PEREGRATION OF PHARMACEUTICAL DRUG Dr. Jignesh Kevalia (Head, Dept. of Ph. Cognosy) Ms. Bechara Hiral V. (B. Pharm IV Year) Mr. Dishant Viravadiya (B. Pharm III Year) Ayurvedic Pharmaceutical industry is one of the most important facets of Indian Economy. Ayurvedic industries are growing rapidly day-by-day. There are Ayurvedic pharmacies around 8000 licensed and the approximate turnover of this industry is Rs.4500 crores, which accounts for nearly a third of total pharmaceutical business in India, which can be considered a very handsome amount. To get more profit, they adulterated and adopted shortcut methods to prepare classical medicines and thus these medicine becomes substandard. In such scenario, there is a need to understand that how a product is designed. Present project work is focused on the understanding of stepwise development of a product from its origin to its final dosage form. Steps of Product Manufacturing 1.GMP and ‘food & Drug Passing’ 2.Drug Cultivation and collection 3.Raw Material Storage and Testing 4.Processing 5.Packaging and labeling 6.Dispatch the product 7.Marketing What is GMP??? Why we must FOLLOW it????????? Medicines…… …. of large world….. of the GMP (Good Manufacturing Practice) is a system for ensuring that products are consistently produced and controlled according to quality standards. GMP is the guidelines which governs the production, distribution and supply of the drug. Very First step towards Ayurvedic drug manufacturing is to take permission from F & D department. But, before that, the company has to get the certificate of GMP from the concerned authority. Most Fundamental Objects Of Ayurvedic Pharmacy is…… Kya Aaj hame jo RAW MATERIAL mil raha he vo shahi he???? In the field of Ayurvedic pharmacy, Raw materials are most fundamental objects. There are two sources of raw materials as follow 1.Wild 2.Cultivated Ayurvedic classical text have suggested to collect wild varieties of plant. Such opinion of texts is given to gain maximum effect of the drug. But in current scenario, when forests are being cut down, crisis of wild variety of plants is taking places. This has forced us to think for a better and reliable option. So, cultivation of raw material came into practice Factors for Cultivation A. Climate conditions C. Quality of water E. Season G. Market Status B. Soil Test and Quality D. Fertilizers F. Propagation and yield Check the material as per the Purchase Order. Stamp on the Challan indicating the date and time of Material entered in the factory. Check the physical condition of material for any damage, if any rejection/Acceptance of damaged container is decided by extent of damages. Details of the Material for its quantity/weight against the Challan and other details like Batch Number, Manufacturing date, Expiry date (if any), name of the supplier, etc are checked. :- Inward register Sampling Report Test Request slip for – RM Test Request slip for – PM Release Slip for – RM Release Slip for – PM Status Labels Identification Loss on drying at 1050 C TLC/HPTLC-Profile with marker compound (wherever possible) Total-ash value Acid-Insoluble Ash value Water-soluble extractive value Alcohol soluble extractive value Assay Test for heavy/toxic metals Microbial contamination DISPENSING Precautions IN PROCESS On-line rejection Cleaned Stock return Status label Recoverable Residues (Salvage) Details of product labels: > Product name > Reference > Ingredients > Maximum Retail Price (M.R.P.) > Manufacturing date (Mfg date) > Expiry date (Exp. Date) > Batch no > License Number (Lic. no.) > Internal or External use > Company name & Address > Weight / Volume > Dose > Precautions Finished products, which are “Under Test”, should be kept in quarantine area. Only “Approved” finished goods should be dispatched as per marketing requirements. “Rejected” stocks should be stored at separate place from “Approved” stock. WHOLESALER STOCKIST DISTRIBUTOR RETAILER Kya he koi jagah jo in sab ka gyan de?????? Kaha se prapt kare in sab ka gyan?????????? IS THERE ANY HUB WHICH GIVES SOUND KNOWLEDGE OF IMPORTANCE OF GMP?????? Charaka Samhita had given emphasis on drug standardization and quality control thousand of years ago itself. Acharyas gave emphasis on all the aspects like properties, special actions, origin of drug, time of collection, method of storage, processing, dose all should be taken in care only then drug will act properly. So from collection of raw material to storage, packaging, supply if all fulfill quality standards only then Ayurvedic drugs can give better results to mankind. Implementation of GMP in Ayurvedic Pharmaceutical units concern may lead to manufacture of safe and efficacious medicine. GMP also validates the processes involved in Ayurvedic pharmaceutics and also facilitates the functioning of regularity authority and ultimately ensures the safety of THANK YOU