Good Manufacturing Practice Report: Assessment 2 - 96057, Production

This report presents an analysis of Good Manufacturing Practice (GMP) within a chemical-based medicinal production company. It begins with an executive summary highlighting the importance of GMP in ensuring product quality and customer satisfaction. The report then defines GMP, emphasizing the need for adherence to legal and quality assurance standards, particularly within the pharmaceutical industry. The core of the report focuses on the implementation of GMP, proposing specific practices such as refresher training for employees, rigorous product testing, detailed record-keeping, equipment cleanliness, and adherence to qualification documentation. A questionnaire was conducted to assess current practices, revealing a need for improvement. The analysis of the feedback shows a strong willingness among the company's workers to adopt these practices. The conclusion reinforces the essential nature of GMP, asserting that its implementation will improve the company's operations and reliability. The report provides references to support the claims and findings. The assignment is a response to a scenario where the production supervisor has been part of an inspection by the TGA and has to address deficiencies in GMP compliance. The report proposes corrective and preventive actions to rectify the identified issues. The report also includes a rubric to assess the criteria for the report.

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Good manufacturing practice
by [name]
Course
Professor’s Name
Institution
Location of Institution
Date

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Executive summary
Production of goods involves the creation of products and or increasing their
usefulness. It may be through manufacturing or processing. The production process ensures the
supply of goods to the market. However, the produced products must be of high quality for
customer satisfaction. The production team must, therefore, ensure there is the observance of the
good manufacturing practice. The manufacturing practices are discussed bellow following a
given case study. In this report, the company's good manufacturing practice is presented, and the
plan to implement it in a chemical-based production medicinal company.
Contents

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Executive summary.........................................................................................................................2
Good manufacturing practice..........................................................................................................3
Implementation of good manufacturing practice.............................................................................3
Proposed good manufacturing practices..........................................................................................4
Questionnaire...................................................................................................................................5
Feedback and analysis discussion....................................................................................................6
Analysis...........................................................................................................................................7
Conclusion.......................................................................................................................................7
References........................................................................................................................................7
Good manufacturing practice
In every production, most probably medicinal producing companies need a lot of
carefulness in the operations. The company has to stick to the legal formalities of the government

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(Rossi et al., 2019.p.113). For quality assurance, the government has unique companies that aid
in inspection of the production companies to ensure all goods are vetted before they are sold to
the customers. However, the company's top management team may require the protocol to be
embraced in the production and release of the products. Some of the departments may not adhere
to the stipulated steps of releasing the product to the market. It is due to the reluctance of the
management team. The company has to release only vetted goods to the market, and therefore
and inspection investigation of the cause of the restrictions is done to ensure there are quality
management systems. It is a report analyzing the findings of the limits that the manufacturing
department should obey.
Implementation of good manufacturing practice
Under the help of the management team, it is very crucial to exercise good manufacturing
practices. These practices are ensured by subjecting all the workers to programs that activate
their knowledge of production. The production data is very crucial, and even they will be able to
prepare production resource tools with ease. Out of my research, I have noticed that the company
has not been following the best production practices (Zhu et al., 2018.p.211). The exercises
should be implemented as soon as possible with the authority of the company manager.
Proposed good manufacturing practices
The following practices should be embraced during production. Every company has to
assure both the government and the consumers that the products are genuine and, therefore,
cannot harm the customers (Pachler et al., 2017.p.462). Like our company has a significant
production ideal of medicine and other medicinal drugs. The company needs close supervision
and monitoring of the activities. It also requires great concern and accuracy in production (Guess
et al., 2017.p.1170). The company, which recklessly produces medicinal drugs carelessly, may

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not meet the requirements if the market, and therefore if failed, the drugs can be harmful to the
users and even the environment.
The company needs to stop reestablish the refresher proper manufacturing practice
training. The training will ensure all the manufacturers are equipped with the knowledge
necessary to meet customer satisfaction and be honest in production practices. The company has
to facilitate the process every three months so that the customers may get reliable services.
Secondly, the company should not sell any product before it is sampled and tested for
vulnerability. The testing of the samples is aimed to determine the effects of the product on the
market. And even to the environment.
Thirdly, there should be daily record keeping of the bill of materials and all the
measurements used in mixing raw materials (Grau-Vorster et al., 2019.p.484). The importance of
keeping these raw materials ratio records is to ensure there is reference information Incase of any
risk occurring from the same product.
The production equipment should be kept clean every time to avoid contamination. Such
material includes the mixing tanks and all other production vessels.
The company should ensure all the academic qualification documents for all operators are
kept for reference. For those employed under excellent performance should, therefore, provide
their qualification evidence for company legal formalities.
Before the packaging of any product, the company should ensure there is clearance from
the health ministry, and all records should be kept for quality control purposes. The measures are
very crucial since drugs can be of high risk to workers and even to the producers and consumers
(Laronda et al., 2017.p.295). The purpose of following good manufacturing practices is to ensure

