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
- 168337 Views
- Biocon, Cipla, DRL, Glenmark, Granules, Lupin, Micro Labs, Mylan, Natco, Ranbaxy, Swissmedic, I also Faced
- E-Mail Answers
Answer Posted / r. venugopala reddy
Deviation are two types. 1. Unplanned deviation and
2.Planned deviation. Deviation shall be raised to the
unplanned deviations and immediate action shall be taken to
the deviations but Planned deviations are temporary change
controls that means we can raise the temporary change
control instead of planned deviations.
Suppose we depatured the approved procedures or system, such
cases we can raise the deviation. In case we will departure
the approved procedures or systems as per our requirement
i.e. either customer requirements or yield/quality
requirements,such cases we can raise change control.
| Is This Answer Correct ? | 6 Yes | 1 No |
Post New Answer View All Answers
What are the filing requirements for ANDA-USA, Europe, Brazil, South Africa, Japan and Emerging Markets
What is the basic requirement for preparing drug master file , like EDMF , USDMF ?
What are the regulatory commitments in markets like USA, Canada, Europe, Brazil, South Africa and Japan
what is the leak test procedure of filled bottles (liquid)
Caffeine standard is recommended by the monograph for HPLC wavelength accuracy calibration. It is covered range of 205 to 273 only.If the method have wavelength beyond the range, then how it supports for instrument performance?
what is ur strengths and weekness in ur professional life as medical rep?
WHAT IS MEANING OF DEAIATION WITH EXAMPLE
Iam a B.PHARMA GRADUATE from DELHI UNIVERSITY and I am looking forward for DRUG INSPECTOR EXAM..kindly mail me any ques papaers reg the same...
please explain the job responsibilities of quality assurance..
what is your experience in medical continuing education.
Tell us about your oncology experience.
Anyone have any idea when to conduct Uniformity of Weight (UOW) and when need to conduct Uniformity of Dosage Units (UOD) or when need both? I read BP it only said if average weight < or = 0.04g then just conduct UOD, no need UOW. Under UOD section, it doesnt say when need to conduct UOD but just said UOD got two type, one is Mass Variation (MV), another is Content Uniformity (CU) and under what conditions to conduct them. For USP, no UOW section, only got UOD section.
What is the role of buffers (ex: KH2PO4) in HPLC analysis,
What do you mean by GTT? What are the effect of GTT on film coating.
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?
