sop for Specimen Signatures
1.0 Objective
1.1 To lay down a procedure for Specimen Signature of employees.
2.0 Scope
2.1 This Standard Operating Procedure is applicable for Specimen Signature of all new recruit to be
followed at formulation plant of abc Pvt. Ltd.
3.0 Responsibility
3.1 Officer / Executive QA shall be responsible for taking the Specimen signature of staff on
standard form.
3.2 Head -Quality Assurance or his/ her designee shall be responsible for compliance of SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
No. : Number
Specimen Signature : Specimen signature is a signature to proof authenticity of a person who
is signing the document. Signature shall provide the documentary evidence for signing the
documents. Specimen signature shall also provide a traceability of the document signed by particular employee.
5.0 Procedure
5.1 Specimen signature of every employee who is responsible to sign off the controlled document
shall be maintained by QA department.
5.2 QA Officer / Executive shall be responsible for taking the specimen signature of employee
at the time of joining & update in the month January of every year and fill the record
of employee as per Annexure-1.
5.3 Whenever a new recruit joins the company, then after completion of induction
training, QA Officer/ Executive shall take his / her Specimen signature.
5.4 After giving the specimen signature, new recruit shall proceed for routine work.
5.5 Specimen signature contains the two signature i.e. one is short form signature and other
is full form signature of the employee.
5.6 Record of specimen signature shall be maintained by QA documentation cell, when need
arise for verification of signature, same shall be verified from QA documentation cell.
5.7 Employee shall not change the specimen signature during the signing of documents.
5.8 After revision of specimen signature record, the previous version shall be
destroyed by QA Officer/ Executive.
5.9 When any employee resign or transfer to other location then, QA Officer / Executive shall
write the “Resign” or “Transfer” in remark column.
6.0 Forms and Records
6.1 Specimen signature record Annexure- 1
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Quality Assurance, Production, Warehouse, Quality Control, Engineering, HR.
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
Preparation and Control of Master Batch Production and Control record
Issuance and Retrieval of Control documents
Calibration Policy for equipment
procedure for batch numbering system for products
sop for Handling of Incident during operation
Procedure for Allocation of Numbers for Machine Equipment