Pharmaceutical Processing - Blogs

The Tale of Two Deviations

Mon, 23 Apr 2012 14:15:35 GMT

It stands to reason that pharmaceutical companies in compliance trouble also have problems with their Deviation Management and Corrective and Preventive Action (CAPA) System(s).

Can the Combination of Creative Destruction and “Steve Jobs’ Traits” Lead to a “Pharma QbD Spring”?

Thu, 19 Apr 2012 13:12:46 GMT

The answer is an unequivocal yes but we need some outsiders who can conspire with the insiders who will be the flag bearers within the companies. Outsiders can be the counsels/co-conspirators to the insiders for the coup d'etat.

Seven Success Criteria for Hiring (and working with) a Good GMP Consultant

Mon, 16 Apr 2012 12:38:24 GMT

The high layoff numbers in the pharmaceutical industry and poor job prospects in a weak economy have flooded the market with would-be consultants to pharma companies that need extra help. Here are my suggestions for hiring and working with a good GMP consultant.

Epiphanies – Disclose at Your Discretion

Fri, 06 Apr 2012 17:17:21 GMT

I’ve recently come to the conclusion that there are two kinds of epiphanies – the kind you like to brag about and the kind where you look around and say to yourself, “Am I the last person to figure this out?”

Let Bygones Be Bygones? Not So Fast

Mon, 26 Mar 2012 13:37:44 GMT

It seems that as humans, we are excellent at “temporary learning”: The art of correcting potentially reckless behavior after some event shakes us up, but then quickly reverting to our careless ways.

Antibiotic Activism

Thu, 22 Mar 2012 18:35:43 GMT

I’m a big fan of those web stories that list 10 things your (insert name of profession) won’t tell you. From waiters to flight attendants to nurses – I’ve read them all – and most of their insights are not pretty.

Correlation is Not Causation

Thu, 22 Mar 2012 12:20:40 GMT

Seeking and finding correlations – co-occurrences between two or more factors – is a key tool in the root cause analysis arsenal. It can lead you to possible causal factors to investigate.

Just Business?

Mon, 19 Mar 2012 19:21:05 GMT

I typically use this space for talking about industry issues, offering my views and opinions on recent developments such as recalls and the recent drug shortage crisis. To me, that is just one side of the industry.

Neglected Tropical Disease (Infectious Diseases) Drugs: What are they telling us about Innovations!

Thu, 08 Mar 2012 13:22:37 GMT

During my career I have been involved in process simplification and cost reduction of different chemistries, chemicals and processes. When I am discussing any process, my mind always races to understand its chemistry, manufacturing process and how the cost can be lowered and the profit improved.

Beyond Compliance: Using cGMP Compliance to Improve Business Results

Mon, 05 Mar 2012 13:38:34 GMT

Which organization is more like yours? FDA regulations will choke our business or compliance audits provide useful insights about what we can improve.

J&J: Out from the Ashes - Not

Mon, 27 Feb 2012 13:45:11 GMT

Johnson and Johnson gutted and retooled their Fort Washington facility to come back with a bang with the launch of a new bottle designed for its grape flavored infant liquid Tylenol to guard against accidental overdosing. But instead of accolades, complaints poured in about the protective cover pushing loose when the dosing syringe was inserted.

Drug Shortage: A Story of Self-Inflicted Management Tragedies

Mon, 13 Feb 2012 20:09:00 GMT

My blood boils when I read an article such as the one that appeared in the New York Times entitled Supply of a Cancer Drug May Run Out Within Weeks, by Gardiner Harris. This is one of many articles that has appeared lately about the mounting crisis of drug shortages across the country.

When Is Software The Answer To Regulatory Concerns About Your Investigations?

Mon, 30 Jan 2012 17:01:53 GMT

Document management software enables investigators to present the information used to reach conclusions clearly and concisely and it helps reviewers to track and approve investigations.

The Benefits of Professional Project Management

Fri, 13 Jan 2012 20:07:21 GMT

Some companies feel that they can project manage new processing facilities themselves, bringing in sub-contracted help only when it’s needed. Self-managing is possible, but there may be a better way.

New Year - New Recall

Wed, 11 Jan 2012 16:36:27 GMT

It’s only a few weeks in to the New Year and it’s sad to say that 2012 is already shaping up to be as bad as 2011 was in regards to pharmaceutical product recalls.

Happy Refurbished Year!

Mon, 09 Jan 2012 14:30:19 GMT

If you are willing to put in the effort, savings can be found in every arena — you can even find ways to save money on manufacturing equipment.

New Years Resolutions for Pharma Quality Assurance

Tue, 03 Jan 2012 13:19:29 GMT

Like anyone else, coming to the end of the year brings a time of reflection and anticipation. I look back and ask the question, "Have I made a difference in anyone's life?" I look forward and ask, "What do I want to change that I either have control or can influence?"

