what is validation , validation protocol and validation
master plan?
Answer / anandpcp
validation :Action of proving and documenting that any
process, procedure or method actually leads to the
expected results
VP : The VP is a written plan stating how validation will be
conducted, including test parameters,
product characteristics, production equipment and decision
points on what constitutes
acceptable test results.
V M P :VMP is a high level document that establishes an
umbrella validation plan for the entire project
and summarizes the manufacturer’s overall philosophy and
approach, to be used for
establishing performance adequacy. It provides information
on the manufacturer’s validation
work programme and defines details of and time-scales for
the validation work to be
performed, including stating the responsibilities relating
to the plan.
| Is This Answer Correct ? | 26 Yes | 2 No |
What are closely monitor parameters in stability study?
How we fix the validity period of a Normal solution and re-standardization due date
What is the difference between Drug Purity and Drug Potency?
why some samples are taking 500mg for water content and some samples are taken 2g for water content?
what are the role of MR
What is the difference of vacuum pressure and vapor pressure?
How can I differentiate between OOS, change control and deviation
1 Answers Dr Reddys, IPCA, Orchid, Orion Laboratories, Zydus Cadila,
Describe iso 9001 for pharmaceutical?
Can any deviation be changed into the change control?
Which will give more drug release paddle or basket in dissolution?
2 Answers Aishwarya Healthcare,
What is disintegration time for dispersible tablets?
In Stability testing if significant change occurs then what will be the action plan