Procedure for Allocation of Numbers for Machine/Equipment
1.0 Objective
To lay down a procedure for allocation of numbers for Machine / Equipments.
2.0 Scope
This Standard Operating Procedure is applicable for allocation of numbers for
Machine / Equipments (new and existing) installed to be followed at formulation plants of abc Pvt. Ltd.
3.0 Responsibility
3.1 Concern department officer / executive shall be responsible for allocation of numbers for Machine / Equipments.
3.2 Concern department Head / Head QA / his designee shall be responsible for compliance this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
No. : Number
5.0 Procedure
5.1 Allocate identification number to the machine/equipments installed in
different departments as follows
5.1.1 ID/XXX/EQ/ZZZ or ID/XXX/INC/ZZZ
Where, First 2 characters ‘ID’ indicate the Identification
3rd character ‘/’ is separator
4th, 5th, and 6th character ‘XXX’ indicate the concern department
For example, TAC – Tablet and Capsule department
DPI – Dry Powder Injection department
QCM – Quality Control Micro department
QCD – Quality Control Department
QAD – Quality Assurance Department
UTL – Utility Block
LOZ – Lozenges Department
LIQ – Liquid Department
7th and 8th character ‘EQ’ indicate Equipments Or
7th, 8th and 9th character ‘INC’ indicate Instruments
10th, 11th and 12th characters ‘ZZZ’ indicate the serial number i.e. 001.
5.2 For Balance: XXX/BAL/PPP
Where, XXX indicate the concern department
For example, TAC indicate Tablet and Capsule Block
DPI indicate Dry Powder Injection Block
L & L indicate Liquid and Lozenges Block
QCD Quality Control Department
QAD – Quality Assurance Department
BAL indicate Balance
PPP indicate serial number
5.3 If equipment is shifted from one department to another, follow change control procedure
as per SOP No.QA/009 and allocate a new identification number to the equipment.
5.4 Equipment identification number shall remain if equipment is scrapped.
6.0 Forms and Records
6.1 List of Instruments – Annexure 1
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Quality Assurance, Quality Control, Production,
Warehouse, Engineering.
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