IQ, OQ, PQ
Installation Operational Performance
What are IQ, OQ and PQs?
After the installation of a new water system there are qualification periods to ensure that the system is operating as defined by the user requirement specification (URS). There is also a requirement to ensure that the system is producing water compliant with the specifications outlined in the pharmacopoeial monograph. Installation Qualification (IQ) is defined by regulatory bodies as establishing confidence that a water system meets the original design specifications set out by the manufacturer. The next phase is Operational Qualification (OQ), this phase allows us to determine if the system is capable of continuously providing water of the quality defined in the User Requirement Specification (URS) in accordance with the relevant regulatory requirements. The final stage is Performance Qualification (PQ), this is not dissimilar from the OQ stage, but is conducted over a longer period of time. A PQ assesses the capabilities of the system to produce compliant water reliably over the course of a year of normal operation.
Why do we carry out these tests?
All stages of validation are essential in order to ensure that the system can consistently yield water of the required quality. Achieving this quality is essential for meeting the regulatory requirements defined in the pharmacopoeial monographs. In addition, getting this stage wrong can have disastrous consequences for a pharmaceutical manufacturer. A lack of consistency and system confidence can in the worst case lead to product recall costing millions as a result.
How can we help assure compliance?
We are water systems experts, Honeyman provides a full turn-key solution right from system design and installation to the final PQ. Our laboratories are able to provide a flexible, on-demand service to deal with high volumes of IQ, OQ and PQ samples in a short window. Think of us as an extension of your own laboratory. We are able to provide the full suite of cGMP microbiological and chemical testing to ensure compliance with all major pharmacopoeias and client defined specifications. A list of typical qualification services we provide for our clients are as follows:
Our microbiological analysis includes:
- Total viable count (TVC) via membrane filtration
- Limulus Amebocyte Lysate (LAL) turbidometric kinetic assay for the detection of endotoxins, also known as an Endotoxin test
Our suite of chemical tests to ensure compliance include:
- Total Organic Carbon (TOC)
- Heavy metals
For high intensity PQ phases over 28 days we have a dedicated courier and laboratory team that work weekdays and weekends. We ensure that all results are delivered reliably, accurately and promptly. Any out-of-specifications are investigated fully upon client request to ensure the swift resolution of any issues that may arise.