{"id":9369,"date":"2012-06-10T00:44:14","date_gmt":"2012-06-10T00:44:14","guid":{"rendered":"http:\/\/www.homeobook.com\/?p=9369"},"modified":"2021-08-14T01:02:38","modified_gmt":"2021-08-14T01:02:38","slug":"quality-control-in-homeopathic-research","status":"publish","type":"post","link":"https:\/\/www.homeobook.com\/quality-control-in-homeopathic-research\/","title":{"rendered":"Quality Control in Homeopathic Research"},"content":{"rendered":"<p style=\"text-align: justify;\" align=\"center\"><strong>Dr Asha.K<\/strong>\u00a0 MD(Hom) Pharmacy<br \/>\nEmail : <a href=\"mailto:ashabelya123@yahoo.co.in\">ashabelya123@yahoo.co.in<\/a><\/p>\n<p style=\"text-align: justify;\">INTRODUCTION \u00a0<strong><br \/>\n<\/strong><strong>A. standard<br \/>\n<\/strong>The acceptability of any material in always established by prescribing a standard. It is a numerical value which \u201c<strong>Quantify<\/strong>\u201d a parameter and thus denotes the \u201c<strong>Quality<\/strong>\u201d and purity of material, thereby enhancing its \u201c<strong>Efficacy<\/strong>\u201d.<\/p>\n<p style=\"text-align: justify;\"><strong>Any Standard Product <\/strong>Definitely possess certain amount of stability or shelf life.<\/p>\n<p style=\"text-align: justify;\"><strong>Stability of a pharmaceutical product <\/strong>is defined as the capability of a particular formulation is a specific container to remain within its<\/p>\n<ul>\n<li>Physical<\/li>\n<li>Chemical<\/li>\n<li>Microbiological<\/li>\n<li>Therapeutic<\/li>\n<li>Toxicological&#8212; specifications for a prescribed period.<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">The concepts of standardization in the current day practice is emphasized mainly due to the Industrialization of Homoeopathic pharmaceutics so as to meet the global needs and standard for uniformity in procedures, quality, quantification.<\/p>\n<p style=\"text-align: justify;\"><strong>Stability<br \/>\n<\/strong>It is defined as the extent to which a product retains, within specified limits and throughout its period of storage and use. (its shelf life) the same properties and characteristics that is possessed at the time of its manufacture.<\/p>\n<p style=\"text-align: justify;\">The <strong>5 types of stability<\/strong> are<\/p>\n<p style=\"text-align: justify;\"><strong><span style=\"text-decoration: underline;\">Physical<\/span><\/strong>\u00a0\u00a0\u00a0 &#8211;\u00a0\u00a0 The original physical properties including<\/p>\n<ul>\n<li>\u00a0Appearance<\/li>\n<li>Palatability<\/li>\n<li>Uniformity<\/li>\n<li>Dissolution<\/li>\n<li>Suspend ability are maintained\u00a0<span style=\"text-align: justify;\">\u00a0<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><strong><span style=\"text-decoration: underline;\">Chemical<\/span><\/strong>\u00a0 &#8211;\u00a0\u00a0Each chemical \u201cIngredient\u201d retains its chemical\u00a0 integrity and labeled potency within the specified limits -Uninfluenced by storage conditions<\/p>\n<ul>\n<li>Temp<\/li>\n<li>Light<\/li>\n<li>Humidity<span style=\"text-align: justify;\">\u00a0<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><strong><span style=\"text-decoration: underline;\">Microbiological<\/span><\/strong> &#8211; \u00a0Resistance to microbial growth is retained according to specified requirements.<\/p>\n<p style=\"text-align: justify;\"><strong><span style=\"text-decoration: underline;\">Therapeutic\u00a0 &#8211;<\/span><\/strong>Therapeutic effect remains unchanged<\/p>\n<p style=\"text-align: justify;\"><strong><span style=\"text-decoration: underline;\">Toxicological <\/span><\/strong>\u00a0\u00a0\u00a0 &#8211; \u00a0 No significant increase in Toxicity<\/p>\n<p style=\"text-align: justify;\"><strong><span style=\"text-decoration: underline;\">Chemical stability<\/span><\/strong> is very important.