Industrial Training Report (B.Pharma) Medicine
- 1. A PROJECT REPORT ON "INDUSTRIAL TRAINING" SUBMITTED TO DR. A. P. J. ABDUL KALAM TECHNICAL UNIVERSITY Submitted in partial fulfilment of the requirement for the degree of BACHELOR OF PHARMACY By: NEHA GUPTA (Roll No: -2010640500040) Under the Supervision of MS. SHAHEEN ANSARI (Assistant Professor) JIT FACULTY OF PHARMACY , BARABANKI (U.P)
- 2. ACKNOWLEDGEMENT It is my pleasure to be indebted to various people, who directly or indirectly contributed in the development of this work and who influenced my thinking, behavior, and acts during the course of study. I express my sincere gratitude to Ms. SHAHEEN ANSARI for providing mean opportunity to undergo Industrial Training at Manufacturing Unit: Athena’s life science Plot No. 82,83,68, &69 Sector-6A IIE SIDCUL, Haridwar-249403 (Uttarakhand)
- 3. DECLARATION I hereby declare that the information incorporated in the project report is a Bonafede and genuine project report, embodies my own work under guidance and suggestion and received from my supervisor Ms. Shaheen Ansari, JIT Faculty of Pharmacy, Barabanki, (U.P) Submitted to: - MS. SHAHEEN ANSARI (Assistant Professor) JIT FACULTY OF PHARMACY , BARABANKI (U.P) NEHA GUPTA ROLL NO:2010640500040
- 4. CERTIFICATE This is to certify that NEHA GUPTA submitted a Project report on "INDUSTRIAL TRAINING," in the partial fulfillment of the requirement for the award of Bachelor of Pharmacy from JIT FACULTY OF PHARMACY, BARABANKI (U.P) with true and honest observations. He has completed this project under my supervision and his report is satisfactory. Submitted to: MS. SHAHEEN ANSARI (Assistant Professor) JIT FACULTY OF PHARMACY , BARABANKI (U.P) External examiner (Signature)
- 5. CONTENTS Sr. No. Particulars Page no. 1. Introduction 1 About the company Company Profile 1 WHO I GMP Certified Plant Storage 2 Involvement 3 Quality Assurance & Control 4 Mission and Vision 5 Services 7 2. Product Profile 9 Product list 11 3. Plant Layout 18 4. Storage Areas 20 5. Packaging 21 6. Markets 23 7. Quality 24 8. Facilities 25 9. Training Certificate 26 10. Conclusion 27 11. Reference 28
- 6. 1 INTRODUCTION ABOUT THE COMPANY (OM BIOMEDIC PVT. LTD) Company Profile We introduce ourselves as an ethical, scientific based pharmaceutical company committed to manufacturing and marketing "quality pharmaceutical formulations" in the Indian and International markets. OM BIOMEDIC PVT. LTD, a name that is symbolic of "Medicines for Glowing Health, was established in 2001 and for over 22 years has established a strong presence through our dedicated service. At OM BIOMEDIC PVT. LTD, we accomplish our mission through our innovative products and strict quality management system, which also reveals our commitment to quality and customer satisfaction. Every day we are constantly focusing on our vision by manufacturing and marketing a range of quality medicines at affordable prices so that we can keep our society glowing. OM BIOMEDIC PVT. LTD has a particularly strong presence in the anti infective, pain, gynecological, pediatrics, respiratory and gastro-enterology segments. Our well-trained field personnel meet over one hundred thousand qualified doctors and 60000 retail pharmacists across India with each passing year.
