PROCEDURE FOR IN-HOUSE & OUTSIDE PARTY CALIBRATION

PROCEDURE FOR IN-HOUSE & OUTSIDE PARTY CALIBRATION

PURPOSE: To lay down a procedure for calibration of all the testing and measuring instruments or devices used to measure critical processes that can have an impact on the quality of the product.

SCOPE: This procedure covers the calibration of measuring instruments like pressure gauges’ temperature gauges, vacuum gauges, temperature indicators, sensors, temperature recorders manometers, etc.

OTHER RESOURCES: BURN CURE CREAM (Acriflavine & Thymol Cream)

ATTACHMENTS:

DEFINITIONS:

Calibration: Calibration defines measurement parameters such as range, accuracy, and precision of an instrument. It is one of the major parts of pharmaceutical manufacturing standards and quality assurance.

RESPONSIBILITY:

1. QA Department Person:

• To prepare calibration schedules for measuring instruments or devices.
• To ensure timely calibration of the equipment and measuring devices.
• To review the calibration certificate of the devices.
• To deal with an external agency for calibration.
• Coordinate with the engineering department to replace the faulty equipment and instruments.

2. Engineering department:

• To replace faulty equipment and
• To provide utility for calibration to calibration party person.
• To ensure recalibration is performed timely.
• To be involved in calibration with an outside calibration party person at the time of calibration.

3. Quality assurance (QA) Head:

• To ensure implementation of the defined system.

4. Plant Head:

• To ensure implementation of the defined system.

PROCEDURE:

PROCEDURE FOR CALIBRATION

• A separate calibration plan for in-house calibration and outside-party calibration shall be prepared at the beginning of each year for all instrument/equipment to be calibrated on
  dates as per their frequencies.
• Calibration of Equipment / Instrument shall be carried out at suitable intervals based on the manufacturer’s recommendation, historical experience, and criticality of use.
• Calibration standards for in-house or contract service must be traceable to a recognized National Standard and within the calibration validity period.
• All traceability certificates shall be checked and reviewed by Officer-QA.
• In house Calibration:
• An in-house calibration plan shall be prepared by the QA Officer as per Attachment-II.
• The in house calibration plan shall have the following information.
  • Department,
  • Frequency,
  • Year,
  • Names of Instrument / Equipment/Sub-Component.
  • Identification No. (ID No.).
  • Make
  • Location
  • Status (Target date, Actual Date),
  • Month (January to December)

OTHER RESOURCES: PIPERAZINE SYRUP

Outside Party Calibration:

• In case of outside party calibration, a technical contract shall be signed with the party specifying the general conditions of calibration using agreed methods.
• Calibration shall be carried out at the site in the presence of a supervisor/officer of the concerned department.
• The acceptance criteria for calibration of instrument/equipment shall be provided by the company to the external calibration based on the equipment requirements.
• Calibration of instruments shall be done as far as possible in the location of its use.
• If calibration is not possible at the site, shall be sent to the site of an outside agency.
• The HOD of the concerned department shall ensure that calibration is being carried out as per the respective SOP.
• If any equipment/instrument is found out of calibration, label it as “UNDER MAINTENANCE” and inform to Head – of Engineering and Quality Assurance for appropriate action.
• In case the instrument is out of calibration it gets promptly reported and steps are taken to remove it from service.
• Instrument/equipment shall not be further used till complies with the calibration requirements. After successful calibration, the instrument shall be labeled with a Calibration sticker indicating the Instrument Name, date of calibration, Instrument ID No., the signature of the person who carried out the calibration, and the next due date of calibration, etc.
• Cleaning, Maintenance, or moving of an instrument can alter the calibration status and accuracy of data. Hence any such activity with the instrument should be asses and recalibrated (whenever required) and documented in the calibration record.
• Re-calibration shall be done in case of any maintenance or re-installation of instrument/equipment whenever applicable and the record shall be maintained.
• Instrument/equipment shall not be further used till complies with the calibration requirements or is verified for correct working.
• The frequency of outer calibration shall be yearly.
• The calibrating agency shall issue a certificate of calibration concerning each instrument/equipment calibrated.
• The calibration certificate shall have details like identification of the instrument, the range of calibration, standard calibrators used and their traceability, the date of calibration, the actual values obtained, the date on which the next calibration is due, and the signatures of the person who carried out the calibration activity.
• Each certificate of calibration of instrument/equipment shall be reviewed and endorsed by Q.A. personnel and a photocopy of the same shall be issued to the owner department if required.
• Along with these calibration certificates, the calibrating agency shall also provide copies of the calibration certificates of the standard calibrators used, traceable to National Standards.
• Ensure that the resolution (least count) of the calibrator should be less than the resolution of the equipment/ instrument to be calibrated.
• In case if new instrument is installed same shall be added in the addendum for the calibration planner as per Attachment-IV addendum shall be incorporated in next year’s calibration planner.
• An outside calibration plan shall be prepared by the QA Officer as per Attachment II.
• The Outside calibration plan shall have the following information.

• • • Department,
    • Year,
    • Names of instrument / Equipment/Sub-Component,
    • Identification No. (ID No.),
    • Range,
    • Least Count,
    • Make/Model,
    • Location,
    • Frequency of calibration,
    • Due date of calibration,
    • Done Date of calibration,
• Follow–up for out-of-calibration:
• The details of’ Out of Calibration’ shall be recorded in the logbook of respective instrument/equipment and informed to the engineering &QA department.
• Owner department Fill the work order and send it to the engineering department.
• HOD-Engineering shall take the corrective action accordingly.
• The QA officer shall access the number of batches affected or the number of analyses affected and the impact of the same on the quality.
• Calibrate the instrument/equipment after rectification as per the respective calibration SOP.
• Record the calibration in the log of the instrument/equipment.

Verification planner:

• A verification plan shall be prepared at the beginning of each year for all instruments / Equipment to be Verified as per their individual frequencies as per Attachment-III

Calibration frequency

• Outside Calibration: Yearly: ± 1 Month
• In-House : Monthly: ± 3 Days
• Daily: None
• Verification:     Yearly ± 30Days

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