PIC/S GMP Guide Part - I for Medicinal Products

TELUGU GMP December 16, 2020

PIC/S GMP Guide Part - I Basic Requirements for Medicinal Products:

PIC/S GMP Guide Part I for Medicinal Products, PRINCIPLE The holder of a Manufacturing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation or Clinical Trial Authorisation, as appropriate, and do not place patients at risk due to inadequate safety, quality or efficacy.

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TABLE OF CONTENT

CHAPTER 1 - PHARMACEUTICAL QUALITY SYSTEM

CHAPTER 2 - PERSONNEL

CHAPTER 3 - PREMISES AND EQUIPMENT

CHAPTER 4 - DOCUMENTATION

CHAPTER 5 - PRODUCTION

CHAPTER 6 - QUALITY CONTROL

CHAPTER 7 - OUTSOURCED ACTIVITIES

CHAPTER 8 - COMPLAINTS AND PRODUCT RECALL

CHAPTER 9 - SELF INSPECTION


PIC/S GMP Guide Part I for Medicinal Products:

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