Interested to Buy Any Domain ? << Click Here >> for more details...
difference between temporary change control and deviation
- 4 Answers
- 24609 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
How to measure each & every tablets hardness in compaction force control system of compression machine?
Imagine a patient expresses a strong preference for Alprazolam due to its rapid onset of action. How would you address their request while considering their overall well-being?
what is limit of cleaning validation
HI, I srinivas , was shortlisted for interview of Ph.D. PROGRAMMES FOR ACADEMIC SESSION 2012, I have interview on 17-nov-2011. Sir can you tell me about interview, how to prepare for it. How it will be? It's my first interview sir, i don't know how to face it. Kindly help me sir, Thanking yoU,
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
pharmacovigilance opportunities in Hyderabad
Why should we not dispatch the reprocess material to export?
Why we use 10 tablets for the analysis of cu test?
How would you manage your team for pahrmaceutical representatives?
how to calculate the potency of gentamycin sulfate
What are the advantages and disadvantages of working for a small & big pharmaceutical company?
at what interval Ukrainian audit will come once you register your product??
How to select temperature of ODT in disintegration test
i like to know when is drug inspector exam 2009.and plz send me da question paper, interviev questions,and other details on my mail.id. shubhg2009@gmail.com. plz
What is the difference between Deviation and Out of Specification?
