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 Standard Operating Procedure (SOP) and Format for Instrument, Equipment usage logbook used for day to day activity and recording of usage details in pharmaceuticals.

Equipment Usage Logbook

1.0   PURPOSE:

• • This purpose of this SOP is to define the procedure for issuance, handling, making entries and review of   “Instrument/ Equipment usage logbook”.

2.0   SCOPE:

• • This procedure is applicable to Instrument/Equipment usage logbook used in Quality Control department.

3.0   REFERENCES:

• • In- house
  • SOP : Maintenance of laboratory instruments.

4.0   RESPONSIBILITY – EQUIPMENT USAGE LOGBOOK:

• • QC Analyst shall be responsible for making online Equipment usage logbook entries as per the SOP.

• • Reviewer or designee shall be responsible to review and verify the entries in the Equipment usage logbook.

• • QC Head shall be responsible to check the SOP and to ensure that the practice is followed as per the SOP.

• • QA shall be responsible to ensure the implementation of the system as per the SOP.

5.0   ABBREVIATIONS:

• • GC : Gas Chromatography (SOP for GC Calibration)

• • GLP : Good Laboratory Practices (SOP for GLP)

• • HPLC : High Performance Liquid Chromatography (SOP for Waters HPLC System)

• • KF : Karl Fischer

• • UHPLC : Ultra  High Performance Liquid Chromatography

• • UPLC   : Ultra Performance Liquid Chromatography (SOP for UPLC Calibration)

 6.0   PROCEDURE – EQUAIPMENT USAGE LOGBOOK:

• • Issuance Procedure of Instrument/equipment usage logbook :

• • Head QC or designee shall issue the logbook (register) to analyst.

• • Make the entries in “log book issuance register” for “Sr No.”, “Hard book/Notebook No.”, “Name of Hard book/Note book ” (where log book is issued for the reporting of the analysis performed, then mention name of analyst and for others purpose mention name of log book) ”, “Issued to”, “Date of Issue”, “Issued by” as per Attachment – 1.

• • Analyst shall label or manually write the details on the log book for “Name of Hard book / Note book” and “ log book No.”.

• • Issue the log book separately for the specific requirement.

• • After completion of the log book analyst shall submit the log book to Head QC or designee and Head QC or designee shall make a entry in the “ log book issuance register” for the “Date of completion”, “Received by” , “Archived by/date” and “Remarks”.

• • log book shall be issued for current calendar year but in case analysis is in continuation/non availability of log book same log book shall use for the raw data writing for the next year.

• • On line entry practices in the log book :

• • Before starting the analysis, analyst shall enter the product details like Product name, B.No, A.R.No., test in respective instrument log book.

• • After receiving of samples in QC concerned person shall enter all the details in respective log book.

• • Log book Maintenance :

• • Keep all blank (unused) and filled log books into lock and key.

• • Maintain the track record of issued and closing of log book in Quality Control.
  • Analyst shall make entry in “Instrument/equipment usage log book” at the time of analysis on that particular instrument/equipment or during its calibration.

Note: For instruments with Waters Empower, log book entry for instrument/column usage shall be done online in electronic log book using the software.

• • In case the instrument/ equipment is not to be used (due to maintenance or any other reason) , put respective label on the instrument as per  SOP “Maintenance of Laboratory instruments” and

• • Make an entry  for the same in the respective Equipment usage log book along with sign and date. 

• • If instrument/equipment operation is discontinued/halted in between the analysis then analyst shall write the reason for discontinuation in the remarks column with sign and date.

• • No column should be left blank without entry in any Equipment usage log book. Put “N/A” (Not Applicable) in columns where the entry is not required/ not relevant.

• • Reviewer/checker shall check the entries done in the Equipment usage log book.

• • Put checked by sign with date at the bottom of each page in ball point pen only.

• • For Equipment usage log book in which analysts cross verify each others entries (e.g Balance, pH meter, Conductivity meter etc.), “Checked by” sign and date shall be put in ball point pen by the analyst.

• Handling of Erroneous entries in the Equipment usage logbook :

• • For the entries made in wrong  Equipment usage logbook :

• • Justification  shall be written in the “Remarks” column of the log book  where  entry was been mistakenly done.

• • Reference log book  shall be written in which the correct entry has been made.

• • Justification shall be signed by the analyst as well as a verification sign shall be taken by the section head or designee

• • If any Equipment usage logbook Missing Entry:

• • Make the entry in the log book

• • Write the justification for missing the entry along with the analyst sign and date.

• • A verification sign shall be taken by the section head or designee against the justification.

• • If any entry is cancelled:

• • Write the justification written for cancelling the entry.

• • The analyst shall put sign and date against the justification and shall take a verification sign by the section head or designee.

Note : In case the section head or designee  is unavailable, verification sign taken by any other analyst  or supervisor  present in the shift.

• • After the completion of analysis, analyst shall clean the instrument/equipment as per its respective cleaning procedure

• • Make the entry in cleaning status column of instrument/equipment usage log book of respective instrument/equipment.

• • At the end of each month, the entries in the Equipment usage log book shall be closed and entries for new month shall be started from new page.

• • After the completion of Equipment usage logbook, the analyst shall submit the log book to GLP section.

• • The concerned person from GLP shall issue new Equipment usage logbook for the  instrument/ equipment  whose log book  is filled and shall  archive the filled log book as per the procedure .

7.0   ANNEXURES – EQUAIPMENT USAGE LOGBOOK :

Attachment – 1 : Issuance of Log book

Annexure 2 : Instrument/Equipment Usage Logbook

Name of Instrument/Equipment:                                            Code No.:                                                       

Annexure 3 : HPLC/UPLC/UHPLC+/GC Usage Logbook

Annexure 4 : KF Apparatus handling of logbook

Annexure 5 : Raman Analyzer Library Creation Log Book