pharmaceutical industrial visit report

A VISIT ON PHARMACEUTICAL INDUSTRIAL ORIENTATION

About Authors: Dr. D.k. Sanghi, Rakesh Tiwle*, Puja Karanjekar, Priyanka Hemne, Dileshwari Madavi, Padma Tembhre Shri Laxmanrao Mankar Institute of Pharmacy, Amgoan, Gondia, Maharashtra, India- 441902. [email protected]

Abstract A pharmaceutical formulation and its research invasis play important role in the young generation of the pharmacy students because without seeing the process we don’t know about the formulation and development of any medicine because of that a industrial visit should be compulsory to the pharmacy students. Pharmaceutical industry is a most diverse, R&D oriented, hypercompetitive and knowledge sensitive industry. Competitive intelligence (CI) is a process of ethically and systemic data gathering from operating system to draw important business conclusions. Use of CI for drawing important conclusions regarding present scenario and future forecasting is very important and growth determining practice of pharmaceutical industries. Intellectual property rights (IPR) is an integral part of the industry and IPR related information is freely available in public patent databases. By analyzing patents company can derive important conclusion regarding competitor’s R&D activities, quality of research, collaboration and alliance and can convert this information to knowledge which can play important role in taking future decisions. Present review is fully focused on advent of IPR in getting very good information regarding competitor’s strategies and tactics.

INTRODUCTION Pharmaceutical industry in one of the prominent industry though out the globe and further it is in growing phase 1, 2 , so innovative activities and strategies play important role in the growth of industry 2, 3 . However the flip side is that, there is stiff competition between companies for same drug molecule, same disease area or for the same treatment 3, 4, 5 . Ethically looking over strategies and tactics of Competitors, company can drive important conclusions regarding present scenario and can also forecast about future , 6 . Intellectual property rights (IPR) is an integral part of the pharmaceutical industry 7, 8 . Information of patents is freely available in various patent databases. By analyzing intellectual property (IP) information important conclusion regarding rivalry activities can be drawn out 7, 8 , so pharmaceutical industry uses IP as a tool for competitive intelligence (CI) 8, . Further advents of IP in CI are elaborated in coming section.

GMP - It is the sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use. WHO defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization?” GMP covers all aspects of the manufacturing process: defined manufacturing process; validated critical manufacturing steps; suitable premises, storage, transport; qualified and trained production and quality control personnel; adequate laboratory facilities; approved written procedures and instructions; records to show all steps of defined procedures have been taken; full traceability of a product through batch records and distribution records; and systems for recall and investigation of complaints.

Quality assurance- It is the sum total of the organized arrangements with the objective of ensuring that products  will be of the quality required for their intended use.

Quality control- Is that part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use.

Figure 1: Flow Chart of GMP.

DRUG DEVELOPMENT STAGES

Stage 1 The first stage, the discovery of a potential NME, is not covered by a regulatory standard, nor is studies that demonstrate proof of concept. The WHO has recently published guidance on this early research phase : Quality Practices in Basic Biomedical Research – QPBR.

Stage 2 The position of GLP studies within the drug development process is specific to the second stage. These studies are termed “non-clinical” as they are not performed in humans. Their primary purpose is safety testing. Toxicology and safety pharmacology studies, with a potential extension to pharmacokinetics and bioavailability, are those studies where compliance with GLP is required. From the diagram above.

Stage 3 The third stage, following on from safety studies of stage 2, encompasses clinical studies in human subjects. Here, GCP is the basic requirement for quality standards, ethical conduct and regulatory compliance. GCP must be instituted in all clinical trials from Phase I (to demonstrate tolerance of the test drug and to define human pharmacokinetics) through Phase II (where the dose-effect relationship is confirmed) to Phase III (full scale, often multi-centric, clinical efficacy trials in hundreds or thousands of subjects).

Stage 4 The fourth stage is post-approval. Here the drug has been registered and is available on the market. However, even after marketing approval, the use of the drug is monitored through formal pharmacovigilance procedures. Any subsequent clinical trials (Phase IV) must also comply with GC.

