2. Blower & Exhaust.

3. Coating Sprayer.

5. Net contents in terms of wt., measure, volume, no. of units of activity (In metric system.)

6. Content of active ingredients.

7. The name and address of the manufacturer.

8. Manufacturing license number or Mfg. Lic. No. or M.L.

9. Batch number – ‘ Batch no.’ or ‘B. No.’ or ‘Batch’ or ‘Lot no.’ or ‘ Lot’.

10. Expiry particulars, if any.

11. Precautionary information.

12. Storage conditions and manner of use.

13. General information such as ‘Physician’ sample, not for sale’ etc.

15. To control the sources of product quality, variation mainly in methods, machines and men.

16. To ensure the correct and most appropriate, manufacturing and packaging practices.

17. To assure that the testing results are in compliance with the standards or specifications.

18. To assure the products stability and to perform other activities related to product quality through a well-organized total quality assurance system.In order that the quality control tests of the sample be indicative of the whole, proper sample selection is essential. Usually two samples are chosen randomly from each batch of capsules, tablets and liquids. The first samples is meant for immediate quality control testing, whereas the second is intended to be maintained under appropriate storage conditions to determine whether or not the samples <br /> <br />QUALITY CONTROL LABORATORY<br />Q.C. refers to the process of striving to produce a perfect product by a series of measures requiring an organizes effect by the entire company or eliminate errors at every stage in production .<br />Q.C. is the part of GMP concerned with sampling, specification and testing with the organization, documentation and release procedure.<br />Various quality control parameter of the “Liquid and Solid” dosage form was evaluated. The instruments that was in quality control laboratory are:- <br />QUALITY ASSURANCE<br />The assurance of product quality depends on more than just proper sampling and adequate testing of various components and the finished dosage form prime responsibility of maintaining product quality during production rest with the manufacturing department. Removal of responsibility from manufacturing for producing a quality product can result in imperfect composition, such as ingredient missing, sub potent or super potent addition of ingredients or mix up of ingredients, mistakes in packaging or filling, such as product contamination, mislabeling or deficient package and lack of conformance to product registration. Quality assurance personnel establish control or check points to monitor the quality of the product as it is processed and upon completion of manufacturing. These begin with raw material and component testing and include in process, packaging, labeling and finished product testing as well as back auditing and stability monitoring.<br />CHAPTER 7<br />STORE ROOM<br />STORE ROOM<br />RAW MATERIAL STORE ROOM:<br />The store room is the place where various materials are stored and preserved until they are issued to the other departments. The area of a storeroom depends upon the nature and capacity of the organization, nature of the item to be stored, frequency of purchasing and issuing of the items. The quantity to be stored, nature of finished products etc. This unit has a centralized store room consisting of a better control, better layout, less space, staff, economy and better stock checking is rendered.<br />The storeroom is almost in the center of the unit and near the section so that transportation of raw materials from store to various sections become very easy & economic. In generally it consists of bulk drugs, raw materials coloring agents, flavoring agents, sweetening agents, various suspending agents tools and spare parts of machine etc. The materials such as coloring and flavoring agents, patent drugs, tools are stored in specific metal, plastic, rubber and cardboard boxes in shelves and racks. The store is categorized in zones for proper handling of the material.