The commissioning process has been implemented on numerous construction project types as the primary method of ensuring project quality. When required, the process can be enhanced in certain areas to account for increased risk associated with critical systems and facilities (e.g. data centres, laboratories, launch complexes, etc.). Yet, even with the commissioning processes’ ability to adapt, some industries still feel the program falls short.

In the pharmaceutical industry, there are two major levels of ensuring quality when referring to the infrastructure systems. They are Commissioning and Qualification. Within this industry, systems are categorized as one of three types in relationship to the production of a pharmaceutical:

Direct Impact – system has a direct impact on the product quality.
Indirect Impact – system is not expected to directly impact the product quality, but typically supports a “Direct Impact” system.
No Impact – system will not have any impact on product quality.

Commissioning is applied to all major systems. For the “No Impact” and “Indirect Impact” systems, commissioning is often the sole mechanism of ensuring quality of construction. However, for “Direct Impact” systems, an enhanced form of “Qualification” is required to satisfy the governing bodies, such as the United States Food and Drug Administration (FDA) that regulate the industry. These Qualification Practices include Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).

This generates are a number of questions. Such as:

1. What are the differences between Commissioning and FDA Qualification?

2. Are other industries not requiring IQ, OQ & PQ suffering due to substandard verification?

3. Can commissioning adopt IQ, OQ & PQ principles to streamline pharmaceutical verification?

Your Email:
Your Question:	Send Question

Commissioning—A One-Stop Shop for the Pharmaceutical Industry .wc-legacyPageTitle, .GeneralHeader, .HeaderStyle1, #wc-eventDetailsPageTitle, #wc-eventRegistrationPageTitle { display: none!important; }

Sponsors

Related Links

Attendees

Questions

Commissioning—A One-Stop Shop for the Pharmaceutical Industry