Calibration of measuring instruments is required to comply with regulations, improve quality assurance, and increase productivity. A Calibration Master Plan (CMP) defines the requirements for an effective calibration program. It outlines which instruments need calibration, calibration frequencies, how calibration will ensure traceability, and how calibration records will be maintained and labeled. The CMP assigns responsibilities to Quality Assurance, Metrology, and instrument-using personnel. It also describes how calibration standards will be adequate and Standard Operating Procedures for calibration will be prepared. The overall goal of the calibration program is to ensure instruments are calibrated within specifications.

1. CALIBRATION OF MASTER PLAN
SMT.KISHORITAI BHOYAR COLLEGE
OF PHARMACY,KAMPTEE
PREPARED BY:DHANSHREE BHATTAD
M.PHARM 1ST YEAR
PHARMACEUTICS DEPARTMENT

2. In pharmaceutical industry, we need to measure many
things such as, length, temp, humidity ,pH, electric
current, pressure, wavelength ,light intensity ,sound
levels, time and so on and for this we need instruments of
reliable quality and this can only be achieve by using
calibrated measuring instruments or device.
A calibration master plan may be defined as “ a leading
document in defining the requirements necessary for
establishing and implementing an effective calibration
control programme’’.

3. Calibration of measuring instrument / device is required for :
1. Complying with government agencies requirements,
2. Improving product quality assurance, and
3. Increasing industrial productivity
 In short a CMP is a document which provides answers for following question namely.
1.What is the purpose of CMP ?
2.Who is responsible for carrying out the activities related to calibration?
3.Which instrument are required to be calibrated?
4.What is the time interval for calibration?
5.To what extent the calibration will provide measurement traceability?
6.How the records of calibration will be maintained?
7.How the calibrated instruments will be labelled?
8.Which calibration SOPs will be used

4. 1.Purpose of calibration:
 The aim of calibration programme is to ensure that all measuring and test
equipment included in the programme are calibrated within the
manufacturers accuracy specification or the tolerance required for the
application.
2.Responsibility for Calibration:
 Mainly personnel from three departments are responsible for the total
control and implementation of calibration activity in any organisation.
They are namely:
Q.A. personnel
Metrology personnel
Instrument using personnel

5. A. QA personnel
They are responsible for establishing a mechanism for assuring the
adequacy of the calibration programme that includes:
 Re-evaluation of all product acceptance decisions utilising
equipment or instrumentation that was subsequently determined to
be out or tolerance.
 Review and approval or decisions to include or exclude measuring
and test equipment (M and TE) into the calibration and/or service
programme.

6. B. Metrology personnel
The responsibility of the metrology personnel are as follows:
 Implementing the calibration programme.
 Developing and maintaining controlled metrology standard
laboratory to support the on going CGMP processes at the facilities.
 To develop and maintain a computerised calibration scheduling system.
C. Instrument using personnel
Users of instruments have following responsibilities:
 To ensure that all the instruments requiring calibration are included in
computerized annual schedule prepared by the metrology department.

7.  Calibrate on daily basis the instruments requiring daily calibration, by users
personnel only, e.g. balances , pH meters etc, metrology department are to be
involved in such calibration work.
 To maintain accurate records of calibration or each piece of equipment
used in cGMP related activities.
3.Time interval for Calibration
The frequency of calibration depends on following factors:
 What is level of accuracy desired ?
 What is the recommendation of manufacturer?
a) calibration intervals must be determined for each piece of equipment and may be
fixed or variable.
b) calibration interval may be based on calendar, cumulative utilization time or any
other suitable criteria.

8. 4.How the measurement is traced?
 Documentation that substantiates and identifies means of achieving direct
traceability should include information such as:
- Calibration contractor, who performed the calibration
- Date of calibration and reference traceability report or certificate.
5.What should be the adequacy of Calibration?
 Items should be calibrated using measurement system having adequate
accuracy, stability and range to completely verify the performance of the
calibrated items within its limits .
 All calibration shall be performed with test standard that have minimum accuracy
four times that of the device under test; wherever possible, and will be traceable to
national standard.

9. 6. How to maintain records of Calibration?
 The individual calibration history files will be prepared and
maintained for each instrument . These records will be maintained
and stored in the metrology or QA department.
7. What should be the labelling practises?
The calibration label should include:
-date of last calibration .
-date of recalibration
-person responsible for calibration
-Calibration certificate number
-Date of calibration

10. 8.How the Calibration SOPs are prepared?
 SOPs should be generally prepared by the metrology department and
approved by QA department. These SOPs should have sufficient info.
for the calibration of measuring equipment.
 These SOPs should have details on following points:
A) Title: manufacturer type or model number of equipment to
which the SOP applies.
B) purpose of the SOP.
C) list of required documentation and materials.
D) description of any safety requirements while doing calibration .
E) Acceptance criteria.
F) comment on recalibration requirement etc.

11. THANK YOU