A Case Study of Johnson & Johnson: GMP and Lean Manufacturing

This case study examines Good Manufacturing Processes (GMP) and Lean Manufacturing principles through the lens of Johnson & Johnson. It reviews the function of Quality Assurance (QA), highlighting its role in planning, scheduling, and ensuring product quality through various control measures. The study analyzes FDA warning letters issued to companies like Apotex, Quali Controle, and Reine Lifescience, focusing on issues such as inadequate quality specifications, inappropriate testing methods, and failures in validating analytical methods. The analysis underscores the critical importance of both quality control and quality assurance in maintaining product standards and regulatory compliance within pharmaceutical manufacturing. Desklib provides access to similar case studies and solved assignments for students.

Good Manufacturing Processes and
Lean Manufacturing
(A Case Study of Johnson & Johnson)
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GOOD MANUFACTURING PROCESSES AND LEAN MANUFACTURING
Table of Contents
Introduction................................................................................................................................3
Review of the function of Quality Assurance............................................................................4
FDA Warning Letter..................................................................................................................6
Letter one: Apotex Research Private Limited........................................................................6
Letter two: Quali Controle & Qual-Controle-C.E.Bac..........................................................6
Letter three: Reine Lifescience..............................................................................................6
Conclusion..................................................................................................................................7
References..................................................................................................................................8
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GOOD MANUFACTURING PROCESSES AND LEAN MANUFACTURING
Introduction
Quality control and quality assurance are the two major pillars to determine the
appropriateness of a product before releasing it to the target market. Although both these
terms differ considerably, the entire process revolves around the fact of providing quality
services to the customers in the target market. In this assignment, special concern has been
drawn towards the functioning of Quality assurance, its roles, and facilities. The facilities and
the production process are also provided in this assessment. The later section of the
assessments sheds lights towards the quality maintenance and warning letters provided by
FDA to make the companies follow the culture of quality management within the
organisation.
Thesis Statement: There is no need to consider quality assurance so long as a company has
quality control in place and the product can be tested for any defects/failures during
production and before release to the mark.
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Review of the function of Quality Assurance
Role of QA: Planning and scheduling the time of the production and determining the
sequences in which the product shall be launched are the major aspects of the Quality
Assurance Department in an Organization. Ensuring all the developmental tasks before
releasing the products to the target market through various steps and quality control measure
make the product ideal to use by the customers. Test planning, execution, assurance, and
issue tracking are the major focal steps that are followed by the quality assurance department
of a company (Anholon et al. 2016).
The function of QA: Quality of the products is the major responsibility of the quality
assurance department. Role of QA and their function under the 6 areas of the pharmaceutical
quality system are as discussed below.
Quality system: Without the appropriate quality system, the company shall not be able to
guarantee whether their products are appropriate to use or not. With the acceptance of ISO-
9000 worldwide, the series of quality checking has increased several folds to maintain the
quality of the products in the pharmaceutical industries. In this regards, the major example
can be drawn from, the working culture of Johnson & Johnson, where the company provides
provisional guidelines to the quality control department of the products in the organizational
functioning (Food and Drug Administration 2016).
Facilities and equipment: Location, designing, construction and maintaining the operation
in the product manufacturing is the major role the QA plays to maintain the facilities and
equipment. According to Harris et al. (2016), installation of the equipment with minimum
risk and directions to operate the equipment are the major function that QA provides while
equipment installation and facilitation.
Materials: The major role of the material in the Johnson & Johnson industry is to provide the
users with the best quality products by a combination of the products. Packaging materials,
solvents, gases, reagents, process aids and labeling material are the major materials that are
needed to m, manufacture a complete product (Maskell et al. 2016).
Production: QA plays a significant role in determining the production of the goods and
products to a large extent. In regards to Johnson & Johnson, the production process is done in
several steps so that the quality of the products remains standard and customer satisfaction is
retained by the company (Mullard, 2015).
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GOOD MANUFACTURING PROCESSES AND LEAN MANUFACTURING
Laboratory controls: This is the first and foremost steps that determine the quality of the
products in a target market. Johnson & Johnson use quality products and natural ingredients
to maintain the quality of their products. The major role that QA plays in this is to determine
the efficiency of each of the ingredients used to manufacture the products. GCP and GMP are
highly determined by the QA in the company for each of the products (Nallusamy et al.
2015).
Packaging and labeling: After passing each of the stages of QC, the packaging and
repacking of the products are processed with batch records. Bulk products are recorded by
tracker before labeling. The major function that it plays is that the customers shall be able to
know about the contamination and freshness of the products and the company shall be able to
track whether the materials are delivered properly or not. It plays a key role in ensuring the
superior quality of the products (Piercy and Rich, 2015).
