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Standard Operating Procedure For Log Book System

by Pharmadocx Consultants

PURPOSE:   

To define a procedure for maintaining Logbooks for equipments, lab instruments, chemist & analysts and machine calibrations.

SCOPE:        

This procedure applies to all logbooks maintained in the company.

No matter how trivial some may appear.

RESPONSIBILITY  :

Dept. Executive/ Chemist,   Dept. Head

PROCEDURE:

Log-book is maintained depending upon the user department, the Log book should contain the following details:

a). Equipments:

  1. Name of Equipment
  2. Code No.
  3. Product & its batch numberRemarks if any
  4. Signature of chemist and signature of the person checking

b). Lab Instruments:

a)   Instrument Name

  • Sr. No
  • Date of analysis
  • Analysis time
  • Product analysed & its batch number
  • A.R. No.

Remark of analysis if any  Signature of analyst and signature of the person checking the analysis report

c). Chemist / Analyst’s Log Books:

a. Date of analysis

b. Product analysed & its batch number

c. Name of the test, analysis data and calculation details.

d. Signature of analyst and signature of the person checking the analysis repo

d). Calibration of  Log Books:

a. Instrument Nam

b. Range

c. Accuracy

d. The standard used

e. Calibration frequency

 f.  Model no.

g. Signature of person calibration the equipment / instrument and signature of the     person reviewing the calibration report.

Note: If any instrument is malfunctioning or requires non-routine maintenance, work order should be generated by the Analyst / chemist responsible for calibration of that instrument and maintenance details to be entered in instrument log book / chemist log book.

  1. Equipment / Instrument Name
  2. Service required data
  3. Date repaired
  4. Nature of repair work carried out in detail
  5. Re-calibration date
  6. Signature of chemist and date
Author: (GM Production)Checked by: (QA Manager)Authorised by: (Director Technical)
Date:Date :Date :

             (Review date on or before 12 months from date of authorization)

Written by Anmol Singh

Anmol Singh Completed his Bachelors in Field of Mechanical and Automation Engineering. He has over 2 Years of experience in field of Pharmaceuticals, Medical Devices, Cosmetics Manufacturing.

12 June 2023

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