Protocol VS SOP ( Hold time study )

What is the difference between SOP and protocol?
What kind of things need to be added in protocol?
For example:- if it’s a hold time study protocol for a product ( Saline)
In that protocol do I have to mention the procedure of finding TAMC , filtration and the pathogen part in detailed.
Like from sampling to testing and the observation.

1 Like

Hi Mikry, I hope I can address your questions correctly; I will assume examples specific for Validation (given the hold time study you mentioned as example):

In short, a Validation SOP provides general guidelines for validation activities, ensuring consistency and standardization in procedures, while the Validation Protocol is a specific plan for a particular validation study, outlining the detailed steps, criteria, and requirements for that specific process, such as a hold time study. Therefore, it is not necessary to include, in this case, the procedure for finding TAMC, filtration and pathogen part in detailed if this is already specified in different or separate SOPs.

A general description of both can be like this:

  1. Validation SOP (Standard Operating Procedure):
  • Definition: Outlines the standard steps and procedures to be followed during a particular operation or process.
  • Purpose: Provide a set of standardized instructions and guidelines for the execution of validation activities. These procedures ensure consistency and repeatability in the validation process.
  • Content: SOP for validation like a hold time study would typically include general procedures, responsibilities of personnel, equipment requirements, sampling methods, testing criteria, and any other relevant details for conducting the hold time study.
  • Application: The SOP is a practical guide for day-to-day operations and serves as a reference for personnel involved in the validation process. It establishes a standardized approach to conducting validations.
  1. Validation Protocol:
  • Definition: A Validation Protocol is a detailed plan or document that outlines the specific steps, conditions, and criteria for the validation process. It is a more specific and structured document compared to an SOP.
  • Purpose: The Validation Protocol serves as a blueprint for the validation study. It defines the scope, objectives, acceptance criteria, test methods, and any other critical information necessary for the successful completion of the validation.
  • Content: In the context of a hold time study, a Validation Protocol might include details such as the purpose of the study, the equipment to be used, sampling plans, testing procedures, acceptance criteria for the study, and a schedule of activities.
  • Application: The Validation Protocol is a pre-approved plan that guides the execution of the validation study. It is reviewed and approved by relevant stakeholders before the validation activities commence.

I hope this summary is helpful

1 Like

Dear Andmentor,
I now have a better understanding on this .thanks a lot !!! :grinning::grinning::grinning: