A2369C cGMP Compliance Assignment: Internal Audit CAPA Report for Quality Issues in Pharmaceutical Manufacturing

Graded Assignment

There is ONE (1) COMPULSORY question for this graded assignment. You must adhere to the word limits indicated for the question as required. Words more than the stipulated word limit will not be taken into consideration even if the correct answer is contained therein

Question (Total: 30 marks)

You are newly hired as a Quality Compliance Officer at a pharmaceutical company that has recently undergone a series of minor non-conformities flagged during an internal audit. Refer to the pictures below to find out what the audit reveals:

Figure 1

Figure 2

Figure 3

Task:

Write a report to your supervisor outlining your action plan and recommendations. Your report should cover the following:

1. Introduction to the role of a Quality Compliance Officer in upholding cGMP standards. (4 marks)
2. Identification of 3 key issues observed during the internal audit (documentation, training, data integrity) and justify them. (3 marks)
3. Proposed 2 corrective and preventive actions (CAPA) for each of the issues. (6 marks)
4. 2 strategies to strengthen the company’s compliance culture, including training approaches, regular audits, and staff engagement. (6 marks)
5. Reflection on the importance of data integrity and how ALCOA+ principles apply in this context. (5 marks)
6. Referencing (3 marks)
7. Formatting (3 marks)

Use diagrams, tables or flowcharts where relevant to support your report. Cite at least three references to support your recommendations.

(Word limit: 1000 words)

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

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.

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].

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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