VISITED PHARMACEUTICAL INDUSTRIES

Vama Pharma

Figure 2: Arco Pharmaceutical

Vama Pharmaceutical has been established in 2006 based at central India's largest city Nagpur, Vama Pharma is an integrated  pharmaceutical company, producing a wide range of quality products that have earned the trust of the medical fraternity in states of India. Central India's premier pharmaceutical manufacturing company Vama Pharma is a single-point source for all your pharmaceutical and contract  manufacturing requirements. They  have highly experienced technical team for manufacturing pharmaceuticals preparations &  manufacture pharmaceutical formulations in according to the cGMP norms. In that industries a world-class, manufacturing plant is equipped with all amenities & high standard machineries to manufacture medicines We have highly qualified and trained staff for production management.

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Products of Vama Pharma

DEEPTI PHARMACEUTICALS Deepti Pharmaceuticalsis a registered company under Indian Pharmacopoeia to deliver quality Pharmaceuticals Products. They are Manufacturer and Supplier of a wide range of pharmaceutical products that are supplied to the different parts of the country. The major products of the company include Benzyl Benzoate, Borax Glycerin, Glycerin, Glycyrrhiza, Hydrogen Peroxide Solution, Isopropyl Alcohol, Sodium Bicarbonate, Turpentine Liniment, Cough Syrup and Ginger etc best quality products are the outcome of continuous research and development with the latest technology of advanced medical science. All the products are properly examined and tested by the dept professionals to provide the reliable, effective and immediate healing. They manufacture the products under strict vigilance and from the best quality raw material that we obtain from reliable sources. The products are supplied to the different states of India in the fine quality packaging to retain their good condition.

Products of Deepti Pharmaceuticals

Turpentine Liniment I.P. We are engaged in manufacturing and supplying of Turpentine Liniment I.P. to all government hospitals of Maharashtra and Karnataka. It is available in packing of 100ml, 400 ml, and 500 ml. We provide high quality Turpentine Liniment I.P. that is properly tested and made to provide effective and immediate relief from rheumatic pain, counter irritation, etc. Turpentine Liniment I.P. is supplied to various parts of the country. Our Turpentine Liniment I.P. is made from the best quality raw material to provide tension free solution to our clients.

Isopropyl Alcohol I.P. Isopropyl Alcohol I.P.are supply to various states of the country. Isopropyl Alcohol I.P. is properly tested by the expert professionals of the company before delivering to the customers. Our Isopropyl Alcohol I.P. is made from high quality raw material that we obtain from trusted sources. The solution is available at an affordable market price for the clients.

Hydrogen Peroxide Solution I.P We are one of the manufacturers of Hydrogen Peroxide Solution I.P. I.P 20 vol available in 100ml, 450 ml, and 5 lit packing. Our Hydrogen Peroxide Solution I.P. is the perfect solution to use as an antiseptic treatment. The product has been properly tested to provide effective and immediate solution for the specific purpose. Our Hydrogen Peroxide Solution I.P. is made from the best quality raw material that we collect from trusted sources. Our Hydrogen Peroxide   solution I.P. is available at an affordable market price.

ARCO PHARMACEUTICALS Arco Life Sciences (I) Pvt. Ltd. is a central India based reputed pharmaceutical formulation manufacturing company. The production facilities are located at MIDC Area, Hingana, Nagpur. It possesses one of the best and modern manufacturing facilities in the area.

Arco Life Sciences (I) Pvt.Ltd. was established in April, 2004. Arco is running successfully since inception and achieveing new heights day by day. under the experienced leader ship of Dr.N.D.Agrawal (M.pharm, Ph.D, DBM), Director of the company. He was developed this unit up to the mark of standard ISO-9001:2008 within this short period. He is very much attentive towards quality control and research and development in his Organization.

