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cGMP Compliance is Pharma’s Top Manufacturing Goal, Preliminary Survey Results Suggest

10/17/2012

By Agnes Shanley

So far, 75 people have responded to our latest mini-survey on manufacturing excellence and goals for the year.  Of these respondents, 45 answered every question in the brief survey.  The results, while not statistically important, still suggest some trends. 

What follows is a quick summary of interim results.  The survey will remain open, and we invite you to take three minutes to complete it (we are also offering a nominal incentive.  To take the survey, or more information, visit http://www.surveygizmo.com/s3/1040818/Pharmaceutical-Manufacturing-Operational-Excellence-Survey-2012)

When asked whether manufacturing operations were becoming more complex. 22% of respondents said complexity had increased significantly.  Nearly 48% said they had become “somewhat more complex.”  Nearly 27% said they had remained unchanged, with around 3% saying they had become less complex.

When asked to rank their priorities in order of importance, the following weighted priority list took shape:

Improving GMP compliance
Boosting efficiency
Improving product quality
Reducing cycle time
Reducing setup and changeover time
Reducing waste
Improving scaleup
Increasing agility

Top pharmaceutical product quality goals were as follows, ranked in order of importance:

Eliminating variability in final product
Improving raw material quality
Improving supplier oversight
Reducing scrap time

When asked whether their organizations had methods in place to assess the cost of poor quality and noncompliance, over 64% said they did, while the remainder did not.

Respondents ranked their most strategically important Op Ex methods as follows:

Statistical Process Control
Process Capability Analysis
Lean
Six Sigma
DOE
5S
PAT
QbD
OEE

Several years ago, manufacturing was described as a "stepchild" function at many companies, and a few survey questions probed this area. When asked how important manufacturing was to their organizations’ overall business strategies, over 62% said it was very important, with 24% responding “important,” 11% “moderately important,” and the remainder not important.

Survey responses also suggest that manufacturing is working more closely with both development and quality control functions, suggesting that more pharmaceutical manufacturing facilities, and companies, may be moving away from traditional silos and adopting a more crossfunctional approach to daily operations.

Nearly 76% of respondents said manufacturing was working “much more closely” or “more closely” with development.  84% said that manufacturing was working more closely or much more closely with QC functions.

In addition 78% said that top managers at their organizations came from the manufacturing function.