Interested to Buy Any Domain ? << Click Here >> for more details...
what is the diffirence between deviation and change control?
at what situations we can raise the deviation and change
control
- 31 Answers
- 167938 Views
- Biocon, Cipla, DRL, Glenmark, Granules, Lupin, Micro Labs, Mylan, Natco, Ranbaxy, Swissmedic, I also Faced
- E-Mail Answers
Answer Posted / arvind mishra
A process that ensures that changes to materials, methods,
equipment and software are properly documented, validated,
approved and traceable.The process includes evaluation to
determine whether validation is required and the level of
validation required.
Deviation is a process in which we have to perform a task
that is not mentioned in the SOP,deviations are two types
one is planned deviation and
another is un planned deviation. Planned deviations are two
types one is tempery and another is permenent. tempery
deviations are approved by QA (for a limited period) then
proceed. permanent deviations are must be reviewed by
releated departments and approved by QA through change
control procedure.
Conclusion;- When deviation is permanent then approved by QA
through change control procedure.
| Is This Answer Correct ? | 0 Yes | 0 No |
Post New Answer View All Answers
What is the basic requirement for preparing drug master file , like EDMF , USDMF ?
what is your experience in medical continuing education.
what is meant by artwork review and handling procedure with an example?
how many clauses are there in iso? give me the clauses details?
what is factor?
difference between RF and correction factor?
What are your intentions towards the uplift of the hospital.
What is difference between Warm and Lukewarm Water as per pharmacopia.
What are the filing requirements for ANDA-USA, Europe, Brazil, South Africa, Japan and Emerging Markets
How to preform dissolution profiling
Why SLS used as dissolution medium
why you are become a medical representative
What experience do you have in training?
what is ur strengths and weekness in ur professional life as medical rep?
please e-mail me the model of Tamil Nadu drug inspector question papers