- 7. 2 WHO I GMP Certified Plant OM BIOMEDIC PVT. LTD possesses state-of-the-art manufacturing facilities at , Uttarakhand which is WHO GMP certified and complies with the latest quality assurance principles and Quality Management System (QMS). The plant is built to suit the specifications laid down for Good Manufacturing Practices and adheres to the guidelines in both, man and material flow. The plant is maintained in a clean and hygienic state, with every area having stipulated access controls and contamination safeguards. It has state of art HVAC and water system complying to international standards. The entire area is approximately six acres. All products are manufactured under strict current good manufacturing standards. Our Quality control department is fully equipped with sophisticated instruments such as HPLC system, FTIR, UV- Visible, Spectrophotometers, Walk-in-stability chambers, etc. Our manufacturing location is approved by Kenya, Nigeria, Ethiopia & Ivory Coast. Storage All raw materials and finished products are stored under controlled temperature conditions depending on their respective requirements and stipulations. Cold storage rooms are also provided for products requiring low temperature storage conditions. A computerized inventory management ensures precise and updated information at any point of time.
- 8. 3 INVOLVEMENT It is involved in • Pharmaceutical Testing • Food Testing • Water Testing • Testing of Herbal products and Nutraceuticals • Medical Device Testing • Testing of Cosmetic Products • Building and Construction Material Testing • Pre-shipment inspection and sampling of consignments • Environmental monitoring and testing of environmental samples Aglow med specialize in wide gamut of therapeutic segments and nutritional supplement for Human Division, including: • Antibiotics • Anti Ulcer ant • Anti Fungal • Anti Histaminic • Anti Viral • Calcium Channel blockers • Analgesics /Anti-inflammatory • Hematinic OM BIOMEDIC PVT. LTD has also set up Animal Health Division, which primarily manufacture feed supplements & pharmaceuticals for this segment. At present is strongly positioned in several states in India & are on the mission to expand market in domestic & International arena.
- 9. 4 QUALITY ASSURANCE AND CONTROL We at OM BIOMEDIC PVT. LTD are committed to satisfying our customers by providingproducts to their specified and implied requirements. At the same time, efforts for continuous improvement at all different levels of the system are our priority. Our full-fledged quality control department and experts, technically qualified scientists ensure that strict quality control is maintained and medicines are produced meticulously, which guarantees excellent quality and effectiveness. A separate quality assurance department has been specially set up to constantly supervise each and every production stage and to ensure cGMP compliance as well as adhere to in-house standards. Our R&D Department looks after the research and development of new formulations while still working on improving the current formulation process as well.
- 10. 5 MISSION AND VISION Mission OM BIOMEDIC PVT. LTD has a corporate mission - Consistently strive to provide quality medicines and innovative healthcare services that is accessible, affordable & beneficial worldwide OM BIOMEDIC PVT. LTD sees its role as change agent by manufacturing, marketing and distributing therapeutically effective medicines at affordable prices; thus making health a viable choice for the millions across the world. Vision To spread the glow of good health & relieve human sufferings with quality healthcare services across the globe As a company, OM BIOMEDIC PVT. LTD is deeply committed to fulfilling the vision of a healthy, glowing world population by positioning itself as a strongand capable player in both national and international markets, maintaining the highest levels of operational excellence across all its activities. Our Values To encourage our associates to deliver their best with an environment that reflects Teamwork We believe to instill team spmt, acknowledge team achievements, promote creativity to ensure performance and success to each team member. Transparency We believe in creating a healthy work environment by appreciating merit, individual expertise and excellence
