Cgmp For Pharmaceuticals By Manohar A Potdar Pdf Free
the objective of the gmp quality system should be to ensure that the quality of the final product is maintained throughout the manufacturing process. prof. potdar also points out that the quality management systems should be based on objective and measurable criteria. the process should be capable of being evaluated and improved, and should be geared to meet the needs of the organisation.
prof. potdar states that the adoption of a quality system is only possible when management has a well-defined goal. he also believes that the quality system should be closely connected with the organisation’s philosophy and vision. he believes that the quality system should be based on a set of principles and guidelines.
prof. potdar believes that it is important to ensure that quality is controlled throughout the entire process and that it is the responsibility of the whole organisation, as well as management, to ensure that its goal is met.
in case of pharmaceutical product which are intended to be consumed by human beings, it is necessary to meet the requirements of good manufacturing practice in order to ensure the safety of the product. these products are referred to as pharmaceuticals.
crosby asserts that quality is free. it’s not a gift, but it’s free. what costs money are the un-quality things all the actions that involve not doing jobs right the first time. this statement illustrates why its vital to exercise good manufacturing practice throughout the whole process, to prevent making mistakes and having to pay unexpected expenses to rectify the errors.
as a trainer and consultant for the pharmaceutical industry, prof. potdar says that quality assurance, quality control and good manufacturing practices go hand-in-hand. he also states that everyone involved in the production or distribution of quality pharmaceutical products must be familiar with these three forms in the fullest and true meaning. prof. potdar emphasises that the system must be fully integrated with all aspects of the organisation. he says that the system must be focused on achieving the quality objectives, based on the quality management system and quality specifications, and on the management’s ability to control the quality of the process. the implementation of gmp should only be considered as a result of the quality management system. the quality management system should also be the driving force behind the implementation of gmp, and not vice versa. the ultimate purpose of gmp is to ensure that the quality of the pharmaceutical product is consistent and reliable. prof. potdar explains that gmp is not just a way to monitor the processes that happen at the manufacturing site, it is also a way to monitor the quality of the product after it is manufactured. the professor has spent much of his life studying quality issues, looking for and testing ways to improve quality. prof. potdar says that the system of good manufacturing practice is focused on the continuous improvement of processes and procedures, the transfer of knowledge and the prevention of faults. the last three of these are the three things that should be monitored and evaluated. it is not possible to rely on the regular inspection of the product, but rather its actual quality should be studied. 5ec8ef588b
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