The SMRP Pharma/Biotech  Special Interest Group has made quick progress in establishing an active group of  industry mainteance and reliability practitioners.  With a full agenda of topics, the group met at Eli Lilly in Indianapolis in March 2012 and has followed up with bi-weekly conference calls.  The group’s active agenda includes fostering several sub teams focusing on:

• C&Q Links to M&R
• FMECA in Pharmaceuticals
• GMP Work…

Background

Over the past 5 years many forward thinking companies have invested in Manufacturing Execution Systems (MES) to enable electronic Batch Records (Bio/Pharma industry) and Medical Device History Records (Medical Device industry).  As these systems are built out, a logical integration point is between the MES and the CMMS.   The desire for linking asset information usually maintained in your CMMS directly with the MES is…

I had the opportunity to attend the Society of Maintenance & Reliability Professionals Pharma & Biotech Special Interest Group’s kickoff event in Indianapolis last week.  By the turn out of around 50 people it looks like this group already has some traction.  For those not familiar with the Society of Maintenance & Reliability Professionals Group (SMRP)  it’s worth checking out.

The Special Interest Group (SIG) for  the…

When examining the justification of automation investments there are tangible and intangible costs and benefits.  One of the most intangible, yet possibly the most important justifications for implementing a robust Calibration and Maintenance program at your facility is the cost of non-compliance to FDA Good manufacturing Practices (GMP).  In the first part of this series I listed the…

I’m often asked about Return On Investment (ROI) and the justification of automation investments.  One of the most intangible, yet possibly the most important justification is the cost of Non-Compliance to Good Manufacturing Practices.

Over the last 2 decades I’ve witnessed many companies come under heavy FDA pressure (i.e. Warning Letters & Consent Decrees) to remediate their Quality System compliance issues.  When this happens there are invariably substantial…

On Feb 2, 2012, I’m presenting at the NCSL International -Twin Cities, in Minnesota Winter Meeting.  The meeting is being held at Boston Scientific – Maple Grove and I’ll be presenting on Calibration and its Impact on GMP Compliance.  If you’re in the Twin Cities I encourage you to participate.

If you are not…

The recent Bio/Pharmaceutical Outsourcing Report article, FDA Increases Vigilance on Aseptic Processing Facilities does a good job describing the latest changes in the way the FDA is inspecting facilities.  This quote referenced in the article sums up the increase in enforcement activity - “Several years ago, FDA hired a large number…

Greetings in the New Year, thanks for helping us successfully launch the site, I’m pleased to see the activity.  I’m personally looking forward to 2012 and see that many others excited as well.

It’s hard not to look at the New Year and want to make some predictions.  There are certainly trends that will shape our lives in GMP asset management and our professional lives.  Here are the key trends I see continuing or gaining speed in 2012:

1) Higher GMP…

“Paperless” GMP calibration and maintenance systems became popular in the late 1990’s with the introduction of 21 CFR Part 11.  Now, demand for even higher levels of productivity and compliance are driving the resurgence in paperless systems.   The goal of any paperless GMP system is to facilitate gains in productivity while maintaining or increasing compliance.

Traditionally, compliance has come at the cost of productivity and paperless systems were seen as way to automate…

FocusOnGMP.com is dedicated to fostering an open forum for professionals in Pharmaceutical, Biotechnology and Medical Device industries to discuss, share ideas and to learn about GMP asset management.

In the 25 years I’ve been involved in GMP compliance, I have seen many trends evolve and take hold, but in GMP asset management none are more important or powerful than the trend to integrate the many management aspects of equipment selection, qualification, maintenance and…