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that no inconveniences during production. And the reliability of the customers and the
government is promoted.
The following evidence through research and analysis was done to ensure that the above
claim is valid. Therefore, the company needs to work upon the required prototype to ensure there
is Harmon in its operations. All the workers were subjected to the following survey, and they
gave feedback, which they responded positively and with sincerity (Blackford et al., 2019.p.126).
The company research and quality analysis control department has had issued the following
online questionnaire to all the workers and the related personnel. To ensure there is quality data
collection.
Questionnaire
Q1. Have you been exposed to the fresher proper manufacturing training for the last three years?
Respondent choices tick where necessary (a). yes (b) No
Q2. Did the manufacturers wash the mixing tanks frequently after use?
Answer if it is related to your department or you have knowledge about it.
Respondent choices tick where necessary (a). yes (b) No
Q3. Did you keep the bill of materials records? And is the system of record-keeping appropriate?
Respondent choices tick where necessary (a). yes (b) No
Q4. Are good manufacturing practices essential to keep in your company?
Respondent choices tick where necessary (a). yes (b) No

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Q5. Following the above question four, do you suggest to embark to the excellent manufacturing
practice observation with immediate effect?
Respondent choices tick where necessary (a). yes (b) No
Feedback and analysis discussion
Participants 7000
Question Choice (a) Choice (b)
Q1 0 7000
Q2 0 7000
Q3 0 7000
Q4 7000 0
Q5 7000 0
Analysis
Following the feedback, after analyzing the information, it was found that the company
requires establishing the new system of embracing good manufacturing practices to avoid
making mistakes during operations (Adiga et al., 2018.p.679). The company does not need to
force the workers as they are readily willing to participate and provide their records of academic
qualifications as soon as they are requested to do so.

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Conclusion
Good manufacturing practice is essential, and following this procedure, the company will
be a better place. The company is now fully willing to establish an operating system that will
ensure all the workers adhere to the order of production.

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References
Adiga, R., Al-Adhami, M., Andar, A., Borhani, S., Brown, S., Burgenson, D., Cooper, M. A.,
Deldari, S., Frey, D. D. & Ge, X. 2018. Point-of-care production of therapeutic proteins
of good-manufacturing-practice quality. Nature biomedical engineering, 2, 675-686.
Blackford, S. J., Ng, S. S., Segal, J. M., King, A. J., Austin, A. L., Kent, D., Moore, J., Sheldon,
M., Ilic, D. & Dhawan, A. 2019. Validation of current good manufacturing practice
compliant human pluripotent stem cell‐derived hepatocytes for cell‐based therapy. Stem
cells translational medicine, 8, 124-137.
Grau-Vorster, M., Rodríguez, L., Del Mazo-Barbara, A., Mirabel, C., Blanco, M., Codinach, M.,
Gómez, S. G., Querol, S., García-López, J. & Vives, J. 2019. Compliance with Good
Manufacturing Practice in the Assessment of Immunomodulation Potential of Clinical
Grade Multipotent Mesenchymal Stromal Cells Derived from Wharton’s Jelly. Cells, 8,
484.
Guess, A. J., Daneault, B., Wang, R., Bradbury, H., La Perle, K. M., Fitch, J., Hedrick, S. L.,
Hamelberg, E., Astbury, C. & White, P. 2017. Safety profile of good manufacturing
practice manufactured interferon γ‐primed mesenchymal stem/stromal cells for clinical
trials. Stem cells translational medicine, 6, 1868-1879.
Laronda, M. M., Mckinnon, K. E., Ting, A. Y., Le Fever, A. V., Zelinski, M. B. & Woodruff, T.
K. 2017. Good manufacturing practice requirements for the production of tissue
vitrification and warming and recovery kits for clinical research. Journal of assisted
reproduction and genetics, 34, 291-300.
Pachler, K., Lener, T., Streif, D., Dunai, Z. A., Desgeorges, A., Feichtner, M., Öller, M.,
Schallmoser, K., Rohde, E. & Gimona, M. 2017. A Good Manufacturing Practice–grade

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standard protocol for exclusively human mesenchymal stromal cell–derived extracellular
vesicles. Cytotherapy, 19, 458-472.
Rossi, E. M., Scapin, D., Rosanelli, M. L., Honorato, J. F. B. & Kochhann, L. M. 2019.
Microbiological Evaluation of Artisanal Food Quality and of Good Manufacturing
Practice in Agroindustries of the Far West Region of Santa Catarina, Southern Brazil.
International Journal of Microbiology and Biotechnology, 4, 113.
Zhu, J., Reynolds, J., Garcia, T., Cifuentes, H., Chew, S., Zeng, X. & Lamba, D. A. 2018.
Generation of Transplantable Retinal Photoreceptors from a Current Good Manufacturing
Practice‐Manufactured Human Induced Pluripotent Stem Cell Line. Stem cells
translational medicine, 7, 210-219.