SOP for 5 S in pharma
1.0 Objective
To save the valuable time and save the wastages.
2.0 Scope
This SOP applies to all employees (management & worker staff also) in abc company.
3.0 Responsibility
3.1 All Supervisor of HR & Administration
3.2 Manager/ Head Concern Area
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
HR : Human Resource
CC NO : Change Control Number
cGMP : Current Good Manufacturing Practice
HOD : Head of Department
5.0 Procedure
5.1 Meaning of 5s
5.1.1 Sort : Clearing the work area.
5.1.2 Set in Order : Designating location
5.1.3 Shine : Cleanliness & workplace appearance
5.1.4 Standardize : Everyone doing things the same way
5.1.5 Sustain : Ingraining the 5S’s into the culture.
5.2 Explain
5.2.1 Sort: Clearing the work area
Any work area should only have the items needed to perform the work in the area. All other
items should be cleared (sorted out) from the work area.
5.2.2 Set in Order: Designating location
Everything in the work area should have a place and everything should be in its place.
5.2.3 Shine: Cleanliness & workplace appearance
Not only should the work area be clear, it should also be clean. Cleanliness involves housekeeping
efforts, improving the appearance of the work area, and even more importantly, preventive
housekeeping – keeping the work area from getting dirty, rather than just cleaning it up after it becomes dirty.
5.2.4 Standardize: Everyone doing things the same way
Everyone in the work area and in the organization must be involved in the 5S effort,
creating best practices and then getting everyone to “copy” those best practices the same way,
everywhere, and every time. Work area layouts and storage techniques should be standardized wherever possible.
5.2.5 Sustain: Ingraining the 5S’s into the culture
It’s tough to keep a 5S effort, or any improvement effort for that matter, going.
The 5S’s involve a culture change. And to achieve a culture change, it has to be ingrained into
the organization – by everyone at all levels in the organization.
6.0 Forms and Records
6.1 None.
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Quality Assurance, Personnel & Administration, Production.
8.0 History
| Revision Number | Details For Change |
Reason for Revision |
| 00 | New SOP | NA |
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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