A.R. Numbering System
1.0 Objective
To lay down the procedure for analytical report (AR) numbering system.
2.0 Scope
This procedure is applicable for A.R. Numbering System at abc Pvt. Ltd.
3.0 Responsibility
3.1 Executive – Quality Control.
3.2 In charge/Head-Quality Control.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QC : Quality Control
CC NO : Change Control Number
cGMP : Current Good Manufacturing Practice
G : General
5.0 Procedure
5.1 A.R. Numbering System For abc Drugs Products
5.1.1 The following system is used to allot for Tables, Capsules, External Preparation and Liquid.
5.1.2 It contains Alphanumeric Eight digits i.e. XX-13001
5.1.3 First two Alphabetic digits (XX) represent the Dosage form and Stage, refers as table 1 blow.
5.1.4 Three digit having “-” desh to separate the Alphabetic and Numeric digit.
5.1.5 Fourth and fifth numeric digits having “08” represent the year 2008.
5.1.6 Last three Numeric digits Show the serial number of the A.R. Number of each Dosage form i.e. 001, 002, 003………..999.
Table 1
| Sr. No. | Dosage Form | Alphabetic Code | Numeric Code | ||
| Bulk | Semi Finish | Finished | |||
| 1. | Tablet | BT | IT | FT | 13001 |
| 2. | Capsule | BC | IC | FC | 13001 |
| 3. | External Preparation | BE | — | FE | 13001 |
| 4. | Liquid | BL | — | FL | 13001 |
- R. Numbering System For Badrivas Nutraceutical Products
- The following system is used to allot for Tables and Capsules.
- It contains Alphanumeric Nine digits i.e. XXX-13001
- First three Alphabetic digits (XXX) represent the Dosage form and Stage, refers as table 1 blow.
- Fourth digit having “-” desh to separate the Alphabetic and Numeric digit.
- Fifth and Sixth numeric digits having “08” represent the year 2008.
- Last three Numeric digits Show the serial number of the A.R. Number of each Dosage form i.e. 001, 002, 003………………..999.
Table 1
| Sr. No. | Dosage Form | Alphabetic Code | Numeric Code | ||
| Bulk | Semi Finish | Finished | |||
| 1 | Tablet | FBT | FIT | FFT | 13001 |
| 2 | Capsule | FBC | FIC | FFC | 13001 |
A.R. Numbering System For Raw materials
5.3.1 A.R. Numbering system is BRM13-0001
BRM represent for abc Raw Material.
“08” represent the year 2008
0001 represent the Analytical Report Number 0001, 0002, 0003………………9999
5.4 A.R. Numbering System For Packing materials
5.4.1 A.R. Numbering system is BPM13-0001
BPM represent for abc Packing Material.
“13” represent the year 2013
0001 represent the Analytical Report Number 0001, 0002, 0003………………9999
5.5 A.R. Numbering System For Water
5.5.1 A.R. Numbering system is PW13-0001
PW represent for Purified Water.
“08” represent the year 2008
0001 represent the Analytical Report Number. i.e. 0001, 0002, 0003………………9999
5.6 A.R. Numbering System For ETP
5.6.1 A.R. Numbering system is ETP13-0001
ETP represent for Effluent Treatment plant.
“08” represent the year 2008
0001 represent the Analytical Report Number. i.e. 0001, 0002, 0003………………9999
5.7 A. R. Numbering System For Rinse Water Analysis
5.7.1 A.R. Numbering system is RW13-0001
RW represent for Rinse Water
“08” represent the year 2008
0001 represent the Analytical Report Number. i.e. 0001, 0002, 0003………………9999
5.8 A.R. Numbering System for Other Parties.
5.8.1 The following system is used to allot for Tables, Capsules, External Preparation and Liquid.
5.8.2 It contains Alphanumeric Nine digits i.e. XXX-13001
5.8.3 First three Alphabetic digits (XXX) represent the Dosage form and Stage, refers as table 1 blow.
5.8.4 Fourth digit having “-” desh to separate the Alphabetic and Numeric digit.
5.8.5 Fifth and Sixth numeric digits having “08” represent the year 2008.
5.8.6 Last three Numeric digits Show the serial number of the A.R. Number of each Dosage form i.e. 001, 002, 003………..999.
