Standard Operating Procedure For Sop On Sop

by Pharmadocx Consultants

PURPOSE:  Main objective of making SOP is to ensure that each operation at all the

levels in the plant is being followed as per the documented procedures. Any deviation

with the documented procedures is supposed to be a violation with the standard

procedures.

SCOPE: This procedure applied to the all types of SOP which has been prepared.

RESPONSIBILITY  :  In charge Q. A.

                                         Factory Manager

 PROCEDURE:       

For preparation of SOP’s following point are to be considered:

1)Objective, (2) Responsibility & (3) Procedure.

1.  Objective:

Under this heading mention the purpose of SOP clearly.

2.  Responsibility:

Responsibility with designation of the personnel to be fixed for compliance of procedure that is under whose supervision the operation is to be carried out.  

3.  Procedure:

(1) Give the small title to each SOP at the top.

(2) Mention the date of printing of SOP at the right top corner.

(3) Mention the SOP No. / Doc No. below the date of printing.

(4) Mention the total no. of pages below the SOP No. in sequence.

5) Mention the current revision no. below the page no.

(6) Mention the Step-wise detailed procedure of each operation

(7) Attach relevant format with each SOP for the compliance documentation.

(8) Special precautions if any, to be taken while following the SOP should be marked separately before the end of SOP.

(9) In the end mention the reason of revision of SOP.

(10) All the SOP’s shall be signed in blue ink pen by the personnel responsible for making SOP’s in the respective column with their designation & name in capital.

(11) Mention the effective date in the respective column,.

(12) Mention clearly the policy of making SOP.

(13) Mention the designation of key personnel accountable for the operation.

(14) Once in a year or as needed.

(15) In S.O.P. mentioned what is your supporting document for SOP compliance.

Author: (GM Production)Checked by: (QA Manager)Authorised by: (Director Technical)
Date:Date :Date :

            (Review date on or before 12 months from date of authorization)

Written by Anmol Singh

Anmol Singh Completed his Bachelors in Field of Mechanical and Automation Engineering. He has over 2 Years of experience in field of Pharmaceuticals, Medical Devices, Cosmetics Manufacturing.

11 June 2023

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