SOP for Authorized Signatory : Pharmaceutical Guidelines

SOP for Authorized Signatory

Standard operating procedure for the authorized signatory in the pharmaceutical manufacturing facility.

1.0 OBJECTIVE

To lay down the procedure for filling of the authorized signature card.

2.0 SCOPE

2.1 This procedure applies to the manufacturing facility.

3.0 RESPONSIBILITY

3.1 All Department Heads

4.0 ACCOUNTABILITY

4.1 Technical - Director

5.0 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 authorised signatory in the prescribed form is to be maintained in QA as per Annexure – I.
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 authorised signatory list.
5.7 Each department has to maintain their authorised 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 as per Annexure – II.
5.9 Quality assurance has to maintain a authorised 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 authorised signatory regularly as new employees are hired and responsibilities changes.

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure
6.2 QA - Quality Assurance
6.3 QC - Quality Control


ANNEXURE – I 
LIST OF AUTHORISED SIGNATORY
S.No
Document  Title
Authorised Signatory
Name
Signature
Initials
01







02







03







04







05









ANNEXURE – II
LIST OF TECHNICAL STAFFS SIGNATORY
S.No.
Name of staff
Designation
Department
Signature
Initials









































































































































































View Video Tutorials





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


Click Here

No comments: Read Comment Policy ▼

Post a Comment


Follow Pharmaguideline


CURRENT JOBS

Show All ❭❭Jobs by PharmaJobs

WRITE A POWERFUL CV

Click Here



ADVERTISE HERE


GET APP FOR NEWS UPDATES

Scan to Download

Android App
Android App

Recent Posts