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SOP on Calibration of Production Instruments

  • Objective :To lay down a general procedure for calibration of production instruments.
  • Scope:This Standard Operating Procedure is applicable for formulation plant of Pharmaceutical company name with location.
  • Responsibility
    • Production Supervisor / Officer shall be responsible for calibration of production instruments as per this SOP (For Instruments which shall be calibrated In-House).
    • Head-Production / designee shall ensure implementation of this SOP.
    • Head-Engineering / designee shall coordinate with outside agencies or suppliers for calibration of instruments.
    • Head production shall be responsible for compliance of this SOP.
  • Abbreviations and Definitions

SOP- Standard Operating Procedure

ID No. – Identification Number

QA – Quality Assurance

  • Procedure
    • Instruments associated with processing, monitoring and inprocess testing of products and areas shall be calibrated either by In-house procedure or by external authorized agencies as per Calibration Schedule (Annexure-1)
    • Instruments identified for calibration from external authorised agency shall be procedurised as per the SOP.
    • The instruments identified for In-house calibration shall be calibrated as per the specified frequency and the frequency is derived on the basis of criticality and usage.
    • The instruments to be calibrated In-house shall be calibrated as per following:
    • Calibration of in-house instrument shall be done as per respective SOP. Each Standard Operating Procedure for calibration of instrument shall discuss following minimum requirements.
    • Frequency of calibration of any instrument shall be designed based on criticality of its parameters or on manufacturer recommendations.
    • Acceptance Criteria of the calibrated instruments shall be in compliance with specifications of the respective instruments.
    • A specimen format shall be attachment as per respective instrument’s calibration SOP, for recording the observations.
    • Use of calibration standards traceable to National or International standards. These calibration standards shall be calibrated from out side agency in co-ordination with engineering department as per the SOP.
    • A label shall be attached to each instrument after calibration with status as ‘CALIBRATED’ status as per SOP.
    • If the instrument is out of calibration limit it shall be labelled as ‘Calibration Failed’ as per SOP and the corrective action shall be taken and the instruments shall not be used for production till the problem is rectified and instruments is re-calibrated. In case of internal calibration failure work order shall be raised by production to engineering department
    • Calibration record shall be kept for three years from the date of calibration.
    • Forms and Records
      • Calibration Schedule –  Annexure-1
    • Distribution
      • Master Copy – Documentation Cell (QA)
      • Controlled Copies – Production, Quality Assurance and Engineering
    • History
Date Revision Number

Reason for revision

         – 00 New SOP

 

                                                                           Annexure-I                                                                

                                                               Calibration Schedule

                                     (For Instruments From External Authorized Agencies) 

S. No. Name of Instruments Frequency of Calibration
1 Ampere Meter Annual
2 Conter/Rate Indicator Annual
3 Counter Meter Annual
4 Differential  Pressure Transmitter Annual
5 Digital Ampere Meter Annual
6 Digital Proportional Integrated Derivative  controller Annual
7 Flow Meter Annual
8 Hour Meter Annual
9 Hygrometers Annual
10 Linear Scale Annual
11 Load Cell Annual
12 Magnehelic Gauge Annual
13 Manometer Annual
14 Pressure Gauge Annual
15 Pressure Switch Annual
16 Pressure Transmitter Annual
17 Relative Humidity/ Temperature Controller Annual
18 Rotation Per Minute Meter Annual
19 Temperature Transmitter(RTD) Annual
20 Temperature Gauge Annual
21 Vacuum Gauge Annual
22 Conductivity Meter Annual
23 Oxidation Reduction Potential Meter Annual
24 Volt meter Annual
25 Scale Annual
26 Timer Annual
27 Weight box( Up to 200 gm) Annual
28 Digital hygro/Temperature meter Annual
29 Vacuum Transmitter Annual
30 Thickness Gauge Annual
31 Multi meter Annual
32 Level transmitter Annual
33 Tachometer Annual
34 Stop watch Annual
35 Vernier caliper Annual
36 Glass Thermometer Annual
37 Dial Gauge Annual
38 Thermostat Annual
39 PH Meter Annual
                                                               Calibration Schedule

                                                 (For Instruments Calibrated In-House) 

S. No. Name of Instruments Frequency of Calibration
1 Analytical Weighing Balances Daily
2 Weighing Balances Once a Month
3 Disintegration Test Apparatus Once a Month
4 Hardness Tester Once a Month
5 Friability Test Apparatus Once a Month
6 Halogen Moisture Analyzer Six Months
7 PH Meter Weekly

 

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit 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. He 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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