- 11. 6 Integrity We shall be clear, honest and sincere in all our dealings within our team and business partners Commitment We shall uphold ethical practices, fulfill our promises and strive to be a good corporate citizen Quality we shall achieve the highest manufacturing and operating standards through continuously updating and improvising in all activites Recognition We shall reward achievements, encourage innovations and drive individuals towards highest levels of performance Ownership We shall take pride in being committed, with an ever-growing sense of belongingness to Aglowmed family through our every act and deed
- 12. 7 SERVICES We are one of India's largest contract research and testing organization offering a single point, comprehensive solution for all your analytical, testing and research needs to ensure the product quality right from the product development up to market launch. We work closely with you across the entire product life- cycle and help you ensure the product quality at each stage which is critical for market success. Supporting you right from the idea level starting with competitor products evaluation and bench-marking to decide the specifications for your products. We also support you with ingredient analysis for selecting the best ingredients even before the proto type development begins and also test prototypes for compliance with internal as well as regulatory requirements. We provide analytical and quality control testing support during scale up and process validation studies and also conduct stability studies to establish the shelf life of your products. Our clinical research team is experienced in conducting clinical evaluations such as bioequivalence studies, clinical trials whenever they may be required for supporting claims or regulatory approvals. Once the product goes into commercial manufacturing we support you with monitoring the manufacturing facilities, testing the raw materials,
- 13. 8 QC release testing of the products and ongoing stability studies. We also carry out mystery shopping and product evaluation, as a large number of our clients rely on third-party Manufacturing sites and require us to collect samples from the market and test them for compliance to internal as well as regulatory requirements. In the case of market complaints we also support you with full investigations to identify the cause, validity and the impact of such complaints by testing the products and the ingredients used for manufacturing the particular batch. We believe in partnering with you and working as a part of your team and not just as a black box where you can send your samples andget a testreport. With this spirit we have been for over 25 years working with clients across industries such as- • Pharmaceuticals • Food • Water • Nutraceuticals • Herbal and AYUSH • Cosmetics • Homecare • Medical Devices • Build in Construction Materials and many more
- 14. 9 PRODUCT PROFILE OM BIOMEDIC PVT. LTD has a huge product basket includes Branded and Generic Formulations covering the majority of therapeutic segments for all oral dosage forms. OM BIOMEDIC PVT. LTD is a manufacturer of pharmaceutical formulations mainly Human At present OM BIOMEDIC PVT. LTD is in the process of consolidation of the product portfolioin the selected segment and are looking to further strengthen its offerings. OM BIOMEDIC PVT. LTD is also concentrating its efforts to build and enhance portfolio in the chronic health, nutraceutical and food segment, thus creating a healthy balanceofboth acute and chronic therapies. More than 700 formulations Generics Branded Generics NDDS Therapeutic Categories Antibiotics Ami Tubercular Anti Epileptic Antacid Anti Diabetic Anti Malarial Anti Histaminic Cardio Vascular Anti Diarrhea Laxative Anti Migraine/ Anti Vertigo Cough Medicine Analgesics/ Antipyretics Anti Asthmatic Psychotropic Anti Emetic/ Anti Nausea Steroids Minerals/ Calcium
- 15. 10 Global Presence On grounds of Global Presence, OM BIOMEDIC PVT. LTD - especially through its rapidlyexpanding product ranges - intends to position itself as amarket leader internationally. India OM BIOMEDIC PVT. LTD has been present in India for over 30 years and has established a strong presence in the - ethical - pharmaceutical market across the country. OurMarketing and Sales team at OM BIOMEDIC PVT. LTD consist ofhighly qualified and capable professionals who strive for excellence in marketing medicines of the highest standards to the medical fraternity and disseminating the latest medical updates about current brands and future products. Ensuring the availability of products at maximum retail pharmacies across our area of operations is another distinct strength. In addition, continuous monitoring of the disease patterns, of the need of practicing doctors and of our R&D initiatives are built into our aggressive corporate growth plan.