<br />The materials are issued to the production departments and the other departments as and when desired by them. This section also maintains an up to date record of receipts and issue of materials. The materials issued from the store are recorded. For maintaining an up to date records, a store ledger is used. It provides information regarding the A/c number of item, description of item, maximum, minimum and recorder and recorder level, quantity received with date, quantities issued with date, batch no. regarding the materials used all other necessary information.<br />PACKAGING MATERIAL STORE ROOM <br />An independent packing materials preparation and storage arrangements systems was available at Jyoti remedies. Interestingly, the various packing materials, among which the card board cartons of differing sizes were prepared at the first floor of the plant. The packing materials included bottles, plastic boxes<br />CHAPTER 8<br />DOCUMENTATION SECTION<br />DOCUMENTATION SECTION<br />DOCUMENTATION AND RECORDS:<br />Documentation is an essential part of the Quality Assurance system and, as such, shall be related to all aspects of Good manufacturing practices (GMP). Its aim is to define the specifications for all materials, method of manufacture and control, to ensure that all personnel concerned with manufacture know the information necessary to decide whether or not tot release a batch of a drug for sale and to provide an audit trail that shall permit investigation of the history of any suspected defective batch.<br />DOCUMENTS REQUIRED<br />Labels<br />Specifications & testing procedures<br />Specifications for starting & packing materials<br />Specifications for intermediate & bulk products<br />Specifications for finished products<br />Master formulae<br />Packing instructions<br />Batch processing records<br />Batch packaging records<br />Standard operating procedures ( SOPs) & records<br />Miscellaneous<br />All these documents are maintained in the factory according to the legal requirements.<br />1. Master Formula Record:<br />To assure uniformity from batch to batch master formula (master production and control) records for each drug product.<br />Procedure: It is to be described in a written procedure and such written procedure shall be dated and signed by competent technical staff and independently checked, checked dated and signed by second person. Master formula record shall includes<br />Name and Strength of the product along with dosage form (if it is pharmacopoeial product under trade name, both names will be given)<br />The name and wt. measure of active ingredients per dosage unit or per unit weight/measure of the product and tablet weight/measure of any dosage unit. <br />A complete list of all the ingredients to be used in the manufacture of the product indicating any special quality characteristics. <br />An accurate statement of weight/measure of each ingredient (same weight system should be used) required as per formula of dosage form and the weight/measure actually to be used (e.g. overages to compensate losses during storage).<br />A statement of theoretical weight/measure at appropriate phase of processing.<br />A statement of theoretical yield including permissible limits beyond which investigation is required.<br />A description of containers, closures and packaging materials to be used.<br />A description of all vessels, equipments to be used in their preparation.<br />Processing and packaging procedures.<br />In process controls to be exercised during processing and packaging.<br />Precautions to be taken during manufacture and storage of semi-finished product. <br />2. Batch Manufacturing Records:- <br />Batch manufacturing records as per Schedule U are prepared for each batch of the drug product. These should be based on master formula records. Method of preparation of batch processing records should be such that transcription errors do not occur.<br />During the manufacturing information listed below should be recorded, signed and dated by the persons responsible for processing operations:-<br />name of the product<br />batch number<br />date of commencement & completion of significant intermediate stages<br />name of the person responsible for each stage of production<br />initial of operators who carried out significant processes and initial of persons who checked, wherever applicable. <br />Quantity, batch number, quality control report number of each ingredient actually weighed and amount of any recovered material added.