Coursework Assignment Question

As a Quality Assurance (QA) Officer in a pharmaceutical distribution company, you have received three (3) visual audit findings from a recent internal audit. Your company’s management has requested a written report to assess the issues, evaluate the risks, align each with Good Distribution Practice regulatory expectations and propose Corrective and Preventive Action (CAPA) plan for each of the audit finding.

Audit Finding #1

Figure 1 show a line chart depicting the internal van temperature across a 24-hour delivery route for a cold chain medicine. The acceptable transportation temperature is between 2–8°C for the cold-chain medicine.

Figure 1

Audit Finding #2

Figure 2 shows a checklist that was used at a warehouse during the inbound operation of a consignment of a batch of pharmaceutical product.

Figure 2

Audit Finding #3

Figure 3 shows a security camera view of a warehouse, with an open inventory system on a computer screen.

Figure 3

Report Task & Structure (Max 1,500 words)

Your report should contain the following:

1. Executive Summary
   Summarise the three audit findings, overall risks, and the need for immediate Corrective and preventive actions.
2. Introduction to Good Documentation Practices (GDP)
   Briefly explain the purpose and importance of GDP in pharmaceutical supply chains. Include key sources (WHO GDP, HSA Guidelines, PIC/S etc).
3. Analysis of each audit finding
   For each scenario:
   • Describe the non-compliance based on the figure shown
   • Identify key risks and potential consequences
   • Align with relevant GDP regulatory expectations
4. CAPA Plan (for each audit finding)
5. Implementation & Monitoring Strategy
   Explain how the CAPAs will be rolled out and monitored
6. Conclusion
7. References

As a general guideline, the assignment should be typed in Arial font style with a 12-point font size, 2 cm margins, and a minimum of 1.5 line spacing. You should ensure that only relevant references or citations are included in your answers to each of the question.

References to resources should also be included where appropriate. These will be taken into consideration during the awarding of marks for the assignment.

Referencing Guide

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/guide_to_citing_internet_sourc.html
[Accessed 17 March 2005].

Note: Be careful citing information from WWW sites; most are not peer-reviewed and there is no guarantee that the information is correct

Citing a book as reference

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