- 16. 11 PRODUCT LIST S.NO. GENERIC NAME STRENGTH Dosage - PACK ANTI-BACTERIALS 1 Ciprofloxacin Tablets USP 250 mg & 500 mg 1O's Tablets - Blister/ Alu-Alu 2 Levofloxacin Tablets 250 mg, 500 mg 1O's Tablets - Blister/ Alu-Alu 3 Norfloxacin Tablets 400mg 1O's Tablets - Blister/ Alu-Alu 4 Ofloxacin Tablets 200 mg, 400 mg 1O's Tablets - Blister/ Alu-Alu 5 Linezolid Tablets / Linezolid for Oral Suspension 600 mg, 100mg I 5 ml 4's Tablets Strip 30 ml -Dry Sy. bottle 6 Chloramphenicol Oral Suspension 125 mg/5ml 60 ml Suspn. - Bottle 7 Azithromycin Tablets 250 mg, 500mg 6's Tablets Strip 8 Erythromycin Stearate Tablets / Erythromycin Estolate Suspension 250 mg.,500 mg & 125 mg/5ml 10 Tabs- Blister & 100 ml- Supn. -Bottle 9 Cotrimoxazole Tablets / Suspension (400+80mg) , (800+160mg) & (40+200mg/5ml) 10 Tabs- Blister 100 ml -Supn. -Bottle ANTI-DIARRHOEALS / ANTI-INFECTIVES 10 Ciprofloxacin & Tinidazole Tablets / Suspension 500 + 600 mg & (125 mg+ 100 mg/ 5ml) 10 Tabs- Blister / Alu-Alu & 30 ml -Supn. -Bottle
- 17. 12 11 Ofloxacin & Tinidazole Tablets 200+600 mg 1O's Tablets - Blister/ Alu-Alu 12 Ofloxacin & Omidazole Tablets 200+500mg 1O's Tablets - Blister/ Alu-Alu 13 Ofloxacin & Omidazole suspens10n 50 mg+ 125 mg 30ml- Bottle Dry Sy. 14 Metronidazole Tablets / Metronidazole Benzoate oral Suspension 200,250 mg & 125mg/5ml 10 Tabs- Blister & 100 ml- Supn. - Bottle ANTI-FUNGALS 15 Fluconazole tablets 150mg. l's Tablet Strip 16 Griseofulvin Tablets B.P. 500mg 1O's Tablets - Blister/ Alu-Alu ANALGESICS , ANTIPYRETICS & ANTI-INFLAMMATORY 17 Diclofenac Tablets BP 50mg, 100 mg 1O's Tablets - Blister/ Alu-Alu 18 Diclofenac and Paracetamol Tablets 50 +500 mg lO's Tablets - Blister/ Alu-Alu 19 Aceclofenac and Paracetamol Tablets 100 +500 mg 1O's Tablets - Blister/ Alu-Alu 20 Ibuprofen & Paracetamol Tablets / Suspension (400+500 mg), 100+125mg/5ml 10 Tabs- Blister / Alu-Alu & 60 ml -Supn. -Bottle 21 Ibuprofen Tablets / Suspension 200 mg, 400 mg, 100mg/5ml 10 Tabs- Blister / Alu-Alu & 100 ml -Supn. -Bottle 22 Paracetamol Tablets /Suspension 500 mg, 125 mg/5ml 10 Tabs- Blister & 60 ml - Supn. -Bottle 23 Diclofenac Pottassium & Paracetamol, Trypsin & Chymotrypsin Tablets 50mg+325mg+50000AU lO's Alu-Alu Strip
- 18. 13 ls.No.lGENERIC NAME I STRENGTH I Dosage - PACK EXPECTORANTS, AN DECONGESTANT TITUSSIVES, MUCOLYTICS & 24 IBromexine HCl Syrup 14mg/5ml 1100ml - Bottle I I I 25 I Salbutamol Solution 12mg/5ml 1100ml - Bottle 26 Salbutamol, Bromhexine & Phenylephrine Syrup 4+8+5 mg/10ml 100ml - Bottle 27 Dextromethorphan, Chlorpheniramine, Guaiphenesin & Ammonium Chloride Syrup ( 5 + 2 + 50+75 mg) 15ml 100ml - Bottle 28 Ambroxol, Terbutaline, Guaiphenesin & Menthol Syrup ( 15 + 1.25 + 50 + 2.5 mg) 15ml 100ml - Bottle 29 Levosalbutamol, Ambroxol & Guaifenesin Syrup 0.5 + 15 + 50 mg 60 ml 30 Diphenhydramine, Ammonium Chloride, Sodium citrate & Menthol Syrup (14.08 +138 + 57.03+1.14 mg) I 5ml 100ml - Bottle 31 CODEINE Phoshate, C.P. maleate syrup 10 + 4 mg 15ml 100ml - Bottle 32 Chlorpenamine, Phenylephrine, Paracetamol, Sodium Citrate & Menthol Syrup lmg+5mg+125mg+60mg+ 1mg 60 ml 33 Terbutaline & Bromhexine Syrup 2.5mg+8 mg. 100ml 34 CP Maleate, Phenylephrine, Paracetamol & Caffeine Tablets (2mg + 5 mg+ 500 mg + 30 mg) 4's Tablets Strip I Catch Cover
