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 experience do you have in training?
Hi Sir?Mam, If i complete SAS CLINICAL in India, can i step forward to USA for job trials? How far is it possible? Am a B.pharm student ,willing to make up my Master's degree too,will this both M.Pharm and SAS help me out to get a job in USA? Please help me out with a good answer.
How can I assign a retest date for solvents e.g. toluene, methanol, etc?
when i come in contact with any metal items or clothes of fur i find myself shock and when run my fingers on fur clothes or matters, i find sparks. Is there any vitiams deffecieny in my body. If so, what i have to do?
Assume that you've been hired for the position. A mother calls and says her child is sick and she needs an appointment this morning. You don't have an open appointment for the morning. What will you do?
why didn't you go back to previous employer after shifting to bangalore?
why an employee go for medical representative instead of quality?
Which types of deviations are followed in pharmaceuial API manufacturing industry?
what is ur strengths and weekness in ur professional life as medical rep?
IF We have to autoclave two chamber of media one having temp 100 c and onather at RT,which one get autoclaved first?
What interests you about the position of Medical Librarian in our company?
Why SLS used as dissolution medium