sop for document equipment numbering system

1.0 OBJECTIVE  
1.1 The objective of this SOP is to define the procedure for numbering of documents / existing & new equipment & facilities in different functional areas.
2.0 SCOPE
2.1 This SOP is applicable for numbering of documents/ existing equipments and new equipments & facility in different functional area
3.0 RESPONSIBILITY
3.1 Asst. Officer or above – Quality Assurance: Prepare the SOP and follow up the standard operating procedure accordingly.
3.2 Head – Quality Assurance: Provide the support to the implementation of SOP and maintaining the record.
4.0 ACCOUNTABILITY
4.1 Head – Quality Assurance / Chief Executive Officer
5.0 REFERENCE(S)
5.1 In-House

6.0 PROCEDURE
6.1 All the documents, equipments and facilities shall be given unique number for it’s easy identification and traceability.
6.2 Numbering System for Equipment
CN/XXX/EQP-NNN
Where:
CN = Company name
/ = For Separation
XXX = Department Code e.g., PRD = Production
/ = For Separation
EQP = Equipment
– = For Separation
NNN = Serial Number 001, 002, 003……….etc.
e.g. CN/PRD/EQP-001, CN/QCD/EQP-001
*Note: Initials of equipment may be written in two to four characters.
6.3 Numbering System for Air Handling Unit
CN/XXX/AHU-NNN
Where:
CN = Company name
/ = For Separation
XXX = Department code (PRD = Production, QCD=Quality control)
/ = For Separation
AHU = Initial of Air Handling Unit
– = For Separation
NNN = Serial Number of Air Handling Unit
e.g. CN/PRD/AHU-001, CN/QCD/AHU-001,
6.4 Numbering System for AHU Supply and Return Grill
CN/XXX/YY/AH-NNN /M-NN
Where:
CN = Company name
/ = For Separation
XXX = Department code (PRD = Production, QCD=Quality Control)
/ = For Separation
YY = Area code (BF = Bottle Filling Room, MR= Mixing Room)
/ = For Separation
AH = Initial of Air Handling Unit
– = For Separation
NNN = Serial Number of Air Handling Unit
/ = For Separation
*M = Initial of Supply / Return (e.g. for Supply = S, Return = R)
– = For Separation
NN = Serial Number of Supply Grill / Return Riser
e.g. CN/PRD/BF/AH-001/S-01, CN/PRD/BF/AH-001/R-01
* Note: Initials of area / location may be written in two to three characters.
6.5 Numbering System for Equipment User Requirement Specification (URS)
CN/XXX/URS/YY-NNN
Where:
CN = Company name
/ = For Separation
XXX = Department Code (PRD = Production Department, QCD=Quality control Department)
/ = For Separation
URS = User Requirement Specification
/ = For Separation
*YY = Initial of Equipment Name (e.g. BF = Bottle Filling Machine)
/ = For Separation
NNN = Serial Number 001, 002, 003……….etc.
e.g. URS No.: CN/PRD/URS/BF-001, …….002
*Note: Initials of equipment may be written in two to four characters.
6.6 Numbering System for Qualification Validation Protocol
6.6.1 Numbering System for Equipment Qualification Protocol cum report
CN/XXX/YY/MZZ-NNN-MM
Where:
CN = Company name
/ = For Separation
XXX = Department Code (PRD = Production Department)
/ = For Separation
YY = Initial of Document e.g. DQ, IQ, OQ, PQ
/ = For Separation
M = Initial of Production Line (e.g. Large Volume Parenterals=L,
Small Volume Parenterals = S)
ZZ = Initial of Equipment Name e.g. BF for Bottle Filling Machine
– = For Separation
NNN = Serial Number 001, 002, 003…….etc.
– = For Separation
MM = Revision Number 00, 01, 02…… etc.
The numbering system will be serial wise for each line equipment qualification protocol e.g. CN/PRD/DQ/LBF-001-00, CN/PRD/DQ/SBF/001-00,
CN/PRD/PQ/LBF-001-00 etc.
*Note: Initials of equipment may be written in two to four characters.
6.6.2 Numbering System for General Validation Protocol and Report
6.6.2.1 For Validation Protocol: – CN/XXX/YYP/NNN
Where:
CN = Company name
/ = For Separation
XXX = Department Code (PRD, =Production Department)
/ = For Separation
YYP = Initial of Document (e.g. CVP = Cleaning Validation Protocol,
PVP= Process Validation Protocol,
AVP = Analytical Method Validation Protocol)
/ = For Separation
NNN = Serial Number of Document (e.g. 001, 002, 003………004)
E.g. CN/PRD/CVP/001, CN/PRD/PVP/001 etc.
