A2369C: Paul is currently interested to apply for a job as a Production Technologist in a current Good Manufacturing Practice (cGMP) certified pharmaceutical manufacturing company : Current Good Manufacturing and Laboratory Practices, Assignment, RP

Question 1 

Paul is currently interested to apply for a job as a Production Technologist in a current Good Manufacturing Practice (cGMP) certified pharmaceutical manufacturing company at Tuas with the following job descriptions:

Job Descriptions:

Analyze production processes, identify areas for improvement, and implement strategies to enhance efficiency, reduce waste, and minimize production costs.
Oversee the maintenance and calibration of production equipment and machinery. Coordinate with maintenance technicians to schedule preventive maintenance activities and troubleshoot equipment issues to minimize downtime.
Work closely with quality control and assurance teams to ensure compliance with quality standards and specifications. Conduct inspections, audits, and quality checks on production processes and finished products to identify deviations and implement corrective actions when required.
Maintain accurate records of production activities, equipment maintenance, inventory levels, and quality control procedures.

Question 2

Read the following experiment description of a research project carefully.

Description of Experiment

You want to conduct a research project on the ability of certain plant extracts that can efficiently kill bacteria which causes tuberculosis. You will first obtain the various species of plants and do a solvent extraction to get the extracts. Following that, you will prepare agar plates to culture Mycobacterium tuberculosis. Drop various concentrations of different types of plant extracts onto the plates. You will then incubate for 7 days and determine the effectiveness of the different types of plant extracts in killing Mycobacterium tuberculosis.

Based on the experiment description above, prepare a research proposal using the proper format, proper headings and to include AT LEAST THREE appropriate references for this proposal.

In your research proposal, you need to address the following components in the relevant sections of your research proposal document.

a) Write your project title
b) Write your hypothesis
c) Identify your variables (dependent, independent and 2 control variables).
d) List down two research questions related to this research proposal that you
would like to do literature research on
e) Propose the methodology that you would like to adopt in carrying out your
objective
f) Suggest 3 ways to ensure that your data is reliable and valid
g) References

Question 3

Documentations are of utmost importance in Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) as well as other subsequent widely accepted industry best practices such as Good Distribution Practice and Good Clinical Practice.

a) Identify at least 2 similarities in terms of documentations for GLP and GMP
and elaborate.
b) Identify at least 2 differences in terms of documentations for GLP and GMP
and elaborate.
c) As an auditor from Health Sciences Authority, you are tasked to audit the
production and validation departments in a current Good Manufacturing Practice (cGMP) certified pharmaceutical manufacturing company. Identify
any three critical areas in terms of documentations that you would want to
review for each department and justify why.

4. References

The format of the list of references shall match the style of citing the references. For example, as a numbered sequence or arranged by alphabetical order of the first author’s last name. Other than that, there are many styles of presenting the reference. The students may follow any of the styles adopted in books (in the bibliography section) or the journal papers (in the References section). The requirement is that the information given must be sufficient for accessing the reference material, and this usually needs the last names, the year of publication, title of the article/book, and the volume numbers and page numbers. For online references, the URL must be given with the date accessed.

Two main ways to present journal references

1. Authors’ surnames listed in alphabetical order

Andrews, S.S. 2002. Terrestrial orchids. Cambridge University Press, UK. 222 pp. Wong, T.Y. , Yong, M., and Seet, A.M. 2000. Armillaria nabsona, a new species from western North America. Mycologia 88: 484-491.

Zhang, W. T. 2001. Identification of orchid mycorrhizal fungi by restriction fragment length polymorphisms of ribosomal DNA. Mycoscience 39: 179-183.

2. Using a numbering system in the text with the first paper cited being [1],
next paper [2], and so on. If first paper is cited again, it is still [1]

[1] Wong, T.Y. , Yong, M., and Seet, A.M. 2000. Armillaria nabsona, a new species
from western North America. Mycologia 88: 484-491.
[2] Ang, Y.S. 2002. Morphological characterisation of fungal endophytes from
Spathoglottis plicata. M.Sc. Thesis, National University of Singapore, Singapore.

Citing and referencing electronic sources

Holland, M. 2004. Guide to citing internet sources [online]. Poole, Bournemouth University.

http://www.bournemouth.ac.uk/library/using/quide to citing internet sourc.html  [Accessed 17 March 2005].

Citing a book as reference
N.M. de Roos. (2004). Functional foods, cardiovascular disease and diabetes.
Cambridge England: Woodhead Publishing Limited.

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