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 Heads4.0 ACCOUNTABILITY
4.1 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.
6.2 QA - Quality Assurance
6.3 QC - Quality Control
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 Procedure6.2 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
|
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