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 |
- process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System
sop for Storage of Standard Weights
-
process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System
sop for Storage of Standard Weights
sop for Verification of Weighing Balance
-
Sop for Submitting of Leave Application
sop for Accident Management Procedures
sop for Accident Management Procedures
Cleaning and colour coding of Factory Apparel (Clothes)
Job Responsibilities of Key Personnel
sop for Maintenance of Building
Destruction of Batch Production and Control Records BPCR
Procedure for Sampling of Rinse water Swab
Cleaning Validation of Equipment
Measurement and Recording of Temperature and Relative Humid
Sampling of Product at Intermediate Stages
Approval of Overprinting on Packing Material
sop for Procedure for Reprocessing
Issuance and Destruction of Executed Documents