<br />In –process controls carried out their results and signature of person who performed.<br />Theoretical yield and actual yield at appropriate stage of production together with explanation. If variation beyond expectation observed.<br />Authorization of any deviation if made.<br />HYGIENE & SANITATION<br />The factory was cleaned every morning with disinfectant and water.<br />Double door system was used in liquid section & capsule section to reduce the level of recontamination.<br />Air curtain installed at the entrance of factory to reduce the dust content on cloths of labor.<br />These were separate change room for men and women. <br />The kitchen of the factory was situated on first floor so as to reduce contamination.<br />Exhaust air, air conditioner, humidity meter were installed of various place in the factory. <br />Fire extinguisher was hanged on the wall of gallery.<br />CHAPTER 9<br />MARKETED PRODUCTS<br />Table:- 11 List of Marketed Product<br />Brand NameContentsPkgZeeclox LB capAmoxycillin 250mg,Cloxacillin 250mg, Lactic Acid Bacillus 1.7 Billion capsuleCaps of 10sZeemox 250 capAmoxycillin 250mg capsuleCaps of 10sZeemox 500 capAmoxycillin 500mg capsuleCaps of 10sPanlee DSRPantaprazole 40mg,Domperidone 30mg sustained release capsuleCaps of 10sRabdom-DRabeprazole 20 mg & Domperidone 10 mg Cap10x10CRabdom-DSRRabeprazole 20 mg & Domperidone 30 mg Cap10x10CDobeflowCalcium Dobesilate Monohydrate BP 500 mg10x10CMaxslim 60Orlistat 60mg Capsules10x10CMaxslim 120Orlistat 120mg Capsul;es10x10CFerest-100 CapNatural Micronised Progesterone10x10CFerest-200 CapNatural Micronised Progesterone10x10CEcorich softulesVitamin E Acetate IP 400mcg & Code liver oil BP 300mgSoftules of 10sLipocinMethylcobalamin,Folic Acid,Vitamins B6 & Alpha Lipoic Acid10x1x10CLycomax-PlusLycopene,LArginine,Betacarotene,Lutein,Vitamins & Minerals10x1x10CPregmax-MPregablin 75mg with Methylcobalamin 750 mcg10x1x10CGabamax-M capGabapentin 300mg & Methylcobalamin 500mcg10x1x10CMaxtil 100Cefpodoxime Proxetil USP 100mg DT Tablet10x10TMaxtil 200Cefpodoxime Proxetil USP 200 mg tablet10x10TRoxime 250 tabCefuroxime Axetil 250 mg tablet10x10TRoxime 500 tabCefuroxime Axetil 500 mg tablet10x10 TCeftis-200Cefixime 200 mg Tablets10x10TMaxflox -200Ofloxacin 200 mg tablet (Alu-Alu)10x10TMaxflox-400Ofloxacin 400 mg tablet (Alu-Alu)10x10TMaxflox-OOfloxacin 200 mg & Ornidazole 500 mg Tab10x10TLevomax 500Levofloxacin 500 mg Tablets (Alu-Alu)10x10TRabrolRabeprazole 20 mg (Alu-Alu)10x10TCitrocalciumAlfacalcidol & Calcium Citrate Tablets10x10TLubrilax TabSodium Picosulphate BP 10mg tablet10x10TSwiftase TabSerratiopeptidase 10mg tablets10x10TSwiftact SDiclofenac50 mg, Serratiopeptidase 10 mg tablets10x10TSwiftact 3DDiclofenac Pottassium 50 mg & Serratiopeptidase 15 mg & Paracetamol 325 mg Tablets10x10TSwiftokDiclofenac Pottassium 50mg, PCM 500mg, Chlorzoxazone 250mg, Magnesium Trisilicate 100 mg Tablets10x10TPetra Plus tabTramadol 50mg,Paracetamol IP 500mg10x10TNimbraNimesulide Tablets25x10TNimbra PlusNimesulide & Paracetamol Tablets25x10THB Rise TabFerrous Ascorbate eq.to elemental iron 100mg,Folic Acid IP 1.5mg Tablet10x10TNovacalAlfacalcidol 0.25mcg & Calcium Citrate 1200mg Tablets10x10TBalaneuron-ForteBenfotiamine,Methylcobalamin Adenosylcobalamin,Folic acid,Pyriodoxine Hydrochloride10x10TZeeclox Kid LB tabAmoxycillin 125mg,Cloxacillin 125mg,Lactic Acid Bacillus 1.7 Billion tabletsTabs of 10sZeemox 250 DTAmoxycillin 250mg Dispersible tabTabs of 10sZeemox CV 625Amoxycillin 500mg, Clavulanic Acid 125mg tabletTabs of 10sZithmax 500 tabAzithromycin 500mg tabletTabs of 10sZeemol 650Paracetamol 650mgTabs of 10sMefmol PlusMefenamic Acid IP 500mg,ParacetamolIP 450mgTabs of 10s<br />CHAPTER 10<br />WORK DONE UNDER PRACTICAL TRAINING<br />WORK DONE UNDER PRACTICAL TRAINING<br />“Accept challenges, so you can feel the joy of victory” this is right for me, when I go to this industry “JYOTI REMEDIES”. As it was challenge for me to join this, after joining I feel that I have gained much more knowledge about the pharmacy & works handled in industry. There was a complete friendly nature of the men power of industry.