- 19. 14 Paracetamol, Sodium Citrate, Phenylephrine, Chlorphenamine & Levomenthol 125+60 + 1+5+ 1 120 ml 35 Cyproheptadine & Tricholine citrate Syrup ( 2 mg+ 275 mg) I 5ml 100ml, 200 ml - Bottle ANTI-ALLER GICS 36 Cetirizine Tablets 10 mg 1O's Tablets - Blister 37 Promethazine Tablets / Syrup 25 mg, & 5mg/5ml 10 Tabs- Blister & 100 ml - Syrup -Bottle ANTI-MALARIALS 38 Artewether + Lumefantrin mg+ 4 mg Tablets Dry Syrup Tablets / 80 20 mg+ 120 mg Dry syrup 180 mg+1080 mg 160ml 39 Sulfadoxine and Pyrimethamine Tablets / Suspension 500+25 mg. & 250 + 12.5 mg/5ml, 10 Tabs- Blister & 10 ml - Supn. -Bottle 40 Artesunate Tablets 50 mg I 100 mg 6's Tablets - Blister 41 Tablets Artesunate + Tablets Amodiaquine 100 mg + 306.2 mg (3+3) Combipack: 6's Blister/ Alu-Alu 42 Amodiaquine Tablets /Suspension 200mg, 50 mg/5ml 3 Tabs- Blister / Alu-Alu & 60 ml -Supn. -Bottle HYPERACIDITY, ULCERS & ANTACIDS 43 Dried Aluminium Hydroxide +Magnesium 250+250+50 mg, 830+185+50mg/5ml 10 Tabs- Blister & 150 ml - Supn. -Bottle
- 20. 15 Hydroxide+Dimeticone - Tablets / Suspension 44 Omeprazole & Domperidone Capsules 20 mg + 10 mg 10 Capsules - strip 45 Omeprazole Capsules 20mg 10 Capsules - strip PRODUCT LIST S.NO. GENERIC NAME STRENGTH Dosage - PACK 46 Pantoprazole & Domperidone Tablets 20 mg+ 10 mg l0's strip 47 Pantoprazole Tablets 40mg l0's strip ENZYMES, DIGESTIVE SUPPLEMENTS 48 Fungal Diastase & Pepsin Capsules/ Syrup 50 + 20 mg , 50 mg + 10 mg/ 5 ml 15 Capsules - strip 200 ml. - Bottle 49 Fungal Diastase(!:2000) with Carminatives Syrup 200ml LAXATIVES 50 IBisacodyl Tablets BP 15mg 11O's Tablets - Blister ANTHELMINTICS 51 Albendazole Tablets / Oral Suspension 200 mg, 400 mg & 200mg/5ml, 2's & l's Tablet - Blister 10ml suspn. Bottle 52 Mebendazole Tablets / Oral Suspension 100 mg & 100mg/5ml 6 Tabs- Blister & 30 ml -Supn. - Bottle
- 21. :;.- 16 PRODUCT IMAGES Pantoprazole Fo - r Injection . ,·1 ._ /;. 4, ",}- ..: y" . For IV. use only ··· .n" ,. ,;" . ·,/. ff''·' -l , · " J .J f -:■ ■-· -■ ■ -· ,.,,,, OM 13.JOMf.DI<: P'VT,, IJ'"D. ,,.1 :•- ,+ ;"f:•· 10 X 10 Tablet; • •I• I Montelukast & LevocetirizineDi Hcl. Tablets ffi OM rnOHEDIC M, LlD, Oxytocin Injection I.P. 5.0 IU / ml OXYTOCIN Artemether & Lumefantrine Tablets
- 22. 17 _, _, _,,. .... Lactic Acid BacUlus·,-ablets -- - Ce:ftriiax.one for lnje1cUon IP 1000 m1 g CEFTRIAX1 ON'E INJECTION ffl ..., Twi1n Pack
- 23. 18 PLANT LAYOUT MANUFACTURING TABLET In Pharmaceutical products, there are various types of Tablets in a range of physical appearances, from high gloss, rounded, sugar coated pieces to the geometric, punched shaped of film coated products. The shape, size and color are all visual characteristics reflected by the core and the coating such as sugar coat, film coat. The shape of the core is a key factor in the overall appearance of the Pharmaceutical tablet, not directly as a cosmetic influence, rather as the foundation for an applied coating system. Types of Tablets • Sugar Coated Tablets • Film Coated Tablets • Soft and Hard Gelatin Capsules Sugar Coated Tablets: Traditional sugar coating is performed in what is generally described as a conventional coating pan. However, the desire to reduce the time needed for the sugar coating process has led to the trend toward side vented pans. Sugar coating liquids used in preparing sugar coated tablets contain binders such as Gelatin or Gum Arabic so as to increase strength of the sugar coating layer or to increase strength between an uncoated tablet and the sugar coating layer. Film Coated Tablets: Film coating is the largest sector of the tablet colouring market in Pharma Industries. Film coating techniques reduce process times, offer greater control over coating parameters and provide more opportunity for innovation. Film coating involves the deposition of a thin polymer layer onto the tablet core usually by spray methods.
