Answer / srinivas

Its contains all information of your product.Likestability
or any one at which condition sample kept at temperature,
tests required, sample quanity, time period,
specifications, raw material sorces, pacaking materials
etc...

Answer / tn rao

protocol is nothing but 'a document which contains a
detailed or full information about specific system or a
method'.
Ex: we are preparing a protocol for a method, it contains
the method related specification, STP, raw material source,
required chemicals, column & dimentions, method type,
sample quantity, acceptance criteria etc..............

Answer / ramesh babu

Simply Protocal is nothing but detailed plan of work to
perform the validation. Before performing the validations
we need to have the plan how to do, what kind of perameters
we need to perform and what kind of materials we need to
use etc.. all should mention in protocals. There will be
different protocols, depends up on the tasks.

Answer / a.narayana

Protocol means pre-planning report of the proposed
activities of execution.

Example: If plan for Process validation, we need to have a
plan to conduct the validation.
For this, we have write a full document, objective of the
validation, responsibilities, Starting materials and
related approved source deatils and analytical spec and
methods, In-process, Finished product spec and method,
Batch selection, Process BPR's and critical parameters and
formats for recording the results.

Another Example: In general, we plan for construct a house,
for this, we need to have a plan.
In this plan, firat we need a vacant site, approval,
material requirements, required amount, mason, wood work,
floor work, paintings, etc., If required amount, we need to
go for loan and related procedure ..

Answer / pratibha malviya

Protocol is nothing but afull scheme/plan written document
about specific study like validation, stability study
etc.It should prepared before starting study and it should
be approved by concerned authorities.It contains all plan
regarding that study from starting to end.

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