27.05.2015 |

LOGFILE No. 32/2015 – Older Pharmaceutical Factories

Older Pharmaceutical Factories – What does the FDA have to say?

by Thomas Peither

 

The problems older factories have to deal with are different from those of new ones. In this article the specific challenges involved are outlined. Questions on assessment are asked and approaches to finding solutions are given. The talk given by Sharon Thoma at the PDA Annual Meeting 2015 elucidates a topic that is on the agenda of many companies.

Old factories don’t have to look old.

Older factories can indeed exemplify the state of the art. This was the opinion expressed by Sharon Thoma of the FDA at the PDA Annual Meeting in March 2015.

However, all too often FDA inspectors also see older sites that are having problems with cGMP. The “c” in cGMP stands for “current,” up-to-date GMP. This means that a company should be using technologies and systems that correspond with the state of the art.

“Are your systems and equipment adequate enough to prevent contamination, to eliminate potential mix‐ups?“ Sharon Thoma asked the audience.

If systems and processes are convincingly applied, then an old plant does not have to be an obsolete one. The more fitting question that arises is whether a company has established appropriate processes. The processes must ensure that the plant and the processes always run at their best.

How can existing factories keep pace with time?

Ask yourself the following questions to discover whether or not your factory is still up to date:

  • Is your facility in need of a major overhaul or upgrade in order to meet todays’ standards of technology and compliance expectations?
  • Have you looked at your facility? Are there ways you could better maintain or upgrade your 10, 20, 30, 40... year old facility?
  • Have you conducted a quality risk assessment? Do you have appropriate controls in place to ensure there are no potential risks to product quality and ultimately, to patient safety?
  • Is it time to rebuild or install new technology / new equipment to protect products, meet current regulations, and to keep up with today’s demands? (e.g. RABS, isolators...).

Specific risks of older factories

Older factories nowadays are confronted with a wide variety of challenges, such as:

  • Inefficient processes
  • Inappropriate flows of material and personnel
  • Antiquated or obsolete ventilation systems
  • Old equipment that no longer meets current requirements

These groups of problems entail great risk or a high risk potential for GMP deficits. These challenges must be familiar to all.

The FDA focuses on older operations

Sharon Thoma quoted Janet Woodcock, CDER Director, to illustrate the FDA’s position on older factories: “Some inspections have found operations with antiquated or obsolete facility or process elements, and operations with high defect rates in violation of cGMP. These operations are receiving higher focus, while manufacturing operations that have been upgraded and are more dependable have been deemphasized.”

Production methods must be modernized. This action should be taken utilizing the progress made in operational and process concepts, such as:

  • Automating manual processes
  • Using closed systems
  • Integrating process analytical technologies (PAT)

Process monitoring can be improved in this way. The gateway to new manufacturing concepts should be found. These technologies help achieve the following goals:

  • Improving production reliability
  • Enhancing robustness
  • Lowering costs.

Summary

The FDA is well aware of the problems involved with older factories. Therefore, in the next few years the FDA will be watching these facilities. There are very many pharmaceutical manufacturing sites that not only meet current requirements; they are exemplary facilities. In her talk, Sharon Thoma described what to do to achieve these goals:

  • Always look for ways for improvement
  • Regarding technology, always stay on the ball
  • Continuously adapt the organisation to the changes.

In other words: Keep up to date!

Sources:

Sharon K. Thoma, CAPT/PRA, Aging Facilities – Inspection Trends, PDA Annual Meeting 2015, Las Vegas

Author:

Thomas Peither
Editor in Chief
Maas & Peither AG, Schopfheim, Germany

E-mail: thomas.peither@gmp-verlag.de

 
 
 

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