I want to write a sop for granulation or tablet press i dont know i should start from where? And i dont have a template
Write all the steps used to form granules.
Like for eet granulation start from Weighing,sieving,mixing,wetting,screening,drying,screening n final mixing.Write all steps in such way that its can easily be followed
For tablet press write all steps how to start machine n compress tabs on it
Sop should include all steps of granulation process? For example granulation process steps should come in BMR or SOP for granulation?
Yes SOp should include all general steps.BMR is specific for product to product mfg.
Thank you so much
Is there any site or refrence to see BMR templates?
Chek list for operators should be provide in SOP or in process steps in BMR?
can search on google
Check list for which purpose?
Chek list that operators should act based on that step by step.
Operators follow BMR during manufacturing of each product.
SOP is general procedure for granulation of all products.But BMr is product specific n operators follow BMR.bcz mixing order,time excipients etc may varry product to product
Sops are prepared in granulation for the equipments used in the process .I think your query was related to this.rest the process of granulation is defined in BMR of all particular products step by step.
I don’t feel you need to have a SOP for granulation. Instead you can have SOP on how your granulator (High shear granulator). You can include complete operating procedure in detail, loading and unloading of blend, about mixing blade and chopper blade, what all the things you need to ensure before starting the equipment, you can also include about pressure pot and various nozzle sizes you have. What are all the parameters you can read from the display and all.
Coming to BMR, you’ll be including all the steps as below
- Blend loading time
- Dry mixing time
- Binder addition(Time)
- Kneading (Time)
You’ll also include mixing blade rpm and chopper speed if used at each stage of granulation. Nozzle size and pressure used for pressure pot. You’ll be giving all the instructions to the operator how to carry the procedure and operator will fill all the information like start time, end time, rpm, time for transferring binder etc.
SOP for granulation procedure is also required.
You may apply this template: