difference between temporary change control and deviation
- 4 Answers
- 22465 Views
- Flamingo Pharmaceuticals, XYZ, I also Faced
- E-Mail Answers
Answer Posted / manusb07
Temporary change control and deviation
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.
or we cannot follow (planned) the approved procedure to p
| Is This Answer Correct ? | 3 Yes | 1 No |
Post New Answer View All Answers
Discuss the legal and regulatory considerations surrounding the prescription of Alprazolam, including scheduling and documentation requirements.
In dissolution test why sample is withdrawn from top of the paddle and not less than 1 cm away from wall?
How to check the integrity of Sieve, Screen, FBD Bag?
What exepients are used in dry powder injections?
i've completed B.Pharmacy in nov.2009 & now i want to apply for drug inspector,but i don't know about the eligibility ,procedure to apply ,entrance test,interviews,etc. so i want a detailed information about it.please send me the information.thanks
What skills would you look for while hiring a pharmaceutical representative?
What should be the minimum limit of a working standard?
Discuss the potential side effects and risks associated with Alprazolam usage. How would you manage or mitigate these side effects in a patient?
Dear friens,this is sreedhar i am a pharmacy post graduate and having 3 years of experience in pharma industry. I am searching job in USA. through that i want to apply H1,please sugeest me how can i search job or is there any consultancies in india help me to get job?
What do you mean by Q+5 in dissolution?
what is recovery factor
when will andhara pradesh government announces drug inspector posts and when will be the exam conducted? please inform me..
Which instrument used fbd fingerbag pore size identify purpose
Describe iso 9001 for pharmaceutical?
Can you explain the pharmacological mechanism of Alprazolam and how it interacts with the central nervous system?
