SOP on maintaining Quality Control equipment / instrument log book

SOP on maintaining Quality Control equipment / instrument log book

Objective :

  • To lay down the  procedure for maintaining equipment / instrument log book in Quality Control Department.

Scope:

  • This procedure is applicable for maintaning equipment / instrument log book in Quality Control Department .

Responsibility:

Chemist or above of QC department

Accountability:

Head Quality Control

Procedure:

log book

  • The equipment / instrument log book shall be maintained for all equipments / instruments used in Quality Control department.
  • The master format of equipment/ instrument log book shall be controlled by Quality Assurance department.
  • The QA department shall issue the control copy of instrument log book.
  •  In instrument log book, analyst shall enter the start time just after analyst starts work on respective instrument.
  • The end time shall be entered immediately at the end of operation.
  • If instrument is not working properly then record observation in Instrument Breakdown History Record as per Annexure No. A03 and affix “OUT OF ORDER” label as per Annexure No. A03 and follow  for further action.
  • HPLC/GC instrument log book  shall be as per Annexure No. A01  and instrument log book of rest of the instruments shall be as per Annexure No. A02 .

Note :  All entries shall be done online. Not more than one entries are allowed in one row.

List of Annexure / Formats:

S.

No.

Format TitleAnnexure

Number

1Instrument Log Book (HPLC / GC)A01
2.Instrument log book (General)A02
3.Instrument Breakdown History RecordA03

References (if any):

Reason for Revision:

Not applicable due to first version.

Abbreviation:

  • QC                        : Quality Control
  •  QA                         : Quality Assurance
  • SG                         : Sub-General
  • SP                         : Specific

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Quality Control Department

Instrument Log Book (HPLC /GC)

Name of Instrument :                                                                     Instrument ID. No.:

Sr. No.DateSample NameBatch No.Test PerformedColumn ID. No.Start TimeEnd TimeNo. of InjectionsUsed ByChecked ByRemarks
            

Quality Control Department

Instrument Log Book (General)

Name of Instrument :                                                                         Instrument ID. No.:

Sr. No.DateSample NameBatch  No.Test PerformedStart TimeEnd TimeUsed ByChecked ByRemarks
          

 

Quality Control Department

Instrument Breakdown History Record

Name of Instrument :                                                                           Instrument ID. No.:

 

Sr. No.DateProblem OccurredVerified ByAction TakenProblem Rectified onRectified ByVerified ByRemarks
         

 

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About Alice

Alice is the Author and founder of Drugsformulations, she is a pharmaceutical professional having more than 18 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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