Good Manufacturing Processes and Lean Manufacturing: A Case Study of Johnson & Johnson

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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