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FDA Warning Letter
Letter one: Apotex Research Private Limited
Year of issue: 18.09.2018
Main problem: The firm failed to investigate unexplained dispensary of a batch or any of its
component to meet the specifications of FDA.
Addressing the issue with QA or without QA: The issue was regarding the quality
specifications of the company, where the company mentioned the testing of the products and
quality were inadequate to launch in the target market. The capsule that the company
manufactured showed 4% deviation from the standard bar produced by FDA for which they
did not pass the product testing process of FDA. As a conclusion, a warning was provided to
the company that if they did not reformulate their products, FDA shall stop their access to
launch any new subsidiaries or supplementary products. As opined by Salonitis et al. (2016),
by managing the packaging and launching process in the company, the company will be able
to reduce this situation in their business process.
Letter two: Quali Controle & Qual-Controle-C.E.Bac
Year of issue: 3.05.18
Main problem: the firm failed to establish and document the accuracy, sensitivity,
specificity, and reproducibility of its test methods
Addressing the issue with QA or without QA: The issue was regarding the inappropriate
and inadequate test method used by the company to produce subsequent facilities to the
customers. The company did not practice drug testing before manufacturing the products.
This led the company to face difficulties in maintaining the appropriate ratio of the materials
as per the norms provided by FDA. The company must test the materials with proper
equipment and testing equipment to minimize this situation in the business process (Wu et al.
2016).
Letter three: Reine Lifescience
Year of issue: 5.09.2018
Main problem: The Company Failed to validate and verify the suitability of analytical
methods.
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GOOD MANUFACTURING PROCESSES AND LEAN MANUFACTURING
Addressing the issue with QA or without QA: The issue was not regarding Quality but the
methods used by the company to produce and, manufacture their products in the business
process. The company must follow the CAPA plans provided by the FDA to follow the
appropriate method in product manufacturing and production process. To reduce this issue,
the company must provide a summary of the production process used to FDA as soon as
possible. According to Wu et al. (2016), it must also provide the details of roles and
regulations of the person who controls the equipment and production process in the company.
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Conclusion
From the above discussion, it can be concluded that quality assurance and quality control are
the two major processes that are needed by a company to maintain the quality of their
products in the target market. In this regard, the function and role provided in the anterior
section of the assessment provide a clear understanding about the importance of the QA
whereas the warning letters provided by FDA to manage the quality of the products in three
different companies provides a better understanding about the importance of maintaining
quality within a product manufacturing company. From the above discussion, it can be
clearly seen that if a company prevails quality control in all its manufacturing process and
analyze the defect while packaging or testing, quality assurance is not needed to check the
quality of the products in the company.
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References
Anholon, R. and Sano, A.T., 2016. Analysis of critical processes in the implementation of
lean manufacturing projects using project management guidelines. The International Journal
of Advanced Manufacturing Technology, 84(9-12), pp.2247-2256.
Barbosa, G.L., Gadelha, F.D.A., Kublik, N., Proctor, A., Reichelm, L., Weissinger, E.,
Wohlleb, G.M. and Halden, R.U., 2015. Comparison of land, water, and energy requirements
of lettuce grown using hydroponic vs. conventional agricultural methods. International
journal of environmental research and public health, 12(6), pp.6879-6891.
Food and Drug Administration, HHS, 2016. Deeming tobacco products to be subject to the
Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and
Tobacco Control Act; restrictions on the sale and distribution of tobacco products and
required warning statements for tobacco products. Final rule. Federal Register, 81(90),
p.28973.
Harris, J.A., Swenson, C.W., Uppal, S., Kamdar, N., Mahnert, N., As-Sanie, S. and Morgan,
D.M., 2016. Practice patterns and postoperative complications before and after US Food and
Drug Administration safety communication on power morcellation. American journal of
obstetrics and gynecology, 214(1), pp.98-e1.
Maskell, B.H., Baggaley, B. and Grasso, L., 2016. Practical lean accounting: a proven
system for measuring and managing the lean enterprise. Productivity Press.
Mullard, A., 2015. 2014 FDA drug approvals.
Nallusamy, S., Dinagaraj, G.B., Balakannan, K. and Satheesh, S., 2015. Sustainable green
lean manufacturing practices in small scale industries-A case study. International Journal of
Applied Engineering Research, 10(62), pp.143-146.
Piercy, N. and Rich, N., 2015. The relationship between lean operations and sustainable
operations. International Journal of Operations & Production Management, 35(2), pp.282-
315.
Salonitis, K., Zeng, B., Mehrabi, H.A. and Jolly, M.R., 2016. The challenges for energy
efficient casting processes.
Wu, P., Nielsen, T.E. and Clausen, M.H., 2016. Small-molecule kinase inhibitors: an analysis
of FDA-approved drugs. Drug Discovery Today, 21(1), pp.5-10.
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