Standard Operating Procedure for Instrument Numbering System in Quality Control Laboratory

1. Purpose:

To lay down a procedure for Instrument Numbering System in Quality Control Laboratory.

2. Scope:

The scope of this is applicable for Instrument Numbering System in the pharmaceutical quality control laboratory at [company name].

3. Responsibility:

Quality control person: To assign instrument identification number, to prepare the instrument master list

Quality control supervisor: To verify the assigned instrument identification number

Head Quality control: Effective implementation of SOP

4. Definitions:

Not Applicable

5. Procedure:

5.1 General instructions:

• Each laboratory instrument or equipment must have unique identification number.

• As and when new instrument or equipment is to be procured, User Requirement Specification (URS) to be prepared. Unique identification number shall be allocated before URS preparation and shall be reflected in the URS.

• Proposed unique identification instrument number shall be allocated by referring the existing instrument master list.

• Proposed instrument number shall be allocated by QC person by entering the details in the instrument master list.

• While procurement of instrument, ensure that adequate space is available for placement, installation and routine operation of instrument.

• The allocation of instrument number in the instrument master list is responsibility of Quality Control Lab Support person.

• Once the instrument is received, the instrument shall be placed at appropriate place and permanent instrument identification number shall be affixed to the instrument.

• Before use of instrument, required installation shall be implanted with the help of instrument manufacturer. Design qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Calibration shall be performed for the instrument before it is to be used for any testing in the quality control laboratory.

5.2 Instrument numbering system:

• Assign the instrument numbering as follows:

• Instrument numbering system for Quality Control Department: QCC-INS-AAA-BBBB

QCC – Stands for Quality Control Chemical Laboratory

INS – Stands for Instrument

AAA – Abbreviation of Instrument Name

BBBB – Unique Sequential Serial Number starting from 0001

Example: HPLC System (QCC-INS-HPL-0001)

• Instrument numbering system for Microbiology Laboratory: QCM-INS-AAA-BBBB

QCM – Stands for Quality Control Microbiology Laboratory

INS – Stands for Instrument

AAA – Abbreviation of Instrument Name

BBBB – Unique Sequential Serial Number starting from 0001

Example: TOC System (QCM-INS-TOC-0001)

• Same instrument identification numbering shall be applied for allocation of all the instruments available in the applicable laboratory.

• The instrument identification number shall be affixed on individual instrument in such a way that while using the instrument, it shall not be removed from instrument, it should not damage the instrument and it should not affect the performance of instrument in any ways.

5.3 Procedure for preparation of master list of instructions:

• Instrument master list if the inventory list of all the instruments available in the chemical and microbiology laboratory.

• The objective of instrument master list is to have details of total number instruments available in the quality control laboratory, instrument make, model, and other relevant information pertaining to the instruments.

• Master list of instrument shall be prepared as per predefined format as per this SOP. Instrument master list shall consist of the information viz. Sr. No., Instrument Id., Instrument name, instrument make, instrument model, date of installation, instrument GAMP Category, Software Version Name, Software Version No., “Firmware Version No., availability of HMI/ IPC/ Desktop PC to operate the instrument, Instrument decommissioning date (if discontinued), and date of decommissioned.

Note 1: HMI – Human Machine Interface, IPC – Industrial Personal Computer

Note 2: Equipment/ Instrument with microprocessor having display shall not be considered under category of HMI. Example – Weighing Balance, pH meter, or Hardness Tester, etc.

• When new instrument is to be installed or old instrument to be decommissioned, details shall be updated in the instrument master list by Quality Control person and it will be verified by QA person with sign and date.

• When details of instrument are updated by handwritten entry in the instrument master list shall be updated in subsequent revision of instrument master list.

• Instrument Master List shall be revised annually or there is no entry left in the list to update with hand written entry.

6. Frequency:

• When new instrument is to be procured and when instrument is decommissioned.

7. Formats:

7.1 Instrument/Equipment Master List

Sr. No.

Instrument/ Equipment Name

Instrument/ Equipment Id. No.

Area/ Location

Make

Model No.

GAMP Category

Software Name

Software Version No.

Firmware Version No.

HMI/ IPC/ Desktop PC

Date of installation

Information regarding de-commissioning

Qualification Status

Remarks

Recorded by (Sign/Date)

Verified by (Sign/Date)

To refer more similar procedures of quality control laboratory, click here.

To refer more SOP of Pharmaceutical Industry, click here