IQ OQ PQ in the Pharmaceuticals

Learn about Installation Qualification, Operational Qualification and Performance Qualification (IQ OQ PQ) in the Pharmaceutical industry.

Introduction (IQ OQ PQ)

In the pharmaceutical sector IQ OQ  PQ are utilized throughout validation procedures.Installation qualification, operational qualification, and performance qualification are denoted by the acronyms IQ OQ PQ, respectively. These are the three steps of a validation process that are widely utilized in many different industries, but are especially prevalent in the medical device and pharmaceutical industries. These certifications are necessary to guarantee that systems and equipment fulfill requirements and are appropriate for the purposes for which they are intended. An outline of every qualification stage is provided below:

Installation Qualification (IQ)

Installation Qualification  is to confirm that the system or equipment has been installed appropriately in accordance with the design and specifications provided by the manufacturer.The functions of IQ include making sure all necessary documentation is in place, checking and documenting the installation of equipment, confirming proper settings, and validating utility connections.

Read Also:  What is Pharmacovigilance?

Operational Qualification (OQ)

The goal of Operational Qualification is to make sure that the system or equipment performs as planned and satisfies established operational specifications. Activities include evaluating performance, recording outcomes, and testing the equipment’s operation in a range of working environments. At this point, it’s common to conduct particular measurements and tests to show that the equipment operates within reasonable bounds.

Performance Qualification (PQ)

The Performance Qualification is to show that the apparatus or system satisfies user needs and operates reliably in its designated operating environment. Testing to make that the system or equipment fulfills performance standards for an extended length of time under typical operating conditions. This stage, which frequently incorporates real-world situations, is intended to verify that the apparatus or system satisfies user requirements and legal requirements.

Read Also: 100 Questions and Answers About Pharmaceutical

Conclusion 

The equipment or systems used in regulated sectors must be dependable, efficient, and compliant with all applicable rules and laws. These IQ OQ PQ qualification steps are a component of a larger quality assurance and validation process. A high standard of quality in industrial processes and regulatory compliance depend heavily on the documentation produced during IQ, OQ, and PQ.