sop for Authorized Signatory
1.0 OBJECTIVE
1.1 The objective of this SOP is to define the requirements for signature authorization for all document (i.e. master batch formula for processing and Packaging record, Batch manufacturing records, Validation protocols, Standard operating procedures, Finished & Intermediate product specifications & Standard testing procedures and Certificate of analysis etc) and specimen signature of employee working in the company.
2.0 SCOPE
2.1 This SOP is applicable for all staff personnel working
3.0 RESPONSIBILITY
3.1 Asst. Officer or above –Quality assurance – Prepare the SOP and follow-up the SOP accordingly.
3.2 Asst. Manager – Quality Assurance-Provide the support to the implementation of SOP and maintained the records.
4.0 ACCOUNTABILITY
4.1 Head – Quality Assurance / Chief Executive Officer
5.0 REFERENCE(S)
5.1 In-House
6.0 PROCEDURE
6.1 All department documents shall be approved by “Head-QA”.
6.2 Organization authorized only Blue ball pen and IPQA use only green ball pen.
6.3 “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.
6.4 Concerned department head shall depute the authorized person for signing different documents.
6.5 Each department has to prepare signature log of personnel for recording of specimen signature and send to the QA department for final authorization.
6.6 Head QA shall authorize for authorization of other department’s signature log.
6.7 Signature log of QA department shall be signed by CEO for authorization.
6.8 Specimen signature list of staff in the prescribed form is to be maintained in QA as per Format
6.9 Addition of employee signature shall be done whenever any new employee join the company and whenever left the company leaving date shall be mentioned in the column of date of leaving.
Note: In the absence of authorized person the document shall be signed by designee of head of department.
8.0 ABBREVIATIONS
SOP : Standard Operating Procedure
IPQA : In Process Quality Assurance
CEO : Chief Executive Officer