<\/p>\n<p style=\"text-align: justify;\">They may be influenced by <strong><span style=\"text-decoration: underline;\">Storage conditions <\/span><\/strong><\/p>\n<ul>\n<li>Temp<\/li>\n<li>Light<\/li>\n<li>Humidity<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">Selection of proper <strong><span style=\"text-decoration: underline;\">CONTAINERS<\/span><\/strong> for \u2018dispensing\u2019<\/p>\n<p style=\"text-align: justify;\">(ex) glass vs plastic<\/p>\n<p style=\"text-align: justify;\">clear vs amber, opaque cap\u00a0 liners<\/p>\n<p style=\"text-align: justify;\"><strong><span style=\"text-decoration: underline;\">Stability \/ Shelf life \/ Expiry dating<\/span><\/strong> is based on \u201cReaction Kinetics\u201d.<\/p>\n<p style=\"text-align: justify;\">The <strong><span style=\"text-decoration: underline;\">study of rate of chemical change<\/span><\/strong> is infuenced by conditions of Concentration of reactants<\/p>\n<p style=\"text-align: justify;\">Products<br \/>\nOther chemical species that may be present<\/p>\n<p style=\"text-align: justify;\">By factors such as<\/p>\n<ul>\n<li>Solvent<\/li>\n<li>Pressure<\/li>\n<li>Temperature<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">The pioneers of R &amp; D wings and Research Institutes are entrusted is STANDARDIZATION works<\/p>\n<p style=\"text-align: justify;\"><strong>Aim<br \/>\n<\/strong>The ultimate aim of standardization is to produce\u00a0 Homoeopathy\u00a0 drugs that are<\/p>\n<ul>\n<li>Highly efficacious<\/li>\n<li>Quality<\/li>\n<li>Safety\u00a0<span style=\"text-align: justify;\">\u00a0<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><strong>QUALITY MONITORING APEX BODY<br \/>\n<\/strong>The <strong><span style=\"text-decoration: underline;\">Homeopathic Pharmacopoeia\u00a0 Laboratory (HPL)<\/span><\/strong> (1975) under the ministry of <strong>Health and Family Welfare, Government of India.\u00a0<\/strong>HPL, Ghaziabad<\/p>\n<ul>\n<li>Set up Sept 1975<\/li>\n<li>As a Plan Scheme under 5<sup>th<\/sup> Plan (1975-80)<\/li>\n<li>Subordinate institute of department of ISM &amp; Homeopathy, GOI<\/li>\n<li>Recognized by Dept of Science &amp; Technology, GOI as <span style=\"text-decoration: underline;\">Scientific, Technological and Research Institution<\/span><\/li>\n<li>Recognized as <span style=\"text-decoration: underline;\">Central Drugs Laboratory<\/span> \u2013 for testing of Homeopathic drugs (under <span style=\"text-decoration: underline;\">Rule 3A<\/span>, under <span style=\"text-decoration: underline;\">section-6<\/span> of D &amp;C Act)<\/li>\n<li>Functioning as STANDARD setting \u2013cum-drug testing laboratory at National level<span style=\"text-align: justify;\">\u00a0<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><strong>Legislation<br \/>\n<\/strong>Standards of Homeopathic drugs are covered under<\/p>\n<p style=\"text-align: justify;\">Second schedule of Drugs &amp; Cosmetics Act, 1940 [D&amp;C Act]\u00a0 \u00a0 \u00a0(Homeopathic medicines are defined <strong><span style=\"text-decoration: underline;\">in RULE 2\u00a0 (dd))<\/span><\/strong><\/p>\n<p style=\"text-align: justify;\">Under <strong><span style=\"text-decoration: underline;\">item 4A<\/span><\/strong> of the second schedule, under <strong><span style=\"text-decoration: underline;\">section 8 and 16<\/span><\/strong> of D&amp;C Act, 1940.