Issuance and Destruction of Executed Documents

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3 days ago

Issuance and Destruction of Executed Documents

1.0 Objective
To lay down a procedure for issuance and destruction of executed documents.
2.0 Scope
This Standard Operating Procedure is applicable for issuance and destruction of executed

documents at formulation Plants of abc Pvt. Ltd.
3.0 Responsibility
3.1 Officer / Executive QA shall be responsible for issuance of executed documents.
3.2 Manager QA / his designee shall be responsible for approval of issuance of executed documents.
3.3 Head QA / his designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
BPCR : Batch Production & Control Record
MFR : Master Formula Record
QA : Quality Assurance
No. : Number
5.0 Procedure
5.1 Issuance of Executed Documents:
5.1.1 Officer / Executive QA shall receive the request for required documents in document

issuance requisition form duly signed with reason for requirement (Annexure-1).
5.1.2 Officer / Executive QA shall take the approval from Manager-QA on document issuance requisition form.
5.1.3 Officer / Executive QA shall make relevant entries of document Outward-Inward

Records with signature of recipients (Annexure-2).
5.1.4 Officer / Executive QA shall write detail of document on document issuance requisition form.
5.1.5 Officer / Executive QA shall maintain the record of requisition in a file.
5.1.6 After receiving the issued documents Officer / Executive QA shall make entries

of Document Outward-Inward Records with signature of recipients (Annexure-2).
5.1.7 If issued documents not returned within 10 days, issuing QA Officer / Executive

shall send the reminder to concern person / department.
5.2 Destruction of Executed Documents:
5.2.1 Certificate of Analysis and analytical data shall be destroyed after completion of

period at least one year after it’s expiry of product.
5.2.2 BPCR of the product shall be destroyed after completion of period at least one year after it’s expiry of product.
5.2.3 Environmental monitoring records shall be destroyed after two year.
5.2.4 Calibration records shall be destroyed after next calibration record available.
5.2.5 Equipment log shall be destroyed after one year.
5.2.6 Vendor audit record shall be destroy after three years.
5.2.7 Training records shall be destroyed after resignation of the employee.
5.2.8 Self Inspection reports shall be destroyed after two years.
5.2.9 Promptly remove the documents / records when the designated retention period is reached.
5.2.10 Take the approval for destruction of listed documents / records from Head QA.
5.2.11 After getting approval, send the documents / records in scrap yards.
5.2.12 All the documents shall be destroyed by sreeding machine in presence of QA.
5.2.13 Records shall be maintained in Annexure-3.
6.0 Forms and Records
6.1 Document Issuance Requisition Form – Annexure-1
6.2 Executed Document Issuance & Submission Record – Annexure-2
6.3 Destruction record of executed documents – Annexure-3
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Assurance, Quality Control, Production,
Engineering and Warehouse.
8.0 History

Revision Number	Details For Change	Reason for Revision
00	New SOP	NA

Issuance and Destruction of Executed Documents

Reason for Revision