Brand product ACINORM (Ranitidine Inj. I.P., 25 mg/ml), ARMIKACIN (Amikacin Inj. I.P., 50 mg/ml), BIOCIN (Gentamicin Sulphate Inj. I.P., 40 mg/ml),

R-PRIN (Heparin Sodium Inj., 5000 IU/ml)

Generic name Atropine Sulphate Inj. I.P.(0.6 mg/ml), Adrenaline Inj. I.P. (1 mg/ml), Aminophylline Inj. I.P. (25 mg/ml), Chloroquine Phosphate Inj. I.P. (40 mg/ml),

Opthalmic product Gentamicin Eye Drops I.P. (0.3 % w/v),  Norfloxacin Eye Drops I.P. (0.3 % w/v), Ciprofloxacin Eye Drops I.P. (0.3 % w/v).

SCOPE OF PHARMACEUTICAL TRAINING 8 Pharmaceutical training give us deep knowledge about the formulation and quality of the products. It gives an idea about industrial orientation, it enhance the practical skill of the students, It gives an instrumental handling

CONCLUSION Competitive intelligence CI can play important role in hypercompetitive, highly R&D oriented and knowledge sensitive pharmaceutical industry.  By analyzing IP back ground important conclusion regarding R&D activity, research collaboration and financial resources of competitors can be drawn out. Sometimes certain companies do unethical practice and enter at back door of competitor’s premises to unveil confidential information, this is very serious concern but most of companies do not pursue that practice. Conclusively, using IP ethically as a tool of CI, pharmaceutical company can look global scenario of pharmaceutical word and can attend higher growth. Information and technology oriented word could develop higher technology for searching, collecting and analysis of patent databases and IP knowledge. Development of super computers which automatically search and analyze information is highly awaited and could make whole process easy and more accurate.pharmaceutical formulation and its research invasis play important role in the young generation of the pharmacy students because without seeing the process we don’t know about the formulation and development of any medicine because of that a industrial visit should be compulsory to all the pharmacy students.

Acknowledgement The authors would like to acknowledge the assistance provided by Supervisor Dr. D.K SANGHI and Co- supervisor Rakesh Tiwle and kind cooperation by Secretary Shri Keshavrao Mankar Bhavabhuti Shikshan Sanstha “Shri Laxmanrao Mankar Institute of Pharmacy” Amagoan, Gondia Maharashtra, INDIA.

REFERENCE 1. Global pharma outlooks-2015, Express pharma-2011. expresspharmaonline.com 2. Global pharma and Biotech M&A report-2012, An IMAP industry reports-2012. imap.com. 3. 2012 profile: Pharmaceutical industry. PhRMA report-2012. phrma.com. 4. Andrew M. Lacy. Analyzing competition in pharmaceutical  industry. Economic committee newsletters, 10 (1),  2008. 5. Competition and regulation issues in pharmaceutical industry. OECD-2000, oesd.org 6. Pharmaceutical competitive intelligence for the regulatory  affairs professional. Terkko Navigator-2012. terkko.helsinki.fi. 7. Pallavi Mahajan. Advent of intellectual property rights in the pharmaceutical industry. Social science research network, 1820627, 2011 8. Gillian Chaloner-Larsson, Ph.D, GCL Bioconsult, Ottawa.  A WHO guide to good  manufacturing practice (GMP) requirements Part 2: Validation.

REFERENCE ID: PHARMATUTOR-ART-2012

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Pharmaceutical industry visit: a mesmerizing reflection of academic knowledge towards the industrial playground of applications

Industrial visit is a part of a college curriculum, seen more often in a pharmacy course, during which students visit companies and get insight regarding the internal working environment of a company and how a company functions, as well as useful information related to the practical aspects of the educational course which cannot be visualized in lectures. The industrial visit is considered one of the most tactical methods of teaching. It provides students with an opportunity to learn practically through interaction, working methods and employment practices. Visiting a company gives students a practical perspective on the world of work; it gives them exposure to current work practices as opposed to possibly theoretical knowledge being taught at college. Industry visits are relevant to media students too. A visit to a green research domain in a drug discovery company makes understanding concepts easier. Keywords: Competitive intelligence, Intellectual property rights, Research and Development, Good Manufacturing Practice, World Health Organization, Food and Drug Administration, Quality Assurance, Quality Control, Abbreviated New Drug Application, New Chemical Entity, Quality by Design

