Essays on Bio Pharmaceutical Plant Design and Manufacturing Principles Coursework

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The paper "Bio-Pharmaceutical Plant Design and Manufacturing Principles " is an outstanding example of finance and accounting coursework.   The standards and requirements for APIs within the context of new drug application are described in this paper. The importance of the guidelines about the processes regarding the manufacture of drugs along with biologic APIs is underlined. This includes veterinary products also. The procedures and infrastructure needed for chemical isolation and purification processes for APIs are examined. The discussion and the analysis in this paper are regarding the needs of present good manufacturing practices.

The important practices will be about processing, packing and holding. The storage place for the pharmaceutical ingredients is important in the construction of the facility regarding it. The manufacturing principles should be according to the Good manufacturing principles regulations. These are framed for finished pharmaceutical products. The identification of the CGMP guidelines for the manufacturing of APIs is important. These must reflect in the clinical trials also. This is important for a company that have processing units for DNA vaccines. The useful engineering and construction activities for the processing activities in the plant are discussed.

The various steps taken from the initial to the final purification stages are identified. The construction needs of those requirements are identified and analysed. Avoiding adulteration is an important concept in the manufacturing pharmaceutical processes. The standards maintained in the facility should avoid adulteration. For this adherence to the strict principles are necessary. The practices that are capable of bringing a positive effect on the quality and purity of the APIs are considered can be good management practices. Strict adherence to CGMPs while producing the APIs is needed.

The principles about processing controls, sampling and testing need documentation. Necessities in a biopharmaceutical manufacturing Facility Construction requirements Design and Construction Different facilities are required to create flow for the raw materials, intermediates and APIs in the facility.

References

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1. Draft Guidance, 1998, Guidance for Industry, US department of health and human services, ,electronic, 16-3-07, http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/cber/guidelines.htm

2. Craig Sandstrom , 2007, Case Study for Applying Single Use/ Disposable Technology in Vaccine Manufacturing, Fluor Corp, ,electronic, 17-3-07, http://interphex.conferencepath.com/program/?action=viewday&date=4/24/2007

3. DSM, 2007, DSM Biologics Biopharmaceutical Manufacturing Facility Expansion, Montreal, Canada, pharmaceutical-technology.com, ,electronic, 17-3-07, http://www.pharmaceutical-technology.com/projects/dsm/

4. Celltrion, 2007, Celltrion Biopharmaceutical Plant, Incheon, South Korea, pharmaceutical-technology.com, ,electronic, 17-3-07, http://www.pharmaceutical-technology.com/projects/celtrion/

5. RP news wires, 2007, Pharmaceutical companies look to lean manufacturing, reliable plant, ,electronic, 17-3-07, http://www.reliableplant.com/article.asp?articleid=3599

6. Scott A. Kouri Raymond K. Schneider, 2005, Must-haves vs. nice-to-haves: Selecting the right cleanroom construction materials, portafab, ,electronic, 17-3-07, http://www.portafab.com/cleanroom_construction_article1.html

7. ICH Steering Committee, 2000, GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS, ICH, ,electronic, 18-3-07

8. National bio informatic centre, 2007, National Biomanufacturing Centre, Speke, United Kingdom, pharmaceutical-technology.com, ,electronic, 18-3-07, http://images.google.co.in/imgres?imgurl=http://www.pharmaceutical-technology.com/projects/biomanufacturing/images/NBC-7s.gif&imgrefurl=http://www.pharmaceutical-technology.com/projects/biomanufacturing/&h=125&w=150&sz=7&hl=en&start=11&tbnid=YjaR7SgtfZClZM:&tbnh=80&tbnw=96&prev=/images%3Fq%3Dlay%2Bout%2Bbiopharmaceutical%2Bmanufacturing%2Bfacility%26svnum%3D10%26hl%3Den%26sa%3DN

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