Pharmaceutical QA: By-Harshita Pant Date-30 April 2020

By-HARSHITA PANT DATE-30th April 2020
Pharmaceutical QA
Q1) What is calibration? It’s method and procedure?
Ans 1)
 Calibration of an instrument is the process of determining its accuracy.

The process involves obtaining a reading from the instrument and
measuring its variation from the reading obtained from a standard
instrument.
OBJECTIVES-
1. Checks the accuracy of an instrument.
2. Determines the traceability of the measurement.
METHODS AND PROCEDURE
1. STANDARD CALIBRATION-
 mostly preferred for calibrating instruments that are non-critical to
quality or are not required for accreditation and license purposes.
2. CALIBRATION WITH DATA-
 Procedure are similar to that of accredited calibration.
 These procedures are not accredited to the ISO standard.
 Not accompanied by data on measurement uncertainties.
3. ISO 17025 ACCREDITED CALIBRATION
 Strictest method of calibration.
 It requires measurement reports which have the details of
measurement that are made against a standard of ‘as found’—
(before calibration is started) and ‘as left’—(when calibration is
completed).
 If the calibration is done by a calibration service provider they must
issue a certificate of the same.
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Q2) Define validation? Explain it with validation master plan.
Ans 2)
 a/c to ISO ---- “ Validation is the confirmation by examination and the

provision of objectives evidence that the particular requirements for a
specific intende use are fulfilled”.
 Validation is an integral part of QA. It involves the systemic study of
systems, facilities and processes aimed at determining whether they
perform their intended function adequately and consistently as specified.
VALIDATION MASTER PLAN(VMP)

 It should provide an overview of the entire validation operation, its
organizational structure, its content and planning.
 The VMP should be a summary document and should therefore be
brief, concise and clear.
 It should not repeat information documented eldewhere but should
refer to existing documents such as policy documents,SOP’s and
validation protocols and reports.
 The format and content should include---
1- Introduction.
2- Organizational structure.
3- Plant/process/product description.
4- Specific process consideration that are critical and those
requiring extra attention.
5- Documentation format .
6- Reference to the required SOP’s.
7- Time plans of each validation project and sub-projects.
8- List of products/process/system to be validated,
summarized in a matrix format validation approach.
9- Re-validation activites, actual status and future planning.
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Q3) How will you calibrate ph meter?
Ans 3)
 By using pH7 and pH2 buffers

Procedure—
a. Select the pH mode and set the temperature control knob to
25°C. Adjust the cal 2 knob to read 100%.
b. Rinse the electrode with deionized water and blot dry using a
piece of tissue.
c. Place the electrode in the solution pH7 buffer, allow the
display to stabilize and , then set the display to read 7 by
adjusting cal1. Remove the electrode from the buffer.
d. Rinse the electrode with deionized water and blot dry using a
piece of tissue.
e. Place the electrode in the solution pH2 buffer, allow the
display to stabilize and , then set the display to read 2 by
adjusting cal2. Remove the electrode from the buffer.
f. Rinse the electrode with deionized water and blot dry using a
piece of tissue.
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Q6) Explain the performance qualification of UV-visible spectrophotometer.
Ans 6)
 Wavelength accuracy---
It is defined as “the deviation of the wavelength reading at an
absorption band and emission band from the wavelength of the band.”
Acceptance:
 ±nm in UV range(200-380 nm) and
 ±nm in visible range(380-800nm
 Stray light-----
Defined as “the detected light of any wavelength that is outside the
bandwidth of the selected wavelength”
Acceptance:
 The transmittance of the solution in a 1cm cell should be less than
0.01 or the absorbance value should be greater than 2
 Resolution power---
The resolution of the UV-VIS spectrometer is related to its spectral
bandwidth. The smaller the bandwidth, the finer the resolution.
Acceptance:
 The ratio of the absorbance at 269nm and asorbance at 266nm
should be greater than 1.5.
 Noise –
it is the measurement affects the accuracy at the both end of the
absorbance scale. Photon noise from the light source affects the accuracy
of the measurement leads to low absorbance
Acceptance:
 The RMS noise should be less than 0.001 AU.
 Baseline flatness----
The flat baseline test demonstrates that the ability of the instrument to
normalize the light intensity measurement and the spectral output at
different wavelength throughout the spectral range.
Acceptance:
 The measurement is typically less than .01AU.
 Stability ----
The lamp intensity is a function of the lamp age, temperature fluctuation
and wavelength of the measurement. These changes can lead to errors in
the value of the measurement over an extended period of time.
Acceptance:
 The deflection is less than 0.002AU/hr
 Linearity---
The linear dynamic range of measurement is limited by stray light t high
absorbance. The accuracy of the qualification of the sample depends on
the precision and linearity of the measurements.
Acceptance:
 Correlation coefficient r ≥ 0.999
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Q5 ) what are the various functions and aims of material management?
Ans 5)
Functions
1- Material planning and programming.

2- Simplification , standardization and value analysis.
3- Inventory control and management.
4- Purchasing of materials in desired quantities without delays.
5- Receiving of incoming materials, storage , preservation &administration
of materials.
6- Transportation & material handling.
7- Disposing of rejects & obsolete materials.’
8- Improving operation efficiency through training.
Aims
1- right quality
2- right time and place
3- right cost
4- right quantity.
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By-HARSHITA PANT DATE-30th April 2020

Q1) What is calibration? It’s method and procedure?

 Calibration of an instrument is the process of determining its accuracy.

METHODS AND PROCEDURE

Q2) Define validation? Explain it with validation master plan.

 a/c to ISO ---- “ Validation is the confirmation by examination and the

VALIDATION MASTER PLAN(VMP)

Q3) How will you calibrate ph meter?

 By using pH7 and pH2 buffers

Q6) Explain the performance qualification of UV-visible spectrophotometer.

Q5 ) what are the various functions and aims of material management?

1- Material planning and programming.

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