SOP for Authorized Signatory

      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

  This procedure applies to the manufacturing facility.

    3.0 RESPONSIBILITY

  All Department Heads 

  4.0 ACCOUNTABILITY

  Technical - Director 

  5.0 PROCEDURE

  Quality assurance system related documentation should be signed by “Technical Director”.

  Other all department documentation should be signed by “GM/DGM/Asst. Manager –QA & RA”.

  Organization authorized only blue pen and IPQA use only green pen.

  “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. Specimen signature      list of authorised signatory in the prescribed form is to be maintained in QA as per          Annexure – I.

  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.

      Each department has to maintain their authorised signatory list for their records in the            format given below.

     Specimen signature list of technical staff in the prescribed form is to be maintained in           QA as per Annexure – II.

     Quality assurance has to maintain a authorised signatory list for all the below listed                master documents but not limited to Master formula record.

  Batch manufacturing and packaging record.

  Standard operating procedures.

  Validation protocols.

  Product release standards.

  QC specifications.

  Analytical testing methods

 Review the list of authorised signatory regularly as new employees are hired and responsibilities changes.

 6.0  ABBREVIATIONS

  SOP - Standard Operating Procedure

  QA - Quality Assurance

  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