Can study protocol become part of SOP

Quality Assurance
1

When we perform a scientific study through a study protocol and get a conclusion, the conclusion of that protocol can becomes a part of SOP with reference of that protocol. If yes so please provide any reference no. Or part as per any regularly

2

Yes, this will be acceptable provided the following conditions are met,

-The protocol to carry out scientific study should be designed on some scientific / Regulatory basis.
-Similarly, the Acceptance criteria in the protocol should be based on sound scientific principles or Regulatory requirements or guidelines,

  • The SOP procedure should have some regulatory / GMP/ GXP reference.
    -The data generated while performing the scientific study should be accurate, complete and auditable.
  • The protocol deviations while executing the study should be appropriately addressed with sound justification.

(There is no such Regulatory reference available. However, if you give any specific example then it can be searched.)

3

Is there any SOP procedure for the same

4

There is no specific SOP procedure. Please follow the general guidelines which I have stated in a previous communication.

5

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