Macleods Centre of Ey Technical Tr: Title Good Manufacturing Practices (GMP) Document | MCE/TM/002-01 | Effective Date: No: Prepared by | Reviewed by _ | Approved by (coe) (COE) (CQA) Sign. & date ice/tHy002-01, ® aceods Contre of Excelence Macleods Centre of Excellence Technical Training 5 Good Manufacturing Practices (GMP) -Basic introduction mcesrmyoo2-01 @ Macleods Centre of Excellence 9/30/2024imino Good Manufacturing Practices Index What is (AP & Formal 1D What is drug 1 What is Quality 1 What is Quality standards 1 What is GMP? 1D Why GMP is Required? 2 1 Importance of GMP 0 10 Principles of GMP 0 Different International Authorities In The World 1 Personal hygiene cerruvoo2-ot @& Macleods Centre of Excellence Good Manufacturing Practices iin Active pharmaceutical ingredient ive ingredient means any component thai is intended to farnish Parmacolegicl activity or other diet effect in the diagnosis, cure Inkigtion, weatment or prevention of disease, or o affect the structure any funetion ofthe body of man or other animale Drug produet Drug prod Act shed dosage fo cn 2 form, for example, abl \ ete., that contains an active dr : : but not necessarily, in association with inact ingredient zenerally also include adients, The term does not contain an active be used as a placebo a Tinished dosage i stn save form th nuredient but is intended to b O hrishaving same properties as of APLis Quality a Any proutuct thot fulfills customer requirements expectations. Fitness for pumpese shen any produit services i found tobe fit for i's purpose). Working de Ouality is conformance to specifications” Quality of deng product Drug products whieh has follow cy-The product should be effective for i's purpose. Drug product which is not harmful to the patient in any manner. Purity -substance which- Constraints only the ingredients of the formula or intended final product as a percentage of i's potency say 99% or as acceptable, cerrwyo02-01 e) acieoes Conte of Exceonce Farrer) Good Manufacturing Practices ‘nininio Quality of drug product — OD tdentity- The product should be of specifie ‘The product property should fulfill its intended use molecule(s), Strength - 1D 1)he concentration of the drug substance (for example, weight wei Wvalume, oF unit dose volume basis) and or 1D 11)the potency that isthe therapeutic uetivity ofthe product as indicated by the appropriate laboratory tests or by adequately developed and ‘controlled clinical data (expressed for example, in ttm of units by reference toa standard) 1D The product should be of required stee race yvH/o02-0 @S teacieeds Co 9130/2024a actices Dr [ coo Manufacturing P GMP-definition a ET rance, which “GMP(Good Manufacturing Practices) is a part of quality assurance. ality ensures that products are consistently produced & control to the Quality standards, appropriate to their intended use.” Hacleods Contre of excellence icerryoo2-01 @® Good Manufacturing Practices GMP is all about Protecting the product from: a tamination, aa Protecting the product rom Crass Contamination Protecting the product from Weather Protecting the product from pests Protecting the product fom Operational errors 3 Protecting the product fom Q Protecting the product from storage and QO Mociods Cente of Excene |Why GMP. Good Manufacturing Practice (GMP) isa system for ensuring that products are consistently produced and controlled to quality standards, 1 Iis designed to minimize the risks involved in any pharmaceutical production that cannot be ei nal product. D1 Athis really all about the things r re and attention necessary to ensure that we get Int and keep them right, from the start to finish 1 Toassure that pharmaceutical dosage forms meet the customers ( patients) requirements of safety and have the efficacy, identity strength .Auality and purity charaeteristis that they purport to possess The customer’ are sick and convalescent( recovering ) or, debilitated ( \eak) patients, elderly people young children and infants who have little or no knowledge of the product cerT#/002-01, OQ Maceods Centre of Excelence Good Manufacturing Practices Why GMP 1 Drugs have been prescribed by the Medical Profession. An unsafe drug product is harmful to the patient and may even cause death. 1 By merely testing even repeatedly ,the finished product samples the ‘manufacturer is unable to guarantee the identity strength, quality , purity, efi ety of each and every pack or, unit Regulatory (Compulsory Govt. requirement) requirement. Quality which is consiste wasted time. sy and is the most effective way to reduce costs and The cost of rework ,lack of attention to details and errors ean account for substantial (10% or, more ) loss of Company's tumover. Quality provides a cutting edge against business competitors in retani the existing customers and also in yetting new additional customers. wacertHyoo2-01 Macleods Centre of Excellence ————™Good Manufacttirins 5 purpose only when: for jght prod Iris th trig the right streneth Itis free from contamination. rated “Gone bad” oF broken down, itis in the right container. Iris correctly labeled. oO a Oo 1 Ithas in no way deter o o a finer and protected against It is properly sealed in its cont damage and contamination. neermon2-01 4 Nacends Cente of Excelence Good Manufacturing Practices In short: ——— aT © When itis fit to be given to a patient © When it will have the Desired Effects. * When i it will not harm or damage Him or Her, in any way cernmvon2-o4Good Manuf: tices ving P GMP and cGMP EET "cGMP", The letter “e" stands for “current.” oF dynamic, reminding ‘manufacturers that they must employ technologies and syst. up-to-date in order to comply with the eg. Instead of handwritten weights direct print outs of balances D_ cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). 1D cGMPs provide for systems that assure appropriate de: ‘and control of manufacturing processes and facilities. cermo02-01 e acigods Cente of Ex Good Manufactut 2 Practices 10 Basie Principle of GMP al 1. Read & understand-Approved Standard Operating Procedures betore you start the work. 2, Follow the written and approved SOP & WE 3, Do what is written and write what you do. 4 wk 5. Do not carry out any task if confused not understood: 6. Do not assume. 7. Ma 8. Maintain personal Hygiene, juin the werk place elean and tidy 9. Always follow satus kabely Update it as and wie required 10, Read what fs writen, Do not real what you want Co read cet 02 01 >) aot —‘nui g Practices Regulatory agencies across the world. Standard Control Organization. And 1D india CDSCO -Central Dr State Drug Control Authorities. 1 Japan: Ministry of Health and Welfare Pharmaceuticals andl Medical Devices Agency (PMDA), D_ New Zealand : Medsafe~Medicines and Medical Devices Safety Authority oO UK : MHRA--Medicines and Healthcare Products Regulatory Agency [USA — : FDA~The Food and Drug Administration ‘cesr¥/o02-01 ® Macleods Centre of Excellence Good Manufacturing Practices im Few important Regulatory agencies across the world. Se o Pics Pharmaceutics C iarmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme. ‘These are two in ‘vo international instruments between countries and harmaceutical pharmaceutical inspection authorities The PICIS is me ‘Sis meant as an instrument to improve co-operation in the field of Good Manuf facturing Practices (GMP) betw n Regulatory Authorities and Industry, ne D Currently 47 countries sutras are i's members,Good Manufacturing Practices Few important Regulatory agencies across the world.. yonization (ICH). International Couneil for Har World Health Organization WHO), Iherapeutic Goods Administration (TGA), I: National Health Surveillance Agency (ANVISA) Canada : Health Canada, Colombia: Ministry of Health Europe : EMEA--The European Ageney for the Evaluation of Medicinal Products. EMA : European Medicines Agency. yy + Federal Institute for Drugs and Medical De d= Irish Medical Board (IMB), Health Products Regulatory Agency (HPRA) sice/r002-08 © acieods Contre of Excelence Germ: 's ( BIArM). rel Good Manufacturing Practices History of GMP > 1902's : 12 children died due to contaminated diphtheria Anti — toxin.(USA) > 1930's : 75 children died and 168 were injured ~ Oral dose contamination.(EU) 1935's: one drug, sulphanilamide, resulted in 107 deaths - oral clixir contaminated with high levels of a poisonous solvent - diethylene glycol arly 300 people were killed ~ sulphathiazole tablets Us) vice/nwy002-01 © acleods Cente o Excelence ON