- 24. 19 Soft and Hard Gelatin Capsules: The basic difference between hard and soft gelatin encapsulation process is that in the hard gelatin capsule process, the capsule is prefabricated and supplied empty, whereas in the soft gelatin capsule process the encapsulation and filing takes place simultaneously. Tablet Coating Machine: The High Efficiency Automated Tablet Coating Machine is mainly used in pharmaceutical and food industries. It is a high efficiency, energy saving, safe and clean equipment for film and sugar coating of tablets, pills and candies with organic film, aqueous coating and sugar film etc. Working: The tablets to be coated make continuous complicated orbital motion in the closed rotating drum under the action of a streamline of baffles. During the motion coating medium automatically sprays according to the technological process and rational technological parameters, at the same time hot filtered air supplied under a negative pressure. CAPSULE In Pharmaceutical Industry, there are various pharma company manufactures types of machineries for the different process and application as per there specialty. There are vast categories of pharma machineries as each process requires different machineries. Such as Pharma machines for tablet filing. Machines for tablet counting, machines for tablet pressing and machines for tablet labeling etc. In the capsule manufacturing process first gelatin and hot demineralized water are mixed under vacuum in gelatin melting system. After aging in stainless steel receiving tanks the gelatin solution is transferred to stainless steel feed tanks. Once drying is complete the pin bars enters the table section which positions the capsule halves for striping from the pins in the automatic section. In the automatic section capsule halves are individually stripped from the pins. The cap and body lengths are precisely trimmed to a 0.15 mm tolerance.
- 25. 20 STORAGE AREAS Storage area should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Storage areas should be of sufficient capacity to allow the orderly storage of the various categories of materials and products, namely starting and packaging materials, intermediates, bulk and finished products, products in quarantine and released, rejected, returned or recalled products. Precaution must be taken to prevent unauthorized persons from entering storage areas. Storage Condition: Storage conditions for pharmaceutical products and materials should be in compliance with the labeling, which is based on the results of stability testing. Monitoring of Storage Conditions: Recorded temperature monitoring data should be available for review. The equipment used for monitoring should be checked at suitable predetermined intervals and the results of such checks should be recorded and retained. Labeling and Containers: All materials and pharmaceutical products should be stored in containers which do not adversely affect the quality of the materials or product concerned and which offer adequate protection from external influences. In some circumstances this could include bacterial contamination. Stock Rotation and Control: Periodic stock reconciliation should be performed by comparing the actual and recorded stocks. All significant stock discrepancies should be investigated as a check against inadvertent mix-ups and/or incorrect issue.