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Pharma Students Industrial Training Report on Helios Pharmaceuticals pdf

Table of Contents

Report on Industrial Visit to Helios Pharmaceuticals pdf

In the topic “Pharma Students Industrial Training Report on Helios Pharmaceuticals” we cover all the aspects of a Pharma unit Such as the Tablet Section, Liquid Section, Capsule Section, Packing Section, QA & QC Section. We think that this material will help you to create your Industrial Training Report. you can download Pharma Students Industrial Training Report on Helios Pharmaceuticals pdf file by clicking on the link given bellow

Helios Pharmaceuticals Company Profile

 A stringent quality control (chemical and instrumental analyst)is being maintained under the highly qualified and experienced team

 Analyzing the manufacturing process from raw material procurement through all operations up to final packing.

 Self-reliance displayed by the production of 70% of bulk drugs required and almost the entire

 Formulations requirement within the country.

 Thrust on improving healthcare delivery as well as pharmaceutical manufacturing infrastructure by many state governments.

 Growth in opportunities for medical tourism

 Low-cost production and R&D

 Highly skilled workforce with significant expertise in chemical synthesis World-class facilities at national laboratories specializing in process and cost-effective technology development

 Increasing international trade in the pharmaceuticals sector

 Cost-effective source for generic drugs, especially, for those going off patent

 A separate QA team handles all in-process quality controls.

» To be a world-class manufacturer of Injectable & sensitive products like Clavulanic Acid.

» To establish world-class Research & Development infrastructure for new products & Drug delivery systems.

» To be a world-class player in Clinical Research & Toxicology.

» To develop a highly motivated & empowered team of professionals and their continuous development.

» To see Brooks as an Institution for ethical & respectable world-class Pharmaceutical company.

RESEARCH & DEVELOPMENT

We understand that Pharmaceuticals being a knowledge-based industry, Research and Development is the most important and valuable tool for the foundation upon which any company’s growth is based.

We have focused on developing a world-class team to develop new molecules in injectable and clavulanic acid-based products supported by Sophisticated Infrastructure for Research & Development. In this facility, we are housing 25 scientists and research scholars.

This team is working on the development of the latest broad-spectrum antibiotics and other latest molecules Regular Research & Development, stability analysis, impurity isolation, and characterization of molecules are carried out on a regular basis. The center is supported by high-tech instruments like HPLC, UV-spectrophotometer, stability chambers, Lyophilizes, osmolality meter, GC, etc.

Our team is putting regular and best efforts into discovering new safe and logical routes in developing and stabilizing new molecules. Process development is done in the best possible ways. Contract research is the latest wing in development.

Manufacturing

Brooks manufactures standardized herbal ingredients for many countries around the world. We have our own manufacturing facility that boasts an annual herb extraction capacity of 1500 tons and is a certified 100% Export Oriented Unit (EOU).

Brooks has a well-structured extraction procedure that is documented in detail, automated, monitored at every stage, and executed to precision. Every aspect of manufacturing is performed in accordance with current Good Manufacturing Practices (cGMP) guidelines by experienced and trained personnel and is validated by Standard Operating Procedures (SOPs).

The extraction process is carried out at pre-determined conditions using multi-purpose counter-current extraction assemblies. Various modern techniques like pressure extraction, continuous solvent extraction, soxhlet extraction, etc. are also implemented. Purification of the phyto-compounds is done by column chromatographic techniques, differential fractionation, and crystallization. The final extracts are then spray-dried or vacuum dried.

This modern and state-of-the-art plant is located in an excise-free zone, where special tax advantages are bestowed by the center government like 100% excise exemption and a lower rate of cst@1%. This state-of-the-art plant is spread over more than 5000 sq. meters of land, surrounded by the lush green environment with pollution-free surroundings of Himachal. This facility is having well-garnished & well-maintained lawns and greenery to add to the healthy ecosystem of Himachal Pradesh.

BROOKS HAS THREE SECTIONS:

A) BETA-LACTAM SECTION

B) CEPHALOSPORINS SECTION

C) GENERAL SECTION

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