SOP for Authorized Signatory

1. OBJECTIVE
To provide a procedure for filling of authorized signature cards

2. SCOPE
It is Applicable in all departments

3. RESPONSIBILITY
• Department head
• Technical- director

4. SAFETY INSTRUCTIONS
• N/A

5. PROCEDURE
5.1 Quality assurance system related documentation should be signed by “Technical Director”.
5.2 Other all department documentation should be signed by “GM/DGM/Asst. Manager –QA & RA”.
5.3 Organization authorized only blue pen and IPQA use only green pen.
5.4 “Authorized Person” means that any person signing the documents should have sufficient knowledge, training and expertise to adequately review and approve data, information conclusions and recommendations contained therein.
5.5 Specimen signature list of authorized signatory in the prescribed form is to be maintained in QA record.
5.6 Each person who signs documents in production, QC, QA, Warehouse, Commercial, Human resource management, IT / ERP, Engineering and Safety health & environment must sign in the authorized signatory list.
5.7 Each department has to maintain their authorized signatory list for their records in the format given below.
5.8 Specimen signature list of technical staff in the prescribed form is to be maintained in QA record.
5.9 Quality assurance has to maintain an authorized signatory list for all the below listed master documents but not limited to
5.9.1 Master formula record.
5.9.2 Batch manufacturing and packaging record.
5.9.3 Standard operating procedures.
5.9.4 Validation protocols.
5.9.5 Product release standards.
5.9.6 QC specifications.
5.9.7 Analytical testing methods.
5.10 Review the list of authorized signatory regularly as new employees are hired and responsibilities changes.

6. RELATED DOCUMENTS
Format Signatory List – Annex-I

7. DISTRIBUTION INDEX

8. ABBREVIATIONS
QA Quality Control department
RA Regulatory affairs
QC Quality Control
IPQA Inprocess Quality assurance
GM General Manager
DGM Deputy General Manager

9. REVISION HISTORY