- 26. 21 PACKAGING Packaging can be defined as an economical means of providing presentation, protection, identification, information, containment, convenience and compliance for a product during storage, carriage, display and until the product is consumed. Packaging must provided against climatic condition biological, physical and chemical hazards and must be economical. The package must ensure adequate stability of the product throughout the shelf life. The external image of the package must not only compliment product confidence but provide clear and concise product identification and other features included are: • Package should assist in patient compliance • Package should preferably have an aesthetically The primary packaging consists of those packaging components which have a direct contact with the product. The main functions of the primary package are to restrict any chemical, climatic or biological or occasionally mechanical hazards that may cause or lead to product deterioration. Packaging must also function as a means of drug administrations. The packaging external to the primary package is known as the secondary packaging. The secondary mainly provided the additional physical protection necessary to endure the safe warehousing and for refill packaging.
- 27. 22 Material Type Examples Glass Primary Metric medical bottle, Vial, Ampoule Plastic Primary & Secondary Ampoule, Vial, Infusion Dropper Bottle & Wrapper to contain Primary Pack Cardboard Secondary Box to contain primary pack Paper Secondary Labels, Patient information Leaflet Function of Packaging: • Protective function • Storage function • Loading & Transport function • Identification
- 28. 23 MARKETS OM BIOMEDIC PVT. LTD operates in domestic as well as exports markets.More than 75% oftotal production being exported. About 200 products are registered and being regularly exported to various countries Afghanistan,Iraq, CIS Countries, African Countries etc. The main market is represent et below with the major segment: Exports Ethical Sales Animal Health Division Institutional Supplies Approved regular supplier of medicines to Government Institutions like Railways, Central Government Health Schemes. Major hospitals like RML Hospital, LRS Hospital, Kalawati Saran Hospital, G.B. Pant Hospital, SVBP Hospital Meerut, Safdarjung Hospital, Municipal Corporation of Delhi, Assam Rifles, J&K Hospitals, Medical Stores Depot for various states like Haryana, Himachal Pradesh, Punjab, Uttar Pradesh etc. The company ensures the specific execution of orders to meet customer's quality specifications, time schedules and competitive pricingneeds. Exports to Number of Countries: Nepal Bhutan Ghana Nigeria Kenya Myanmar Ethopia
- 29. 24 QUALITY At OM BIOMEDIC PVT. LTD we believe in "Excellence through Quality" OM BIOMEDIC PVT. LTD maintains strict quality parameters for themanufacturing anddistribution of products. We have independent Corporate Quality Assurance Department responsible for quality affairs. Achieved head of state position through our supreme levels of quality. We believe to deliver highest level of quality and customer satisfaction. ISO 9001:2008 Certification and ISO / IEC 17025:2005 Accreditation explain our efforts to achieve maximum quality level. Quality Assurance is a measure of the degree of sophistication of managerial, scientific and technical tools used in the plan and execution of product process of any industry. In the pharmaceutical industry QUALITY is the most fundamental task of Total Quality Management. We at Aglowmed are committed to ensure that every product we manufacture and distribute meets with and conform over its shelf life to internationally accepted standards of quality, purity, efficacy and safety. OM BIOMEDIC PVT. LTD quality focus encompasses all areas of operation - from procurement of the best raw materials, to optimum manufacturing technology, to precise delivery of the customer's requirements - thus ensuring a rapid access of both domestic and global markets. All our systems are well documented and are implemented by an expert trained staff with a line of reporting that is independent of manufacturing. We have state of the art laboratory with the advanced infrastructure and procedures to support a stringent quality policy. At our manufacturing site, the latest analytical instruments and firmly monitored quality assurance and quality control systems ensures consistent quality of our products. There is regular validation of processes, test methods, water and environment, as well as periodic calibration of all instruments, to guarantee product output of consistent top quality. Vendor evaluation and selection is carried out as per stringent quality, product, manufacturing, service and delivery parameters to ensure the highest quality raw materials.
