VALIDATION VS QUALIFICATION

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Here are the differences between qualification and validation in a simplified Hinglish language:

Definition:

Qualification: Iska matlab hai ki machines aur systems ko check karna hai ki woh specifications ke according set up kiye gaye hai aur sahi tarah se kaam kar rahe hai.

Validation: Iska matlab hai ki processes aur products ka check karna hai ki woh consistent quality produce kar rahe hai aur standards ko meet kar rahe hai.

Scope:

Qualification: Yeh manufacturing mein use hone wali machines aur systems se related hai, jaise production equipment, utilities, aur facilities.

Validation: Yeh manufacturing processes aur products se related hai, jaise manufacturing processes, analytical methods, aur cleaning processes.

Purpose:

Qualification: Iska purpose hai ki machines aur systems ko production mein use se pehle sahi tarah se set up aur functioning kiya jaye.

Validation: Iska purpose hai ki processes aur products ki quality consistent ho aur standards ko development aur production ke time frame mein meet kiya jaye.

Timeline:

Qualification: Yeh process typically new equipment ya system ke installation aur commissioning phase mein kiya jata hai.

Validation: Yeh ek ongoing process hai jo product ki development aur production ke time frame mein hota hai.

Documentation:

Qualification: Ismein equipment ya system ke specifications, installation aur testing results ki documentation ki jarurat hoti hai.

Validation: Ismein process ya product ke development, testing, aur ongoing monitoring ki documentation ki jarurat hoti hai, taaki consistent quality ka assurance ho sake.

Regulatory requirements:

Qualification: Regulatory agencies dwara iska requirement hota hai taaki machines aur systems kuch standards aur specifications ko meet kare.

Validation: Regulatory agencies dwara iska requirement hota hai taaki processes aur products kuch quality standards ko meet kare aur safe ho use ke liye.

Toh is tarah se, qualification machines aur systems ko check karta hai, jabki validation processes aur products ko check karta hai, taaki woh standards ko meet kar sake aur safe ho use ke liye.

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