Mini white paper: Evolution in the validation world

Only a few decades ago, in the pharmaceutical industry, it was an acceptable practice to verify packaging machinery only by observing equipment run and checking basic functions. Since the 70’s, the industry has gone through a major change. Many regulations, standards, and guidelines that govern CQV (Commissioning, Qualification and Validation) practices were put in place. With that said, the commensurate level of adaptation was required. Major changes occurred again in 00’s. In the new era, it has to be demonstrated that all risks are mitigated, machines and processes are fit for intended use, and software and all functions operate as designed in a predictable and repeatable manner. To help the industry, Bosch began offering a full array of CQV solutions for new and existing machines or lines. In this article we will discuss how the industry changed, and how Bosch Packaging Technology adapted to the new business environment.

Let’s begin by looking at history… The CQV strategy set forth by the industry in the 90’s was very clear — A “commissioning phase” with FAT and SAT (Factory Acceptance Testing, Site Acceptance Testing) to help protect the commercial interest of our customers; after that, a “qualification phase” with IQs and OQs (Installation Qualification and Operational Qualification) to cover quality aspects; and finally the “validation phase” known as PQ (Performance Qualification) to make sure that a process or machine is operating in a repeatable and predictable manner. The scope of each phase was defined based on the type of process or equipment. In many cases, activities were repeated, for no obvious reason.

In 2006, the US FDA adopted the Quality Risk Management ICH Q9 guideline for the pharmaceutical industry.

“The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient; and the level of effort, formality, and documentation of the quality risk management process should be commensurate with the level of risk.” – FDA Q9, 2006.

The US regulatory body focused on three key areas: product quality, patient safety, and a few years later, on data integrity. In 2007 the ASTM e2500 was released to the industry. It provided a framework for application of the Q9 guideline, and became widely accepted in the industry. The standard emphasizes the value of SMEs (Subject Matter Experts), QbD concept (Quality by Design) and states that a system shall be “fit for intended use.” ASTM e2500 erased borders between commercial and quality activities by introducing the idea of leveraging of already executed activities.

Not only the regulatory world has changed, but also manufacturing processes in the pharma and bio-pharma industries are continuously becoming more complex. Machines come integrated with complicated software packages. Industry demands sophisticated vision, servo, SCADA, and track & trace solutions. Isolators, barrier systems, and complex fill-finish systems are changing the landscape in the industry. There is a lot of buzz about “big data,” “connectivity,” “industry 4.0,” “smart machines,” and some of these concepts are already a new reality. It’s no longer about conveyors and vial handling systems.

Bosch stands out for its highly mature quality management system. We are not only a technology provider, but also offer high quality documentation and service deliverables along with excellent project management processes — now absolute musts in the GMP world. We see a trend that our customers continue to work within the traditional framework of familiar FAT, SAT, IQ, OQ packages, while being flexible in the content. Expertise of Bosch SME’s helps ensure that a new Bosch machine is fit for intended use. A wide range of fully cGMP compliant CQV strategies, products, tools, and services is available to help Bosch customers with commissioning, qualification, and validation needs. We have the technical and software know-how. Our products are tailored to fit customers’ specific quality systems. The right balance between complexity, documentation, and formality is built-in to our CQV processes to mitigate risks and to satisfy regulatory requirements. Bosch experts are trained professionals who deliver the correct level of effort in project planning and execution phases. Bosch is a reliable partner who provides packages for demonstration of compliance. We offer a well-balanced, time- and cost-efficient service. Bosch is your well-equipped CQV supplier who is prepared to help from project concept phase to production, and through life-cycle management of your Bosch equipment.

Author: Andrey Yermakovich, Validation and Quality Supervisor, Bosch Packaging Technology Pharma North America

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