<br />The factory was cleaned every morning with disinfectant & water, so that hygienic environment can be made. I am very grateful to Mr. C.P. Kuriakose (M.D.) & Mr. Sudhir Sharma (M.D.) who give me complete guidance which was necessary for me in completion of this training. JYOTI REMEDIES has bright future as it is among the fastest growing pharmaceutical companies.<br />TABLET :-<br />Brand Name – Mefmol Plus<br />ANTI-INFLAMATORY, ANALGESIC<br />Each uncoated tablet contains:<br />Mefenamic Acid I.P.500 mg<br />Paracetamol I.P. 450 mg<br />Formula for 58,000 tablets:<br /> For 1 tablet, Mefenamic Acid I.P. = 500 mg<br />For 58,000 tablets, Mefenamic Acid I.P. = 500*58,000= 29.0 Kg<br />For 1 tablet Paracetamol I.P. = 450 mg<br />For 58,000 tablets, Paracetamol I.P. = 450*58,000=26.10 Kg<br />Total active ingredients = 55.10 Kg<br />Wt. Of 1 tab. = 1.20 gm <br />Total Wt. = 1.20*58,000=69.6 Kg<br />Lubricants:<br />1) Talc - 2.73%<br />For 58,000 Tablets,<br />(2.73*69.6)/100 = 1.9 Kg.<br /> 2) Magnesium stearate - 1.27%<br /> For 58,000 Tablets,<br /> (1.27*69.6)/100 = .88 Kg.<br />3) Aerosil - 0.907%<br /> For 58,000 Tablets,<br /> (0. 907*69.6/100 = 500 gm<br /> Total lubricants used = 0.63 Kg<br />Disintegrants:<br />Starch - 4.53%<br /> For 58,000 Tablets,<br /> (4.53*69.6)/100 = 3.15 Kg.<br />Binders:<br />1) Starch - 4. %<br /> For 58,000 Tablets,<br /> (4*69.6)/100 = 2.78 Kg.<br />2) Gelatin – 1%<br />For 58,000 Tablets,<br /> (1*69.6)/100 = 0.7 Kg.<br />Moisture content:<br />Moisture - 2 %<br />For 58,000 Tablets,<br /> (2*69.6)/100 = 1.39 Kg.<br />Preservative:<br />Sodium benzoate - 0.0324 %<br />For 58,000 Tablets,<br /> (0.0324*69.6)/100 = 0.02 gm.<br />Diluents:<br />1) Talc - 2.125 Kg.<br />2) Starch - 2.125 Kg.<br /> CHAPTER 10<br />CONCLUSION<br />CONCLUSION<br />As we all know the main purpose of industrial training is to improve the practical skill of the trainee and to acquire him with the environment of the industry and to develop professionalism.<br />Working in Jyoti remedies as a trainee was an excellent experience. I had learnt many new techniques regarding formulation of Tablet & capsule dosage forms. The location and layout of factory was according to the GMP requirements. The technical staff of the factory was very talented, expert in their work. All the employees and workers were very cooperative, disciplined and professional.<br />The Q.C. section was well equipped and all the standards and Q.C. Tests were performed according to the official pharmacopoeias very strictly.<br />In my opinion Jyoti remedies has wide scope for more development in upcoming years and future of the company is bright because of good management and skilled staff in production department.<br />BIBLIOGRAPHY<br />BIBLIOGRAPHY<br />Indian Pharmacopoeia, Government of India, Ministry of Health and Family Welfare, The controller of Publication, 1996, New Delhi.<br />Lachman, L. and Libberman, A. (1991) The Theory and Practice of Industrial Pharmacy, Varghese Publishing House, Bombay.<br />Remington’s – The science and practice of pharmacy, international student edition, 20th ed., 2000 Philadelphia College of Pharmacy and Science, Philadelphia. <br />Ansel’s Pharmaceutical Dosage forms and Drug Delivery Systems’ 8th ed., B.I. Publications Pvt. Ltd., Lippincott Williams and Wilkins, Philadelphia.<br />Bentley’s Text book of Pharmaceutics, 8th ed., Published by All India Traveller Book Seller, Delhi.<br /> Aulton, M. Pharmaceutics – The science of Dosage from Design International Student edition, London. <br />Kohli, D.P.S. and Shah, D.H., Drug formulations, Manual Eastern Publishers, New Delhi.<br />Mithal B.N., ‘Text Book of Pharmaceutical Formulation, Vallabh Prakashan, Delhi.<br />United State Pharmacopoeia, 23rd edition.<br />P.P. Sharma – How to practice GMP (Good Manufacturing Practices) 4th Ed., Vandana Publication Pvt. Ltd., Delhi P.No. 55-57, 215-296<br />