STANDARD OPERTING PROCEDURE FOR COATING TABLETS

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STANDARD OPERATING PROCEDURES

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Standard Operating Procedure Coating Of Tablets P Nishanth Pharmaceutical analysis 1008-11-885-007 Osmania University SOP R X

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CONTENTS 1. Introduction 2. SOP preparation 3. General format of SOP 4. Sop for tablet coating 5. Conclusion 6. Bibliography 1

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" Standard Operating Procedure is a document which describes the regularly recurring operations relevant to the quality of the investigation”. SOP should be available at the place where the work is done 1.1. What is Standard O perating P rocedure? 1. INTRODUCTION 2

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1.2. Types Of SOP : 3

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C leaning Quality Assurance Validations Registration of samples P roduction Operating instrument Analytical methods Reagent preparation Safety precautions How to deal complaints Standard Operating Procedures Contd.. 4

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1.3. Purpose : Assist organization to maintain their quality control and quality assurance processes and ensure compliance with government regulations. The purpose of a SOP is to carry out the operations correctly and always in the same manner". 5

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minimizes variation and promotes quality through consistent implementation of a process. used as a part of a personnel training program minimizes opportunities for miscommunication and can address safety concerns. valuable for reconstructing project activities when no other references are available a valid SOP are reduced work effort, along with improved comparability, credibility, and legal defensibility 1.4. Benefit : 6

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S hould be written in a concise, step-by-step, easy-to-read format . Should provide all the information to perform a task. Information should be unambiguous S imple and short . follow the style guide used by your organization 1.5. Good standard operating procedure : 7

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Should use active voice and present verb tense Information should be conveyed clearly use of flow charts to illustrate the process Specific to the equipment used for the procedure. Should provide Quality Control information Should provide References Contd … 8

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2. SOP Preparation : Head of Laboratory Staff member ( author) SOP administrator (New Registration N umber) Prepares SOP one or more qualified colleagues (Perform task) SOP is submitted to the SOP administrator for acceptance Those SOPs should then be written by individuals knowledgeable with the activity and the organization's internal structure. 9

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3.1. General format of SOP : Procedure title Sop id no Date of issue Name of applicable agency Signature &dates TITLE PAGE quick reference locating information denote changes or revisions TABLE OF CONTENT purpose standards Scope Definitions procedures Personal qualification Safety precautions TEXT 10

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GUIDELINES FOR TECHNICAL AND FUNDAMENTAL SOP 11

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3.2. Lay out of sop : 12

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13

4. SOP FOR TABLET COATING:

4. SOP FOR TABLET COATING 14

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Tablet coating is a process where by tablets are coated with either cellulose based film or sugar coat. The coating is achieved by spraying a solution or suspension of the coating material onto the tablet in the form of fine droplets and at the same time pass a flow of heated air oven the tablets. The air flow dries off the solvent leaving the dissolved or suspended materials on the tablet as a coat 4.1. TABLET COATING 15

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4.3. Purpose of tablet coating : Protect the active ingredient from light or moisture Mechanically protect the tablet from breakage Mask the taste Protection from gastro intestinal fluids Control the release 16

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4.4. Coating equipment : Fluid bed system Perforated pan system Conventional pan system 17

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4.5. F ilm and Sugar coating pan maintenance sop 4.5.1.a PURPOSE 4.5.1.b. It is used for film and Sugar coating of tablets. 4.5.2.a SCOPE 4.5.2.b This is applicable for proper film and sugar coating in dry product manufacturing section. 4.5.3.a RESPONSIBILITY 4.5.3.b Maintenance officer (Mechanical / Electrical) 4.5.3.c Maintenance Supervisor (Mechanical / Electrical ) 18

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4.5.4. PROCEDURE The Coating Pan is handled in the following way. 4.5.4.b. MAINTENANCE 4.5.5.a MONITORING OF MACHINE MAINTENANCE: 4.5.5.b. Time to time check each and every part of Coating Pan according to the maintenance schedule . 4.5.5.c. Check the following parts carefully. Electric motor Electric Starter V , Belt Gear box Oil Level ( if required change it ) Bearing and Shaft 19

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4.5.5.d. This activity is then documented in the form Machinery & Equipment Maintenance Log 4.5.5.e. Check the Coating Pan condition time to time to find any kind of problem during operation . 4.5.5.f. All the monitoring record is filed and kept by the Maintenance Supervisor . 4.5.6.a. EMERGENCY / BREAKDOWN MONITORING: 4.5.6.b. Maintenance Manager receives Maintenance Work Order ) duly signed by the section in charge of the concerned machinery or equipment . 4.5.6.c. Maintenance Work Order () is assigned a number according to the receiving in the Maintenance Reference Register 4.5.6.d. Maintenance Manager assigns the maintenance work to the concerned personal 20

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4.5.6.d. After the completion of work the section in charge signs the completion of Work Order. 4.5.6.e. All the record is filed and kept by the Maintenance Supervisor. 4.5.7.a. PRECAUTION: 4.5.7.b. Always wear protective mask, gloves when working on coating pan. 21

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5. Conclusion : SOPs are frequently used as checklists by inspectors when auditing procedures as they minimize variation and promotes quality through consistent implementation of a process there by reducing work effort, along with improved comparability, credibility, and legal defensibility. 22

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6 . Bibliography : American Society for Testing and Materials. ASTM D 5172-91 (2004), Standard Guide for Documenting the Standard Operating Procedures Used for the Analysis of Water. 2004. American Society for Testing and Materials, West Conshohocken, PA. Code of Federal Regulations. July 1, 1999. 40 CFR Part 160. Good Laboratory Practice Standards. U.S. Environmental Protection Agency. 2001a. EPA Requirements for Quality Assurance Project Plans (QA/R-5), EPA/240/B-01/003, Office of Environmental Information, Washington 23

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Queries: 24

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T H A N K Y O U