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PIA-PR presents top priorities during 16th FDA Regulatory Conference
Published Tuesday, June 26, 2018 11:00 am
by Contributor
on reporting), and then to the framework (what you really need).

“If you have a 100-page report it could be difficult to focus on the areas that are relevant. Refocus on higher risk items! If you are asking yourself whether to integrate and upgrade a system, rely on these steps: Identify the business process, determine the GMP relevance and outline the business benefits and efforts,” he advised.

Anthony Mire-Sluis, head of Global Quality at AstraZeneca Pharmaceuticals, drove his quality presentation towards the importance of simplification, people in the organization and the need for an-ever-present quality mind and mission.

“Protect the simplification mindset. It makes a big difference. Simplify SOPs. Focus on RELEVANT metrics. Understand your business. Share knowledge across networks. Simplify with a focus on operators and end users,” he said.

“At the end of the day, quality systems and quality controls are tight up to people. Use tablets for SOPs. You need knowledge sharing databases to transform internal and external cGMP information,” Mire-Sluis added.

Plants are smaller, built quicker
Ganesh Vedantham, executive director of Process Development at Amgen presented the importance of single use systems (SUS) in manufacturing for speed and flexibility, enablers of Amgen’s strategic imperatives, for example, patient focus and global presence.

“In 2009 a conventional facility was described as a 160,000 square-foot plant with $1 billion in capital investment and a 700 headcount. Now, it’s more flexible. It might be a 45,000 S/F plant with a $200 million investment and a 200 headcount,” he said.

“We started a plant in Singapore and it took half the time in construction and permissions, as compared to previous efforts. Single use systems were key to a flexible design in Amgen’s Singapore investment,” said Vedantham. The SUS means single use bioreactors, single use prep, hold and pool vessels, and a 95 percent reduction rate in surface areas that need to be cleaned, among others.

Vanessa Figueroa, a consultant for Quality Executive Partners, presented a new platform that is being developed to help associates within a manufacturing environment to understand the “why.”

She said with this tool you might be educated and trained to understand the “why” behind pharmaceutical manufacturing.

“A newcomer or even someone with repeated deviations can improve his/her subject by learning the techniques properly on a filling line, for example,” said Figueroa.

The Virtuosi technical courses will be 60 to 90 minutes long and will include a knowledge assessment at the end. You may learn more on aseptic techniques, air flow studies, environmental monitoring, facility cleaning, sterile testing or bacterial endotoxin testing, among others.