What is Qualification protocol (IQ/OQ/PQ/IFQP), Its Necessity & When requalification performed in CSV?

 

In Earlier post we understood what is Software Code Review & Its Checklist to review source code in Computer system validation?

Now in this article we are going to understand What is Qualification protocol (IQ/OQ/PQ/IFQP), Its Necessity & When requalification performed in CSV? Computer system validation?

Qualification

Qualification is defined as an action of providing that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results

 

It is the process used to establish confidence that the equipment is capable of consistently operating within established limits and tolerances.

 

Need of Qualification

•  To manufactured a quality product

•  Proof “suitability for intended use”

•  Regulatory requirements

•  Cost effective

Qualification Protocols:

Qualification protocols are methods for demonstrating that equipment being used or installed will offer a high degree of quality assurance such that production processes will consistently manufacture products that meet quality requirements.

 

Writing effective IQ/OQ/PQ protocols is a must for following the regulations required by the FDA for equipment, systems, and utilities to demonstrate suitability for the intended use and to operate according to their design and functional specifications

 

In order to prove the requirements are met, Qualification protocols have to be written and followed. These protocols are documented evidence that manufacturing firms are in compliance with cGMPs.

 

Following these guidelines, your facility’s IQ/OQ/PQ protocols will be effective and provide adequate proof of compliance. 

 

Validation is a systematic approach where data is collected and analyzed to confirm that a process will operate within the specified parameters whenever required and that it will produce consistent results within the predetermined specifications.

 

Validation is concerned mainly with processes. When the same approach is applied to a machine or any equipment instead of a process, it is referred to as qualification instead. 

To initiate the qualification of pharmaceutical equipment a frame work before startup is required:

•  Defining User Requirements (URS) Defining Functional Requirements for given User requirements (FRS)

•  Defining Design based on URS & FRS (DQ)

•  Factory Acceptance Test at the site of manufacturer (FAT)

•  Site Acceptance Test at the site of user (SAT)

•  Installation Qualification (IQ)

•  Operational Qualification (OQ)

•  Performance Qualification (PQ)

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User Requirement Specification

User Requirement Specifications consist of Design Specifications and Functional Specifications.  Design Specifications provide explicit information about the design requirements for equipment e.g. the dimensions, material of construction, layout, etc. Functional Specification denotes how each feature of the equipment/system must function.

 

Factory Acceptance Test (FAT)

FAT includes:

•  Checks for completeness of installation.

•  Verification of URS with the actual.

•  Proof of functionality, by either a conventional function test or by simulation.

•  Verification of documents (availability and quality).

•  Overall Review/Inspection.

Site Acceptance Test (SAT)

SAT includes:

•  Verification of equipment design

•  specifications of received equipment at site of User by received documents/drawings from Manufacturer / vendor

•  Physical verification

Design Qualification (DQ)

It includes activities that define the design elements of the instruments such as functional and operational specifications as well as vendor selection criteria.

DQ can be performed by the manufacturers, developers or even the end users.

Installation Qualification Protocol (IQP)

Should confirm that

System has been installed as specified in design document; Specified hardware has been assembled and installed correctly. All the connection such as power supply, network is installed as specified.

For a system is associated with an instrument, whether the instrument has been calibrated (if applicable) and installed correctly

IQ comprises all activities during the installation of the instrument.

IQ checks whether the environment where it is installed is suitable, if the instrument is in accordance with the desired specifications and if the installation procedures have been complied with.

 

Operational Qualification protocol (OQP)

Should confirm that

Testing or Verification of the system against specifications to demonstrate correct operation of functionality that supports the specific business process throughout all specified operating ranges.

It involves collecting document evidence showing that the installed instrument’s performance in the chosen environment will be according to the criteria specified in operational specifications.

Performance Qualification Protocol (PQP)

Should confirm that

System is capable to demonstrate fitness for intended use and to allow acceptance of the system against specified requirements

It requires measuring if the instrument is performing its intended purpose against the activities documented in the PQ stage, which consists of maintenance, change control and calibration.

Infrastructure Qualification:

A separate infrastructure Qualification protocol (IFQP) shall be prepared by IT to perform the qualification of all infra components which are required to implement the software application or based on the design /architecture of application.

Based on complexity& risk of the system, Infra component qualification merged with IQ& OQ protocol of software application.

Hardware Qualification (like Server, workstation etc) shall be performed prior to installation of any Software application on that.

Re-Qualification

Re-Qualification carried out for one or more of the following reasons:

•  To address deficiencies observed in an executed qualification

•  Need for additions in qualification test criteria

•  To qualify changes done in the equipment or a process involving the equipment

•  Failure

•  CAPA

•  Findings/Recommendations from Inspections/Audits/ PQR, etc.

•  Inputs from Preventive Maintenance/Calibration Program

•  Equipment Up-gradation

Qualification Report; 

Project Team executes the pre-approved test script identified in the qualification protocol.

Executed and completed test script submitted to identified reviewer & Approver.

Once all identified Test script post approval completed, Qualification report shall be developed and submitted for review and approval.

The testing is considered as completed successfully once Qualification report approved by Quality team along with closure of all discrepancy (if any).

“Trust but Verify “ Ronald Reagan

 

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