Table-1
| Sr. No. | Dosage Form | Alphabetic Code | Numeric Code | ||
| Bulk | Semi Finish | Finished | |||
| 1. | Tablet | TBT | TIT | TFT | 13001 |
| 2. | Capsule | TBC | TIC | TFC | 13001 |
| 3. | External Preparation | TBE | — | TFE | 13001 |
| 4. | Liquid | TBL | — | TFL | 13001 |
5.9 A.R. Numbering System For Nutraceutical Products of Other Party
5.9.1 The following system is used to allot for Tables and Capsules.
5.9.2 It contains Alphanumeric Ten digits i.e. XXXX-13001
5.9.3 First Four Alphabetic digits (XXX) represent the Dosage form and Stage, refers as table 1 blow.
5.9.4 Fifth digit having “-” desh to separate the Alphabetic and Numeric digit.
5.9.5 Sixth and Seven numeric digits having “08” represent the year 2008.
5.9.6 Last three Numeric digits Show the serial number of the A.R. Number of each Dosage form i.e. 001, 002, 003………………..999.
Table 1
| Sr. No. | Dosage Form | Alphabetic Code | Numeric Code | ||
| Bulk | Semi Finish | Finished | |||
| 1 | Tablet | TFBT | TFIT | TFFT | 13001 |
| 2 | Capsule | TFBC | TFIC | TFFC | 13001 |
5.10 A.R. Numbering System of Microbiology Section
5.10.1 The following system is used to allot for Tables, Capsules, External Preparation and Liquid.
5.10.2 It contains Alphanumeric Nine digits i.e. XXX-13001
5.10.3 First three alphabetic digits (XXX) represent the Section, Dosage form and Stage, refers as table 1 blow.
5.10.4 Fourth digit having “-” desh to separate the Alphabetic and Numeric digit.
5.10.5 Fifth and Sixth numeric digits having “08” represent the year 2008.
5.10.6 Last three Numeric digits Show the serial number of the A.R. Number of each Dosage form i.e. 001, 002, 003………..999.
For Example
AR Number is MRM13-001
M Represent- Microsection
RM Represent- Raw Materials
08 represent- Year of Manufacturing 2008
001 Represent – Analytical Report Number
5.11 For Raw Material
A.R. Numbering system is MRM13-0001
MRM represent for Microbiological testing of Raw Material.
“08” represent the year 2008
01 resent the Analytical Report Number 0001, 0002, 0003………………9999
5.12 A.R. Numbering System For Water
A.R. Numbering system is MPW13-0001
MPW represent for Microbiological testing of Purified Water.
“08” represent the year 2008
001 represents the Analytical Report Number. i.e. 001, 002, 003………………999
5.13 A.R. Numbering System For ETP
A.R. Numbering system is METP13-0001
METP represent for Microbiological testing of Effluent Treatment plant.
“08” represent the year 2008
0001 represent the Analytical Report Number. i.e. 0001, 0002, 0003………………9999
6.0 Forms and Records
6.1 None.
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Assurance, Quality Control
8.0 History
| Revision Number | Details For Change |
Reason for Revision |
| 00 | New SOP | NA |
Operating Procedure of Centrifuge
sop for preparation and storage of reagent solution
sop for Calibration and Maintenance of Laboratory Instruments and Equipment
Disposal of Residual Sample or Left Over Material
sop for for Laboratory Incident
standard operating procedure temperature monitoring
sop for operation of infrared moisture balance
sop for preparation of mobile phase
sop for Preparation and Issuance of Analysis protocol standard
sop of placebo and impurity stock solutions
sop for disposal of residual sample
sop for handling of pharmacopoeial changes
sop for procedure for operation of ultrasonic cleaner
difference between UPLC and HPLC
sop for for Emergency Eyewash and Shower
sop for operation and calibration of total organic carbon analyzers
sop for operation of cobb tester
sop for Operation and calibration of atomic absorption spectrophotometer
sop for Operation and calibration of gas liquid chromatograph
sop for operation of humidity oven
sop for operation and calibration of serological water bath
sop for monitoring of drain trap
sop for destruction of analytical samples after testing and control samples
sop for destruction of used chemicals
Sop for Operation of suction pump
sop for Operation and calibration uv cabinet
sop for Operation and calibration of bulk density apparatus
sop for operation and calibration of shore hardness tester
sop for operation of rub proofness tester
sop for monitoring of purified water
sop for Retesting of packaging materials
sop for Retesting and resampling of raw materials
sop for Control of issuance of record of analysis green sheets
sop for Control of computer passwords
sop for sampling of packaging materials PM
Operation and Calibration Procedure for pH Meter
Calibration of Melting Point Apparatus
Procedure For HPLC column washing procedure
Procedure For Retest Period of Raw Material
Procedure For Training Programme For Quality Control Personnel
Standard Operating Procedure is to provide guidelines for Preparation
Procedure For Analysis of Water rinsing
Procedure For Calibration of Glassware
Procedure For Procurement and storage of reference standards
Procedure For Preparation of buffer solution