<\/p>\n<p style=\"text-align: justify;\">Standards included in HPI, which include information on <strong><span style=\"text-decoration: underline;\">Characterization \/ Identification \/ Testing of Standards and Preparation of Homoeopathic medicines.<\/span><\/strong><\/p>\n<p style=\"text-align: justify;\">Statutory requirements to be followed by all the manufacturers of drugs for maintenance of quality of Homoeopathic drugs.<\/p>\n<p style=\"text-align: justify;\"><strong>HPI<br \/>\n<\/strong>Standards as worked out by laboratory are approved by Homeopathic pharmacopoeia committee\u00a0 (sept 1982) are published in the form of\u00a0 <strong><span style=\"text-decoration: underline;\">Homeopathic Pharmacopoeia India (HPI)<\/span><\/strong><\/p>\n<div style=\"text-align: justify;\" align=\"center\">\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td width=\"122\"><strong>Volumes<\/strong><\/td>\n<td width=\"189\"><strong>Year of Publication<\/strong><\/td>\n<td width=\"189\"><strong>Monographs<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"122\">1<\/td>\n<td width=\"189\">1971<\/td>\n<td width=\"189\">180 drugs<\/td>\n<\/tr>\n<tr>\n<td width=\"122\">2<\/td>\n<td width=\"189\">1974<\/td>\n<td width=\"189\">100 drugs<\/td>\n<\/tr>\n<tr>\n<td width=\"122\">3<\/td>\n<td width=\"189\">1987<\/td>\n<td width=\"189\">105 drugs<\/td>\n<\/tr>\n<tr>\n<td width=\"122\">4<\/td>\n<td width=\"189\">1984<\/td>\n<td width=\"189\">107 drugs<\/td>\n<\/tr>\n<tr>\n<td width=\"122\">5<\/td>\n<td width=\"189\">1986<\/td>\n<td width=\"189\">114 drugs<\/td>\n<\/tr>\n<tr>\n<td width=\"122\">6<\/td>\n<td width=\"189\">1990<\/td>\n<td width=\"189\">104 drugs<\/td>\n<\/tr>\n<tr>\n<td width=\"122\">7<\/td>\n<td width=\"189\">1999<\/td>\n<td width=\"189\">105 drugs<\/td>\n<\/tr>\n<tr>\n<td width=\"122\">8<\/td>\n<td width=\"189\">2000<\/td>\n<td width=\"189\">101 drugs<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p style=\"text-align: justify;\">Total number of monographs in HPI \u2013 916<\/p>\n<p style=\"text-align: justify;\">HPI indicates in the monograph of each drug<\/p>\n<ul>\n<li>Details for identification<\/li>\n<li>Details for collection<\/li>\n<li>Parts to be used<\/li>\n<li>Method of preparation<\/li>\n<li>Assessment of purity<\/li>\n<li>Limits of impurity<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">It is essential that these instructions be strictly followed to obtain mother tinctures of desired standards.<\/p>\n<p style=\"text-align: justify;\">Quality control is total procedure for providing the standard medicines to the patients.<\/p>\n<p style=\"text-align: justify;\">QC is not only a laboratory procedures, but also the procedures through which a raw material is transformed to a drug and the finished product till it is used by the patient.<\/p>\n<p style=\"text-align: justify;\">One of important function is to establish specifications for raw materials, packing materials, intermediates and finished products to assure the quality.<\/p>\n<p style=\"text-align: justify;\">For the sake of convenience, Quality Control in Homeopathic medicines is discussed, under 3 headings as<\/p>\n<ul>\n<li><strong>Quality control<\/strong><\/li>\n<li><strong>Raw materials &amp; vehicles<\/strong><\/li>\n<li><strong>Processing methods\u00a0\u00a0\u00a0\u00a0 or\u00a0 \u201cIn Process\u201d quality control<\/strong><\/li>\n<li><strong>Finished products<\/strong><\/li>\n<\/ul>\n<p style=\"text-align: justify;\">Care should be taken right from the sampling of raw materials\u00ae, identification of adulterants, \u00ae comparison with standards and analysed, \u00aetesting of purity, \u00ae