SOP format and Templates

SOP format and Templates:

There are no government regulatory agencies such as FDA-approved format for an SOP. There are, however, common requirements within the industry and from regulatory agencies that ensure the accountability, traceability, and consistency of these documents. When choosing a format for a procedure, consider the following.

Title:                      

The title contain for what reason SOP is written

The title of the SOP should be appropriate So by reading title person can understand the meaning

Purpose:

A subject under discussion or  an action in course of execution. Why this sop is required is described into the purpose

Scope:

The extent of the area or subject matter that something deals with or to which it is relevant. Where and when it  apply.

Responsibility:

Who is responsible for perform, monitoring and review the activity is described into the responsibility.

Procedure:

Procedure is the instruction given in proper sequence how to perform any activity or prepare document with all detail including safety .it include all information how  to do activity when to perform activity which data should be recorded all should be explain in detail.

Formats:

Where required data are recorded .it may be in form of register, logbook or issued to concern department in form of controlled document.(Example: change control form issue as control document, equipment usage log  for recording of detail where and equipment is used daily is in for of log book.)

Distribution list :

List of department distribution where SOP required.

History of change:

The detail of why and when SOP is revised.

Each SOP contain unique SOP number,  page number , revision number, company name , effective date name and signature of the person who prepared reviewed and approve the SOP. Format should be proper .

Name of company ______________________________________________ Title of the SOP: SOP number:_________  Revision number ________ page .......... of.......... Replaces: Effective date: ________________________

Purpose: Scope: Responsibility: Procedure: Formats: Distribution List: History of change:

Prepared By:                                Checked By:                        Approved By: (Sign and Date)                          (Sign and Date)                       (Sign and Date)

 
Related Article:
Definition of SOP
Objective of preparation of SOP