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Validation, Calibration and Qualification in Pharmaceutical Industry


Validation provides documented evidence that a process, equipment, method or system produces consistent results (in other words, it ensures that uniforms batches are produced). In pharmaceutical industry process validation is an important and critical part to establish that the process is capable of consistently delivering quality product.

You can also read: Process Validation in Pharmaceutical Industry


Calibration of an instrument is an important part of pharmaceutical industry todetermine its accuracy.The process involves obtaining a reading from the instrument and measuring its variation against a standard.Calibration of an instrument also involves adjusting its precision and accuracy so that its readings come in accordance with the established standard.

Purpose of Calibration

To determine the accuracy, precision, reliability and deviation of the measurements produced by all the instruments.

To make sure that the readings of equipment or instruments are consistent with other measurements and display the correct readings every single time.

Frequency of Instrument Calibration

How often you conduct instrument calibration mainly depends upon its tendency to drift from the true measurement and how it impacts the quality of the end product. Based on this information, you can design a calibration schedule for each instrument. The interval between calibrations can vary as: 

  • Weekly
  • Monthly 
  • Quarterly
  • Half Yearly
  • Annually
  • After every heavy usage of the instrument etc.

Regular calibration of equipment is necessary for proper maintenance of equipment. Because when you regularly calibrate your equipment, you can eliminate the drift at its budding stage instead of allowing it to grow till it affects the measurements in significant ways. In short, regular calibration allows pharmaceutical companies to have confidence in their results which they can record, monitor and control.

You can read also: Difference Between Calibration and Validation


Qualification is the action of proving and documenting that any equipment or ancillary systems are properly installed, work correctly, actually show the expected results. It refers to activities undertaken to demonstrate that utilities and equipment are suitable for their intended use and perform properly.

Flow of Qualification

Qualifications are as follows: Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification.

URS/DS > FAT > SAT > DQ > IQ > OQ > PQ

Steps of Equipment Qualification

There are four stages of Equipment Qualification

  • Design Qualification (DQ) 
  • Installation Qualification (IQ) 
  • Operational Qualification (OQ) 
  • Performance Qualification (PQ)

Design Qualification (DQ) 

It is a documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended use.DQ should be performed when new equipment is being purchased, or when existing equipment is being used for a new application. DQ serves as the precursor to defining the equipment Installation Qualification (IQ) and OQ protocols. The purpose is to ensure that all the requirements for the final systems have been clearly defined at the initial.

DQ check items: 

  • GMPs and regulatory requirements 
  • Performance criteria 
  • Reliability and efficiency 
  • Commissioning requirements 
  • Construct ability and installation of equipment 
  • Safety and environment impact 
  • Description of the intended use of the equipment 
  • Preliminary selection of the supplier 
  • Final selection of the equipment

Installation Qualification (IQ)

It is documented evidence that the premises, supporting utilities, the equipment have been built and installed in compliance with design specifications.It verifies that the equipment has been installed in accordance with manufacturer recommendation in a proper manner and placed in an environment suitable for its intended uses.

IQ check items:

  • Equipment design features
  • Installation conditions
  • Calibration, preventative maintenance, cleaning schedules
  • Safety features
  • Supplier documentation, prints, drawings and manuals
  • Software
  • Spare parts list
  • Environmental conditions
  • Any problems identified during IQ

Operational Qualification (OQ)

It refers to establishing by objective evidence process control limits and action levels which result in product that all predetermined requirements. OQ is the process of demonstrating that an instrument will function according to its operational specification in the selected environment.

OQ check items:

  • Process control limits (speed, time, temp., pressure etc.)
  • Software parameters
  • Process operating procedures
  • Potential failure modes, action levels and worst-case conditions

Performance qualification (PQ)

It refers to establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements.PQ should always be performed under conditions that are similar to routine sample analysis.

PQ check items:

  • Actual product and process parameters and procedures established in OQ.
  • Assurance of process capability as established in OQ.
  • Process repeatability, long term process stability.

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