Access to Authorized Persons in Critical Areas
1.0 Objective
To lay down a procedure for access to authorized persons in critical areas.
2.0 Scope
This Standard Operating Procedure is applicable for access to authorized persons in critical
areas like sampling, dispensing, control sample area, stability room, ETP plant, PSG and
Multi-column distillation plant, water system, utility block, service floor, core area of Production,
sterile area and other Critical areas to be followed at formulation plants of abc Pvt. Ltd.
3.0 Responsibility
3.1 Officer / Executive of concern department shall be responsible for preparing authorized person list.
3.2 In-charge of concern department / his designee shall be responsible for checking of authorized persons list.
3.3 Head of concern department / his designee shall be responsible for approval of authorized persons list.
3.4 QA Officer / Executive shall prepare access to authorized person list recommended by the Head of the concern department.
3.5 Head QA / his designee shall be responsible for authorization and compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
ETP : Effluent Treatment Plant
PSG : Pure Steam Generator
QA : Quality Assurance
No. : Number
HOD : Head of Department
5.0 Procedure
5.1 To prevent entry of unauthorized persons in critical areas, all head of the concern department
shall give name of technical staff, technicians, maintenance staff, workers, etc. to QA Department as per Annexure-1.
5.2 QA shall prepare a list i.e. access to authorized persons as recommended by head of the concern
department and shall display the list of access to authorized persons in concerned areas.
5.3 If there is any change in staff either by resign or by transfer to other location or department,
a prior intimation shall be given to QA department to update the list as per Annexure-3.
5.4 Plant Head, QA Head and QA Manager are authorized to enter in any area.
5.5 Head of the concern departments are authorized to enter in critical areas of their own department.
5.6 Microbiologists are authorized to enter in all critical areas for environmental monitoring along with
designated personnel of that department who is authorized to enter in that area.
5.7 Visitors, Vendors and any other personnel are allowed to enter in critical areas only, if they are
accompanied with any of authorized person of that concerned area.
6.0 Forms and Records
6.1 List of Authorized Persons – Annexure-1
6.2 Access to Authorized Persons – Annexure-2
6.3 Change in Authorized Persons – Annexure-3
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – 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
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
Validation and Qualification Facility System and Equipment
In-process Checks During Packing Operation
Operation and Calibration of Leak Test Apparatus
Operation and Calibration of Friability Tester
Access to Authorized Persons in Critical Areas