How can I differentiate between OOS, change control and deviation
- 1 Answers
- 5973 Views
- Dr Reddys, IPCA, Orchid, Orion Laboratories, Zydus Cadila, I also Faced
- E-Mail Answers
Answer Posted / kartik renalson
OOS stands for out of spcification , it means when product/intermidiate/raw material is manufactured and tested for the defined specification and result obtained for any of the specification does not complies, it is reffereed as OOS.
change control is the document raised it require to change in existing parameter. Change in process or process modification, change of equipment/eqyipment position, change of oganogram etc. change can be anything including man, method, methodology, machine.
deviation referes to the non compliance of any of the activity/operation as per predefned process/ SOP.
| Is This Answer Correct ? | 24 Yes | 0 No |
Post New Answer View All Answers
What is the difference between polarimeter lamp and IR lamp?
What is the difference between sonication and homozinization?
What is the difference between uniformity of content and content uniformity as official test for all tablets?
Describe iso 9001 for pharmaceutical?
How related substance method is developed for new compound which is not official in the pharmacopeia?
plzzz..send me the pevious papers of drug inspector for uppsc....i.l b highly oblige
When we change water of Hygrometer?
What is column efficiency and performance ? And how can we know the column is better?
Why and When RRF is necessary in RS method? How it is helpful in method development?
how impurity is analyzed in a tablet
Why we use potassium hydrogen pthalate for determination of calibration in Total organic carbon
How to conduct Literature Survey for Generics Development for European Market
What should be the minimum limit of a working standard?
what is antioxidant para meters
What exepients are used in dry powder injections?