manufacturing, \u00aeprocessing\u00ae different methods of preparation, \u00ae utensils, \u00ae machinery, \u00ae manufacturing area, \u00ae workers hygiene and safety, \u00aemonitoring industrial waste, \u00ae analysis of finished products, \u00ae manufacturing area, \u00ae workers hygiene and safety, \u00aemonitoring industrial waste, \u00ae analysis of finished products,\u00a0 packaging, \u00ae storing, \u00ae manufacturing area, \u00ae workers hygiene and safety, \u00aemonitoring industrial waste, \u00ae analysis of finished products,\u00a0 \u00ae manufacturing area, \u00ae workers hygiene and safety, \u00aemonitoring industrial waste, \u00ae analysis of finished products, \u00ae manufacturing area, \u00ae workers hygiene and safety, \u00aemonitoring industrial waste, \u00ae analysis of finished products, , \u00ae dispensing, , \u00ae handling and packaging of medicines while dispensing, the shelf in the physicians clinic\u00a0 \u00ae the patients methods of usage of medicines provided the shelf in the physicians clinic \u00ae \u00ae \u00ae in the patients wardrobe till the patients consume the medicine.<\/p>\n<p style=\"text-align: justify;\">In all these circumstances the quantity of products may decrease at any point along this long way. So to avoid these problems <strong><span style=\"text-decoration: underline;\">STANDARD OPERATING PROCEDURES\u00a0 (S.O.P)<\/span><\/strong> are to be written and maintained all along the way from the raw materials to Patients room.<\/p>\n<p style=\"text-align: justify;\">For ensuring that no substandard drugs are released to the Market<\/p>\n<p style=\"text-align: justify;\"><strong><span style=\"text-decoration: underline;\">C.G.M.P \u2013 Current Good Manufacturing Practice<\/span><\/strong> is adopted in the manufacturing, they are written procedures for manufacturing operations and document is manufacturing area. Also<\/p>\n<p style=\"text-align: justify;\"><strong><span style=\"text-decoration: underline;\">C.G.L.P \u2013 Current Good Laboratory Practices<\/span><\/strong> are adopted in the analytical laboratory. These are written procedures for analysis and documentation is analytical laboratory.\u00a0(What is not recorded is not done)\u00a0<strong>\u00a0<\/strong><\/p>\n<p style=\"text-align: justify;\"><strong>Raw materials\u00a0 <\/strong><\/p>\n<p style=\"text-align: justify;\">The quality of raw materials are ascertained and standardized referring HPI.<\/p>\n<p style=\"text-align: justify;\">The important raw materials used for manufacturing are<\/p>\n<ul>\n<li>Alcohol<\/li>\n<li>Lactose<\/li>\n<li>Sugar<\/li>\n<li>White petroleum jelly<\/li>\n<li>Maize starch<\/li>\n<li>Coconut oil<\/li>\n<li>Wax<\/li>\n<li>Minerals<\/li>\n<li>Herbs and animals etc<span style=\"text-align: justify;\">\u00a0<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><strong>In process quality control<br \/>\n<\/strong><\/p>\n<ul>\n<li><span style=\"text-align: justify;\">Embraces \u2018<\/span><strong style=\"text-align: justify;\"><span style=\"text-decoration: underline;\">every step of the preparation\u2019<\/span><\/strong><span style=\"text-align: justify;\"> from raw materials to finished product.<\/span><\/li>\n<li>It is critical in ensuring the purity and safety of homeopathic medicines.<\/li>\n<li>It is mandatory for the manufacturers to have GMP certificate and to follow their guidelines in order to produce quality drugs.