Validation /qualification

Quality Assurance
1

Hi all ,
I want to know where can we find the latest updates about validation process and qualification
can you give me a web site or anything else .Thanks in advance .

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Please share the die selection formula during sampling of process validation

3

Please refer following guidelines,

  • Process Validation: General Principles and Practices by USFDA Guidance for industry, January 2011

  • PIC/S GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS
    ANNEXEs (Annexure-15 Qualification and Validation), PE 009-15 of 1st May 2021

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