Drugs for Infectious Diseases, Funding and Opportunity

Mon, 12 Dec 2011 15:32:27 GMT

Spread of infectious diseases such as HIV/AIDS, malaria, schistosomiasis, and tuberculosis are cause of a global concern. Pharmaceutical companies have and continue to develop and market drugs that are effective for their cure.

FDA and EMA Pressures - Are Agencies on the Defense?

Thu, 01 Dec 2011 13:18:09 GMT

With imports of pharmaceuticals to the U.S. on the rise and criticism of the U.S. Food and Drug Administration (FDA) that it has not inspected foreign plants with any regularity. The FDA is clearly on the defensive.

Does the Pharmaceutical Industry Need a Steve Jobs?

Thu, 10 Nov 2011 13:32:26 GMT

A little over a month ago Steve Jobs passed away and tributes that have been forthcoming are breathtaking. This is in spite of his early career shortcomings. Besides creating amazing products he was a “simplicity” genius.

“ITS BACK”: The Dilemma of Recurring Problems

Tue, 08 Nov 2011 18:56:14 GMT

Nightmare scenario: The phone rings and you learn with dread that the problem you thought you had gotten rid of a month ago is back and bigger than ever.Your stomach sinks and your pulse quickens, as you scramble to find out exactly what is happening. AND you know it is only a matter of time before plant management will be showing up at your door to have a “serious” discussion.

Tools That Improve Outsourcing Selection

Thu, 03 Nov 2011 12:40:12 GMT

With big pharma and biotech companies looking to cut costs and optimize their spending, the methods used in outsourcing partner selection are more relevant to the industry than ever before.

KT and Six Sigma – Complementary or Competitive?

Tue, 01 Nov 2011 19:29:22 GMT

We often run into discussions with clients about whether the KT problem analysis process fits in with the Six Sigma work they are doing. Their questions are usually posed to cast the two techniques as being in competition with one another; it’s almost as if they feel they only have the capacity to use one tool, so which one should it be?

Top Ten Ways to Make GMP Training Relevant

Thu, 27 Oct 2011 12:34:36 GMT

Most GMP training that I encounter is not necessarily bad--just irrelevant. In fact the same could be said for the Training Department. They jealously guard their turf and deliver mediocre, perfunctory training. Names get checked off the list, and the Training Department goes about their business being irrelevant. (Ouch!)

Drug Shortages: Causes and Cures

Thu, 03 Nov 2011 15:49:47 GMT

Lately we have been reading and hearing about the shortages of many drugs. As a matter of fact, the US FDA on a routine basis publishes a list of drugs that are in short supply. Families and doctors of patients who need these drugs have a cause for concern. Hospitals, where some of these drugs are needed, have become creative in determining what possible approved substitutes could be used.

How to Tell if You Have the Right Root Cause: A Short-Cut

Thu, 13 Oct 2011 12:27:57 GMT

At Kepner-Tregoe we do a fair amount of problem solving facilitation. A client will call us up and say, ‘We’ve got this problem, and we’ve been working on it for months, and we still don’t have a consensus on the cause. It’s gotten so bad that you can’t even ask a question without getting into a political fight. Could you send someone who can take over the analysis and act as an unbiased analyst, with a cold clear eye?’

Beyond Logging Complaints: Using Effective Customer Service to Improve Business Results

Fri, 30 Sep 2011 12:21:28 GMT

How does your organization view customer complaints? Most companies do not readily welcome them, but, if handled well, customer complaints can be a significant source of information, helping to control costs and actually enhance customer satisfaction.

How Far Does Annex 11 Go Beyond Part 11?

Mon, 19 Sep 2011 12:20:03 GMT

The Food and Drug Administration’s (FDA) Part 11 (21 CFR Part 11) and the European Union’s (EU) Annex 11 (EUDRALEX) Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice (GMP), Medicinal Products for Human and Veterinary Use) share the same intent. Namely, all computerized systems used in GxP-regulated environments require compliance for ensuring integrity of records and data. Annex 11 moves beyond Part 11 for some obvious reasons – time and approach.

Nice Insight: Connecting CMOs and CROs and Big Pharma

Wed, 07 Sep 2011 17:39:51 GMT

After working for 2 years as the Global Director of Strategy and Marketing for a Contract Manufacturing Organization, I saw a gap in the way CROs/CMOs engage with Big Pharma and Biotech companies in outsourcing projects.

The Fallacy of People Problems and How to Resolve Them

Fri, 02 Sep 2011 16:42:43 GMT

One of the most often cited statistics in pharmaceutical manufacturing is that 80 percent of all reportable deviations are “people problems,” deficiencies of human performance.