<span style=\"text-align: justify;\">\u00a0<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\">GMP has two parts<\/p>\n<p style=\"text-align: justify;\">Part \u2013 I &#8211; \u00a0Lays down GMP guidelines<\/p>\n<p style=\"text-align: justify;\">Part \u2013II &#8211; \u00a0Lays down the machinery, equipment, details about minimum manufacturing premises required for various system of medicines<\/p>\n<p style=\"text-align: justify;\"><strong>Schedule M \u2013I, Rule 85-E(2)\u00a0\u00a0\u00a0 <\/strong><\/p>\n<p style=\"text-align: justify;\">This <strong><span style=\"text-decoration: underline;\">schedule M-I, rule 85 \u2013 E(2) <\/span><\/strong>States Good Manufacturing Practices (GMP) and requirements of premises, plants and equipment for manufacture of Homeopathic preparations.<\/p>\n<p style=\"text-align: justify;\">GMP guidelines are designed for the drug manufacturing units to ensure quality, efficacy and safety of their products for the benefit of the consumers.<\/p>\n<p style=\"text-align: justify;\"><strong>Standardization of finished goods<br \/>\n<\/strong>Includes (1) mother tinctures, (2) potentised dilutions, (3) Biochemic tablets, (4) triturations (powder), (5) ointments, (6) Oils, (7) Globules, (8) Eye drops, (9) Ear drops.<\/p>\n<p style=\"text-align: justify;\"><strong>CONCLUSION<br \/>\n<\/strong>The quality control procedures on raw materials governs the quality control of finished products and its procedures. So only a quality products is sold to market.<\/p>\n<p style=\"text-align: justify;\">For this reason QC of homeopathy medicine prime requisite in the modern developing world.<\/p>\n<p style=\"text-align: justify;\">Government should come forward with an<\/p>\n<p style=\"text-align: justify;\"><strong><span style=\"text-decoration: underline;\">EXPERT TEAM<\/span><\/strong> consisting of<\/p>\n<ul>\n<li>Institutionally trained practitioner<\/li>\n<li>Medical Research Experts from Various Medical Field<\/li>\n<li>Analytical chemist<\/li>\n<li>Biochemist<\/li>\n<li>Microbiologist<\/li>\n<li>Biotechnologists<\/li>\n<li>Pharmacologists<\/li>\n<li>Botanist<\/li>\n<li>Experts for handling equipments<\/li>\n<li>Expert for data management<\/li>\n<li>Pharmacovigilence etc.\u00a0\u00a0\u00a0\u00a0\u00a0 to evolve standardization works<\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><strong>In terms of modernization, industrialization aiming at mass production, great care and caution should be taken that these is no compromise on Hahnemanian Principles, as well as quality of our medicines.<\/strong><\/p>\n<p style=\"text-align: justify;\">This would be an\u00a0IDEAL WAY to promote efficacy, quality and safety of the homoepathy medicines and products<\/p>\n","protected":false},"excerpt":{"rendered":"<div class=\"mh-excerpt\"><p>Dr Asha.K\u00a0 MD(Hom) Pharmacy Email : ashabelya123@yahoo.co.in INTRODUCTION \u00a0 A. standard The acceptability of any material in always established by prescribing a standard. It is a numerical value which \u201cQuantify\u201d a parameter and thus denotes <a class=\"mh-excerpt-more\" href=\"https:\/\/www.homeobook.com\/quality-control-in-homeopathic-research\/\" title=\"Quality Control in Homeopathic Research\">[&#8230;]<\/a><\/p>\n<\/div>","protected":false},"author":1,"featured_media":42498,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[41],"tags":[2206],"class_list":{"0":"post-9369","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-research-homoeopathy","8":"tag-quality-control-in-homeopathic-research"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Quality Control in Homeopathic Research<\/title>\n<meta name=\"description\" content=\"In terms of modernization, industrialization aiming at mass production, great care and caution 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