Can anyone provide me a detail stability study protocol templet for new product please?
Sorry if I come off rude, but since this is your first post I will state this.
No one will do your work for you. If you ask questions about your current format or what you plan on including in your protocols others can give suggestions.
Very good point Seal, posts like this as you can see will not get a good response from the community.
[quote=seal]Sorry if I come off rude, but since this is your first post I will state this.
No one will do your work for you. If you ask questions about your current format or what you plan on including in your protocols others can give suggestions.[/quote]
I appreciate your striaght forward reply Seal and you were not rude. I failed to convey my intentions.
My sincere apologies to everyone.
Since I am new to documentation I had limited idea of what should be included in the protocol. I intend to have a universal stability protocol for all dosage (solid , liquid and semi solid) form which may include
- Scope
- Purpose
- Resposibilities
- Sampling plan
- Interventions
- deviations
- Analysis Reports
- Conclusion
Could you be kind enough to let me know if I can include these points or I need to include some more points.
I sincerely request you to pardon me for my trivial knowledge in documentation.
I think you are off to a good start. I am not sure what information you plan on including in the scope or other sections but you should detail the product, the formula used (e.g. batch record info, batches sizes), packaging configurations (e.g. packaging material, count/quantities), time and temperature intervals and setpoints, what method you are using to test, the acceptance criteria.
Dear Seal
Thank you very much for your directions. I will definately include the points you have mentioned.