calibration master plan

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CALIBRATION MASTER PLAN:

CALIBRATION MASTER PLAN PRESENTED BY: Jyoti K Bachhav M. Pharm .(QAT.) First Semester, R. G. Sapkal college of pharmacy, Anjaneri , Nashik .

contents:

contents Introduction of calibration. Definition. Purpose of calibration. Equipment classes. Calibration master plan. Calibration process. Labeling practices. Calibration certificate

CALIBRATION :

CALIBRATION To maintain the accuracy and precision of test equipment at all times. To ensure highest level of confidence in all measurement that affect materials disposition decision, with unbroken chain of traceability to national standard. To determine whether the equipment is still fit for its intended purpose.

PowerPoint Presentation:

Conti… It is based on the comparison of a primary standard or instrument of known accuracy with another equipment (to be calibrated). It is used to detect, correlate, report or eliminate by adjustment of any variation in the accuracy of the equipment being calibrated.

Defination:

Defination Calibration defined as “comparison of measurement system or device of unknown accuracy to another measurement system or device of known accuracy to detect, correlate report or eliminate by adjustment any variation from required performance limits of unverified measurement system or device ”

Purpose of calibration:

Purpose of calibration

Why Calibrate?:

Why Calibrate? Properly calibrated equipment provides confidence that your products/services/results meet their specifications . Calibration: Optimizes resources; Ensures consistency; and Ensures measurements (and perhaps products) are compatible with those made elsewhere. By making sure that your measurements are based on international standards, you promote acceptance of your products/services/results .

PowerPoint Presentation:

Critical equipment: Direct measurement that affect the final product quality. Measurement on critical process parameters in the process specification. Non critical equipment: Indirect measurement that will not directly affect the final product quality. Shall be maintained based on company maintenance schedule. Equipment classes

CALIBRATION INTERVAL:

CALIBRATION INTERVAL

PowerPoint Presentation:

Calibration Master Plan Include the control of all critical measurement equipment that contain the following details. Name Identification by model # and serial # Location Owner/responsible Calibration frequency Calibration due date 13

REFERENCE STANDARD&MATERIAL :

REFERENCE STANDARD&MATERIAL Reference standard it shall be calibrated by a body that can provide traceability. Such reference standard of measurement held by the laboratory shall be used for calibration only. It shall be calibrated before and after any adjustment. Reference materials where possible, it shall be traceable to si units of measurement, or to certified reference materials. Internal reference material shall be checked as far as is technically and economically practical.

PRIMARY STANDARD :

PRIMARY STANDARD Highest accuracy order in the measurement system Traceable to national or international standard

CALIBRATION IDENTIFICATION:

CALIBRATION IDENTIFICATION Status of equipment calibration shall be available and affixed to the equipment where applicable. Equipment identification shall bear the following information: Name of equipment Serial no. Date calibrated Status Schedule of next calibration and Initial/signature of the person who performed the calibration

CALIBRATION PROCESS :

CALIBRATION PROCESS Calibration process must be managed and executed in a professional manner: A particular place for all calibration operations to take place and keeping all instruments for calibration A separate room is preferred: (1) better environmental control. (2) better protection against unauthorized handling or use of the calibration instruments.

PowerPoint Presentation:

Conti… The performance of all calibration Operations is assigned as the clear responsibility of just one person. Calibration procedures, used for quality control functions, are controlled by the international standard ISO 9000. It requires that all persons using calibration equipment be adequately trained .

HOW THE MEASUREMENT IS TRACED?:

HOW THE MEASUREMENT IS TRACED? The calibration system should provide the tracing of the measuring instrument to national standards . Documentation that substituentiates and identifies means of achieving direct traceability should include information such as: Calibration contractor, who performed the calibration. Certification data-the certified values determined by the measurement process, where applicable required. Date of calibration & reference traceability report or certificate.

HOW TO MAINTAIN RECORDS OF CALIBRATION .:

HOW TO MAINTAIN RECORDS OF CALIBRATION . Records will be maintained for all M & T.E. That are included in the calibration control program.The individual calibration history files will be prepared and maintained for each instrument . These records will be maintained and stored in the metrology or Q.A dept .

WHAT SHOULD BE THE LABELING PRACTICE?:

WHAT SHOULD BE THE LABELING PRACTICE? All calibrated equipments are labeled or coded to indicate its status. Labels should be design &made of material suitable to the working environment e.g Labels.

following declaration be made. :

following declaration be made . “ Calibrated” “Calibration not required ” Label should contain, Date of last calibration Date of recalibration Person responsible for calibration. Calibration certificate number Date of calibration.

OUT OF CALIBRATION:

OUT OF CALIBRATION Remove equipment from use. Out of calibration investigation to be carried out to determine the source of inaccuracy. Evaluate the impact of ooc result on the final product quality and other previously measured data. All investigation findings should be documented .

CALIBRATION CERTIFICATE:

CALIBRATION CERTIFICATE Name and address of contracted calibration laboratory Name and address of client Description and identification of item calibrated Environment conditions when calibration was made Date of receipt of instrument, date of calibration and date of next calibration Calibration method Result of calibration Signature and title of person responsible for the calibration External calibration contract shall be awarded to accredited by the nation institution

REFERENCES:

REFERENCES Guideline on ASEAN cosmetic GMP (2003) U.S. Food drug administration, center for food safety applied nutrition, cosmetic compliance program. Who guideline for sampling of pharmaceuticals and related materials. 25

THANK YOU…….:

T H A N K Y O U ……. 26

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