Doc. No.
CBTPL/QA/SOP/001
Catalysts Biotechnologies Pvt. Ltd.
Version:2.0
Quality Assurance Department Revision: 01
Revision Date: 20.10.2023
SOP for SOP
Effective Date: 20.11.2023
1. OBJECTIVE
To Lay down a Procedure for Preparation, Approval, Authorization, Control and Revision of
Standard Operation Procedure.
2. SCOPE
This Procedure defines the basic Principles, defines the Responsibilities & lay down the
procedure for Preparing the SOP. This shall be applicable to all the SOP’S.
3. RESPONSIBILITY
Executive - QMS
4. ACCOUNTABILITY
Deputy Manager – QC
5. PROCEDURE
5.1. Prepare the SOP on the approved Format of A4 Sheet/ Paper.
5.2. Prepare the SOP to describe the Operating Procedures and steps.
5.3. Write all the SOP in Unambiguous language, easy to understand and follow.
5.4. Write the SOP under the following Headings –
Objective,
Scope,
Responsibility,
Accountability,
Procedure, and,
Enclosure.
5.5. SOP required are to be designed, prepared, received and distributed with such a care that
it will comply with the relevant parts of the organization as well as available facilities.
5.6. SOP should be approved, signed with an effective date by authorized personnel
nominated by the management.
Particulars Prepared By Reviewed By Approved By
Name Amandeep Manav Prakash Sharma Dr. KVTS Pavan
Designation Executive - QMS Deputy Manager – QC Assistant VP
Doc. No. CBTPL/QA/SOP/001
Catalysts Biotechnologies Pvt. Ltd.
Version:2.0
Quality Assurance Department Revision: 01
Revision Date: 20.10.2023
SOP for SOP
Effective Date: 20.11.2023
5.7. SOP must not be changed, amended or added without MR approval.
5.8. SOP should be regularly reviewed and kept up to date. When a document has been
revised by the team/management, effective date of corrected version is given and previous
suspended SOP should be retained according to the importance and need of system.
5.9. Any alteration made to a document will be signed and dated by all the above persons who
are authorized to do so. The alteration will permit the reading of the original information,
where appropriate, the reason for the alteration will be recorded.
6. ENCLOSURE
6.1. List of SOP – QA/SOP/001/DOC/001
Particulars Prepared By Reviewed By Approved By
Name Amandeep Manav Prakash Sharma Dr. KVTS Pavan
Designation Executive - QMS Deputy Manager – QC Assistant VP
