CHAPTER 14

Good Manufacturing Practices

14.1 WHAT ARE GOOD MANUFACTURING PRACTICES? (GMP)

In simple words, good manufacturing practice (GMP) is a concept that ensures products are consistently produced and controlled according to quality standards. It is designed to minimize risks to patients being treated with the medicine.

The World Health Organization (WHO) defines GMP as follows:

‘GMP is that part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization or product specification.

GMP is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the ...

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