DEVIATION IN PHARMACEUTICAL COMPANY

Deviation ka matlab hota hai ki koi likhit procedure ya standard operating procedure (SOP) ke khilaaf chalna ek pharmaceutical company mein. Ye kisi bhi manufacturing process ke kisi bhi stage mein ho sakta hai, jaise ki raw material procurement se lekar finished product ki release tak.

Deviation ke prakaar:

Minor Deviation - Agar koi minor deviation likhit procedure se hota hai jo product ki quality ya safety ko influence nahi karta hai, toh use minor deviation kehte hai.

Major Deviation - Agar koi significant deviation likhit procedure se hota hai jo product ki quality ya safety ko influence kar sakta hai, toh use major deviation kehte hai.

Critical Deviation - Agar koi bahut hi serious deviation likhit procedure se hota hai jo product ki quality ya safety ko bahut bada nuksaan pahucha sakta hai, toh use critical deviation kehte hai.

Deviation ka uddeshya:

Deviation ka uddeshya hai ki uska root cause pata lagakar use correct karna.

Deviation ke impact ko product ki quality aur safety pe kam karna.

Regulatory requirements ko comply karna.

Deviation ka upyog:

Manufacturing process ke dauraan deviation human error, equipment malfunction ya environmental factors ke wajah se ho sakta hai.

Quality control process ke dauraan deviation analysis method ke imprecision ya incorrect testing procedures ke wajah se ho sakta hai.

Deviations ko track karna aur unki frequency ko analyze karke future mein hone waale deviations ko prevent karna.

Deviation ki specifications:

Har deviation ko document karna zaroori hai, uska investigation karna aur product ki quality aur safety pe uske impact ko evaluate karna.

Deviation investigation ke dauraan root cause ko identify karna aur use correct karna ki woh future mein na ho.

Deviation report ko Quality Assurance (QA) department review aur approve karna.

Har deviation aur uske corrective actions ko deviation log mein record aur track karna.

Deviations ko unke severity ke hisaab se classify karna aur unke appropriate corrective actions ko lena.

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