds the relevant legal authorizations for the work to be carried out.(Shah, D.H., 2000)

The responsibility and activities undertaken by each party need to be clearly stated in a formal agreement, separate from but additional to the legal business contract formed by the placement of an order. Commercial matters need to be appreciated as being distinct from technical matter and need to be detailed separately with due consideration for compliance with local legislation.(Shah, D.H., 2000)