6.6.2.2 For Validation Report: – CN/XXX/YYR/NNN
Where:
CN = Company name
/ = For Separation
XXX = Department Code (PRD, =Production Department )
/ = For Separation
YYY = Initial of Document (e.g. CVR = Cleaning Validation Report,
PVR= Process, Validation Report,
AVR = Analytical Method Validation Report)
/ = For Separation
NNN = Serial Number of Document (e.g. 001, 002, 003………004)
E.g. CN/PRD/CVR/001, CN/PRD/CVR/001 etc.
6.7 Numbering System for Re-Validation Protocol & Report ( Equipment / System / Process)
6.7.1 For Re-Validation Protocol related with Equipment / System / Process
CN/XXX/RVP/ZZ/NNN-MM
Where:
CN = Company name
/ = For Separation
XXX = Department Code (PRD= Production Department)
/ = For Separation
RVP = Re-validation Protocol
/ = For Separation
*ZZ = Initial of Equipment Name (e.g. BF = Bottle Filling)
/ = For Separation
NNN = Serial Number 001, 002, 003……….etc.
– = For Separation
MM = Revision Number of Document
e.g. CN/PRD/RVP/BF/001-00
*Note: Initials of equipment may be written in two to four characters.
6.7.2 For Re-Validation Report related with Equipment / System / Process
CN = Company name
/ = For Separation
XXX = Department Code (PRD= Production Department)
/ = For Separation
RVR = Re-validation Report
/ = For Separation
*ZZ = Initial of Equipment Name (e.g. BF = Bottle Filling)
/ = For Separation
NNN = Serial Number 001, 002, 003……….etc.
– = For Separation
MM = Revision Number of Document
e.g. CN/PRD/RVR/BF/001-00
*Note: Initials of equipment may be written in two to four characters.
6.8 Numbering System for Master Equipment Index
CN/XXX/IN-NNN
Where:
CN = Company name
/ = For Separation
XXX = Department Code e.g. QAD for Quality Assurance Department
/ = For Separation
IN = Initial of Index
– = For Separation
NNN = Serial Number 001, 002, 003……….etc.
e.g.: CN/QAD/IN-001
6.9 Numbering System for Stability Study Protocol
CN/XXX/ST/YY/NNN
Where:
CN = Company name
/ = For Separation
XXX = Department Code
/ = For Separation
ST = Stability Study Protocol etc
/ = For Separation
YY = Initial of Product Name (e.g. Dextrose 5% = D-5)
– = For Separation
NNN = Serial Number 001, 002, 003……….etc.
– = For Separation
e.g.: CN/QCD/ST/D-5/001
6.10 Numbering System for BMR / BPR
CN/XXX/ZZZ/MM/NNN-MM
Where:
CN = Company name
/ = For Separation
XXX = Department Code Section Code (PRD = Production)
/ = For Separation
ZZZ = BMR / BPR
/ = For Separation
MM = Initial of Product Name (e.g. D5= Dextrose 5%)
/ = For Separation
NNN = BMR/ BPR Serial Number 001, 002, 003……….etc.
MM = Revision no.
e.g.: CN//PRD/BMR/D-5/001-00, CN/PRD/BPR/D5/001-00
* Product code may be written two to four digits
6.11 Numbering System for Flow Chart
6.11.1 Numbering System for Process Flow Chart
CN/XXX/PF/NNN-MM
Where:
CN = Company name
/ = For Separation
XXX = Department Code e.g. QAD for Quality Assurance
/ = For Separation
PF = Process Flow
/ = For Separation
NNN = Serial Number 001, 002, 003……….etc.
– = For Separation
MM = Revision Number of Document
e.g.: CN/QAD/PF/001-00 etc,
6.11.2 Numbering System for Water System Flow Chart
CN/XXX/WS/NNN-MM
Where:
CN = Company name
/ = For Separation
XXX = Department Code e.g. ENG for Engineering Department
/ = For Separation
WS = Water System
/ = For Separation
NNN = Serial Number 001, 002, 003……….etc.
– = For Separation
MM = Revision Numbering System of Document
e.g.: CN/ENG/W/001-00
6.12 Numbering System for Drawing
CN/YYY/DW/ZZ-NN-MM
Where:
CN = Company name
/ = For Separation
YYY = Initial of Drawing Name (e.g. MM= Men Material movement, SZI=System
zoining
/ = For Separation
DW = Drawing
/ = For Separation
ZZ = Initial of Floor (e.g. GF = Ground Floor, FF = First Floor, etc.)
– = For Separation
NN = Drawing Number (01, 02…03 etc).
– = For Separation
MM = Revision Number of Document
e.g.: CN/MM/DW/GF-01-00, CN/P&I/DW/FF-01-00, CN/P&I/DW/SF-001-00
6.13 Prepare the equipment list for all the equipment / instruments as per Format

7.0 ABBREVIATIONS
SOP : Standard Operating Procedure
SOP : Standard Operating Procedure
AHU : Air Handling Unit
8.0 ANNEXURE

Annexure-I

Master Equipment Index