UNIT 5
CALIBRATION AND
VALIDATION
To achieve high quality, pharma manufacturing standards need to
undergo three principles
CALIBRATION
VALIDATION AND
QUALIFICATION
CALIBRATION
It is a technique of correcting or setting a measuring device by
adjusting it to match a dependably known and unvarying measure.
Achieves three main objectives:
1. Checks accuracy of instrument.
2. Traceability of measurement
3. Minimizes uncertainties by assuring accuracy of the test equipment.
PURPOSE OF CALIBRATION
[Link]
[Link]
[Link]
[Link] Control
[Link] Savings (By mapping drift)
[Link] Management
[Link] Improvement (by maintaining cGMP)
Frequency of calibration
• Weekly
• Monthly or bi-monthly
• Quarterly, semi annually or annually
CALIBRATION METHODS
[Link] CALIBRATION
[Link] WITH DATA
[Link] 17025 ACCREDITED CALOIBRATION.
When the measuring instruments be calibrated
When you bring new instrument
Before and after taking critical measurements.
After instances of electrical and or mechanical shock
When accuracy produced is questionable
In case of repairs and requalification of instrument
According to manufacturer’s instruction.
According to the requirement of certain tasks, before the work starts.
QUALIFICATION
Qualification is the approach applied to equipment's,
systems or machines instead of processes. Qualification can
be considered as part of the validation process
Defines the specifications of the
instrument and details the conscious
decision in selection of the supplier
Design qualification (DQ)
Establishes that the instrument is received as
designed and specified, and is properly installed in
selected environment and environment suitability
Installation qualification (IQ) for operation
Confirmatory checks to verify key aspects of
performance of an operation
Operational qualification (OQ)
Verification of instrument performance is
Performance qualification (PQ) according to specifications or not.
VALIDATION
The validation programme assures that a pharmaceutical facility is
meeting the pharmaceutical cGMP guideline as set by regulatory bodies.
METHODS/TYPES OF VALIDATION
Executed before the process is put into commercial
use, a series of 3 consecutive batches are produced,
to carry out runs and observations sufficient to
produce a trend and normal extent of variation
Review of historical manufacturing process.
This validation involves in-process monitoring of
critical processing steps and product testing.
Changes introduced do not adversely affect process
and product quality.
PROSPECTIVE VALIDATION SHOULD INCLUDE:
CALIBRATION VALIDATION
VALIDATION MASTER PLAN (VMP)
• It outlines principles involved in qualification of facility.
• Defines the areas and systems to be validated.
• Provides written programme for achieving and maintaining qualified facility.
• It is a document that details about way accompany will operate, who has
control over various aspects of validation activities, and how production, QC
and personnel management will be directed.
WHO PERFORMS VMP
FUNCTIONS OF VMP
Management education
Project monitoring and management (schedules and time line for
project completion)
Auditing the validation programmes
Planning purpose
Documenting the scope of the validation effort
Products
Process
Procedures
Facility
Equipments
utilities
CRITICAL COMPONENTS OF VMP
Title page and authorization Deviation management in validation
Table of contents Change controls in validation
Abbreviations and glossary Outsourced services
Validation plan Risk management principles in validation
Purpose and approach to validation Training
Scope of validation Validation matrix
Roles and responsibilities References
Analytical method Validation