A VISIT ON PHARMACEUTICAL INDUSTRIAL ORIENTATION
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.
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.
REFERENCE ID: PHARMATUTOR-ART-2012
Pharmaceutical industry in one of the prominent industry though out the globe and further it is in growing phase1, 2, so innovative activities and strategies play important role in the growth of industry2, 3. However the flip side is that, there is stiff competition between companies for same drug molecule, same disease area or for the same treatment3, 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 industry7, 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 out7, 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 5 MANUFACTURING
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.
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.
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).
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
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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