- 30. 25 FACILITIES OM BIOMEDIC PVT. LTD is committed towards quality services, having distinct areas as: Administration Area, Change Room Area, Raw Material Storage Area, PackingMaterial Storage Area, Tablet Section Area, Capsule & Powder Section, LiquidSection Area, and Finished Goods Storage Area & Quality Control Lab Area. OM BIOMEDIC PVT. LTD specialize in Beta-Lactam antibiotics and have distinct Beta-Lactam Capsules/Dry Syrup Section, located distinctively away from Non-Beta Lactam Section. As required by GMP & WHO standards capacity up-gradation programme is underway, where by the output will go up even higher in the coming months. SALIENT FEATURES: Upgraded to Schedule-M. lISO-9001-2008 Certified unit. WHO approved for Lactam group of Tablets, Capsules, Dry Syrup and Non-Lactam Group of Compressed Tablets. Water treatment plant with R.0. Treatment, passing through Carbon Bed, UV, Double Bed and Mixed Bed De-mineraliser. • 2 conventional + ones crew type compressor along with air drier (capacity130 CFM.) In-house QC department has backup for testing facilities of Govt. Approved Commercial Test House located at short distance. • Accorded GMP certification valid up to Nov.20llby Food and Drugs Board Ghana. More than 75%of total production being exported. More than 6000 sq ft. of area available for expansion of manufacturing operations.
- 31. 26 TRANING CERTIFICATE OM BIOMEDI ull 1 Manuf r H:1 im udent f 8. Ph rm Hird ul ) of Ph rm .', 8. r lJ) n1 int tr ining prog1 111 as p r Lhe request uh1mlted by hi h1mseU' fr m I 5/0M/2023 I fl! 12023 in our t-,ro<lucli n D£p a·tm nl an h C een gi, · pr I bn fin_ !um hy our depanmcn1 I h ad.. [1 I. unhcr C rt1lied mat durin lht: C ur.e of rainin 1 he 8 in earrun the 1111Ol'k kmm le lgt·. Thanking• u. h r O I 8 l .P I. LI I. UE udh - HR OMBIOM Plot No ohd. cho lo, . Thi· is 1
- 32. 27 CONCLUSION Although I have mostly spent my training in Quality Control Department . I got incerdible knowledge about the instrumentation ,testing, hardwork, and learnt from my mistakes . It was an oppurtunity for me to see the machine and manucturing process withstand by myself in person. And I used that to hone my skills. The chemicals and the uses of the knowledge that was only limited to books was happening around me in QC department. After that I was assigned to Production and there I learnt about all the process of making drugs from raw materials to finally packaging of them in their pre determined method , Tablet ,Syrups ,capsules ,dry syrups and different types of dosage forms their manufacturing packaging testing was indetailed knowledge aquired by me. It was a astonishing moment and exciting experience of expanding my practical knowledge. At last I conclude by thanking all the teacher senior and the traning staff who helped me from time to time at every step.
- 33. 28 REFERENCE Remington: The Science and Practice of Pharmacy Pharmaceutical Sciences Vol. I and III, Mack Publishing Company, U.S.A. Avis R.E., Pharmaceutical Dosage Forms: Parenteral Medication, Vol-I, Marcel Dekker Inc, New York & Basel. Ansel H.C., Introduction to Pharmaceutical Dosage Forms , Lea & Febiger, Philadelphia, U.S.A. Khar R. K., Vyas S.P., Ahmad F., Jain G. K., The Theory and Practice of Industrial Pharmacy, 4th Edition, CBS Publishers and Distributors. Dinda S. C., Advances in Pharmaceutical Technology, PharmaMed Press. Ansel H.C., Pharmaceutical Dosage Form and Drug Delivery System. Sankar, V. Ramesh S., Shanmugam V., A Text book of Novel Drug Delivery System, PharmaMed Press. Subrahmanyam C.V.S., Setty T. J., Pharmaceutical Engineering, Vallabh Prakashan. Bentley's (E. A. Rawlins), Textbook of Pharmaceutics , AITBS Publishers. McCabe W. L., Smith J. C., Unit Operations of Chemical Engineering, MGH.