Difference between Change control and Deviation please give the answer elaborately
Change control: It is a documented procedure wherein we can make changes in an approved procedure, process, equipment, method for better improvement without impacting the product quality and before implementing such changes, approval of Quality unit must be needed.All the changes made through change control procedures are PERMANENT, they are not TEMPORARY.
Deviation: There are two types of deviations Unplanned: It is the situation where we did not follow the written procedure which is against cGMP. in such cases a deviation is need to be filed and investigation must be done and accordingly CAPA must be taken. Planned: It is the situation where we can not follow the written procedure due to technical problem and we must deviate the procedure to process further. such planned deviation must be minor in nature and are for TEMPORARY only. Before making any planned deviation, Impact assessment shall be done. If we want to make such changes permanent then change control procedure must be used.
| Is This Answer Correct ? | 0 Yes | 0 No |
What is difference between Analytical method validation and Analytical method transfer?
What is the role of Pharma QA and Validation Tester - Referring to jobs as Computer system validation analyst - interview quetions.
What are your duties in your current position?
pls send me last two years solved papers of health & malaria inspector to kumar.santosh087@yahoo.com
How do you feel about physical restraints?
How to register or submit drug master file to any regulatory agency?
What is difference between Warm and Lukewarm Water as per pharmacopia.
What is the role of buffers (ex: KH2PO4) in HPLC analysis,
concomitant administration of 6-mercaptopurine and which product results in severe bonemarrow suppression?
plz.mail me model papers of drug inspector of chhattisgarh..or MP.if Posible. Mail Id-recha_1428@rediffmail.com...mrs_1428@rediffmail.com,
How to set impurity limits for Related substances test.
please e-mail me the model of Tamil Nadu drug inspector question papers