Instrument Numbering, Purpose:
Instrument Numbering, To provide a system for allocating identification number to Laboratory instrument in order to have better traceability and reference in all related documents.
Instrument Numbering, Scope:
This SOP is applicable to all Laboratory instruments and equipment’s installed in quality control laboratory, microbiology laboratory, product development laboratory and IPC laboratory of General block and Sterile block at XX Pharmaceuticals Ltd.
Definitions / Abbreviation:
[][]SOP: Standard Operating Procedure.
Responsibilities:
[][]The roles and responsibility is as follows:
Concerned Personnel
[][]He / she shall be responsible for assigning / allocating the sequential number to all equipment / instrument.
Quality Assurance Personnel
[][]He / she shall be responsible for effective implementation and monitoring of procedure.
Manager, Quality Assurance
[][]To ensure effective implementation of SOP.
[][]To approve the document.
Procedure:
[][]Numbering for Individual Laboratory Instrument:
[][]Each individual Laboratory instrument shall be assigned on unique identification number.
[][]Concerned department shall assign the sequential number to all instruments at the time of Installation Qualification and record the details in respective department register as per Annexure-II.
[][]Do not repeat the same number to another instrument.
[][]Give identification no. to all instruments as XXX/YY/000.
Where,
=>XXX corresponds to three alphabets denoting the area code of the Laboratory.
=>YY corresponds to two alphabets denoting the instrument name as per approved list available in Annexure-I.
=>000 corresponds to three numerical figures starting from 001 denoting the number of instrument in continuous manner.
=>As per Example of Balance GQC/BA/030
Where,
=>GQC = Corresponds to three alphabets denoting the Area code of Quality Control Laboratory at General Block.
=>BA = Corresponds to two alphabets denoting the instruments code.
=>030 = Number of instruments in continuous manner.
The Area Code for each Laboratory is given below:
Area Description/ Area Code
[][]Quality Control Laboratory (General Block)/ GQC
[][]Quality Control Laboratory (Sterile Block)/ CQC
[][]In-Process Laboratory (General Block)/ GIP
[][]In-Process Laboratory (Sterile Block)/ CIP
[][]Product development Laboratory (General Block)/ GPD
[][]Product development Laboratory (Sterile Block)/ CPD
[][]Microbiology (General Block)/ GMB
[][]Microbiology (Sterile Block)/ CMB
[][]Quality Assurance will prepare the Master list of Laboratory instrument with identification number and get it approved by Manager, Quality Assurance as per Annexure-III.
[][]Update the list and approve it whenever require and give serial number to list prepared.
[][]All instruments will be tagged containing instrument name and Identification number (Bold Type). Format of instruments identification tag is as follows:
INSTRUMENT / DEVICE
Name:
ID Number:
[][]In case of advent of new type of instruments, there is an option for extending Annexure-I by hand writing of Manager, Quality assurance with signature and date without reviewing the whole SOP.
[][]For this, the respective department will inform to it to the Quality Assurance Department for new code number.
[][]The new instrument (Handwritten by Manager, Quality Assurance) will be included in SOP during the next version.
Annexure:
Annexure-I: Code number for Laboratory Instrument.
Annexure-II: Laboratory Instrument Register.
Annexure-III: Master List of Laboratory Instrument