Interested to Buy Any Domain ? << Click Here >> for more details...
Difference between Change control and Deviation please give the answer elaborately
- 1 Answers
- 2834 Views
- Rakshit Drugs, Smilax, I also Faced
- E-Mail Answers
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 meant by artwork review and handling procedure with an example?
How are you qualified for the position of Assistant Clinical Director?
what is meant by CAPA?what is the source for deviation (unplanned) to occur, though the process developed by standard validation procedures?
3 Answers GSK GlaxoSmithKline,
please e-mail me the model of Tamil Nadu drug inspector question papers
What r the different sop in or plant
what is immunity?
5 Answers GSK GlaxoSmithKline,
What is the role of Pharma QA and Validation Tester - Referring to jobs as Computer system validation analyst - interview quetions.
How can I assign a retest date for solvents e.g. toluene, methanol, etc?
What are your duties in your current position?
WHAT IS MEANING OF DEAIATION WITH EXAMPLE
Why 3 validation batches charge in stability ?is there any specific reason for 3 ?
What is the Difference between Humidity and Relative Humidity ?
Pharmacy 
