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Operation Excellence strikes again

July 9th, 2015 by

You’ve heard of it. You’ve probably experienced it. You may even have survived it. Yes, I am talking about “Project Operations Excellence”. Don’t get me wrong. The principles behind it are very good, even admirable. The premise is that we are operating presently as a result of processes that have evolved over time. A Band-Aid here, a Band-Aid there. The result is a set of processes that are inefficient not targeted to the customer and to be honest often counterproductive, sometimes counterintuitive. It does not sound good, does it?

Wouldn’t it be wonderful if we could deconstruct our processes and start again? That is what these companies sell you. The promised land of operations that are logical, lean (which brings me to another element of this concept, but I’m not getting drawn into that now – hint it suffers some of the same issues), lacking in superfluity, less is more, you get my drift.

So you sign on the dotted line and then in come the saviors. Most often it’s not the A team that did the sales pitch, the Dog and Pony show but if you are lucky it’s the C or D team. A couple of people who’ve seen the inside of an operations for a couple of hours together with a band of neophytes, fresh out of MBA school. They know the jargon, are excellent at powerpoints (I think that is one of the majors), the theory is at their command. Practical experience gained from case studies, that never go wrong.

Don’t I sound cynical and negative? No actually, I am not cynical or negative. I did not expect anything else. I’ve been through this exercise 5 or 6 times at different companies using some of the industry best companies and I’ve seen it at some of the companies I consult with. The problem is that we are our worst enemies. We do not challenge these saviors with data or facts or our experience. Just because they conclude something, does not mean it’s the best idea. It is an idea that should be considered. But often in these short 30 minute interviews to gather their data, they do not gather all the right information, they do not ask the right questions. Often it seems like they have gone in to these companies with the answer and are gathering data to support the results.

An example that came up recently, when talking with a client, related to an operational set up of a piece of equipment. On first glance, it appeared that after the equipment was set up, and then it was checked twice before using. The saviors immediately pointed out duplication and eliminated the second assessment. Nobody asked the question of why there were two checks. The junior person being interrogated did not have the answer. Voila, the step was removed. It was only afterwards, that a more senior person with experience of when the second check was put in place, that the explanation was clear. This piece of equipment had a tendency to drift in setting and the second check just before use was to monitor whether it had or not.

Perhaps the first check could have been removed? But that was never asked. An A team member with good process experience might have caught that one.

Modern day root cause analysis contends that silver bullets do not exist.  Rather it is a series of events (each incapable of causing the problem themselves) align and it is this alignment that causes the event.  So often we end up with corrective actions which are several to improve each element.

Is this example given an isolated incident? I contend no, because I have been into many companies reeling from these assessments. In fact one company that is in regulatory trouble now can trace their decrease in performance in operations, to an Operations Excellence episode. The results of the study were taken as gospel and implemented blindly. Clearly, all were at fault. An incomplete analysis, and accepting everything as correct etc.

So I caution everybody to think through how you manage an Operations Excellence project.

  1. Don’t assume that their answers are right – they are suggestions.
  2. They only get a snap shot of what is going on
  3. If you don’t ask all and the right questions, the answers may not be right.
  4. You are the ones who know what you do and why.

Remember that these people coming in to assess do their work and leave. They do not have to operate with what they leave. They are like a flock of seagulls, they fly in, squawking, leave you a present (hint, it is not paper) and fly off. What you should be looking for with an Operation Excellence is a team to evaluate, propose solutions and help you implement. And make sure you get the A team.

You thought the Indian companies were taking a hammering. Better look to the US Pharmacies

April 26th, 2014 by

In the first quarter of 2014, 3 Indian companies were issued warning letter (see my posting on the blog) whereas 7 pharmacies were hit.  Statistically significant?  Perhaps.

After the debacle of the New England Compounding Center about a year ago, the FDA has been on a rampage in the Pharmacy world.  I am no lawyer but the way I read it is the pharmacies are using a loophole in the law centered around the  issues of FDA jurisdiction.  FDA basically regulates interstate distribution of drugs, so make a drug in state X and “export” it to state Y – yep FDA has jurisdiction. So the manufacturers of drugs are under FDA rule.

Now, pharmacies are allowed to take these drugs and dispense prescriptions.  So when you go to your corner pharmacist, you can see them dispensing.  Counting out pills and putting them into bottles.  Hardly much risk here so long as they don’t muddle them up, get them cross contaminated  etc.  But they can also do further dispensing.  For instance, they can take a sterile vial or bottle of a drug and dispense it to another sterile container.  Now this is another matter.  What we are describing is aseptic processing.  As we all know that’s a risky business.  How many manufacturers fall foul of the regulations in industry?  The number of warning letters are numerous.

But it seems that FDA can not step in unless there is a demonstrated safety calamity.  But we don’t want to wait for that each and every time.  So what can the FDA do?  Their tack is to inspect these operations when they suspect that the Pharmacy has overstepped their authority.  It seems that in a majority of the 7 letter this quarter they have seen that the pharmacies have been dispensing these aseptically prepared drugs without prescriptions and compounding several drugs together.  Some of these drugs have different regimes of taking the drug.  Ergo, they are no longer dispensing, but manufacturing.

Now when they go in and inspect they cite for lack of GMP adherences and the story goes on.  Call me naive, but if I go to a pharmacy, I want an assurance that the drugs I am receiving are not adulterated.  I don’t care who regulates them but I want it done properly.  Clearly the Boards of Pharmacy have not been doing a good job (they are the ones who regulate at a state level rather than FDA).  What we have here is a standard clash between Federal and state control – we see it every day in other matters but in this case they are using our health as a pawn in the game.

 

Keep up the good work FDA.

He is the link to the 7 warning letters

Nora Apothecary Services ,  Lowlite Investments DBA Olympia PharmacyPallimed SolutionsWedgewood Village PharmacyTotal Pharmacy Services ,Avella of Deer ValleyVillage Fertility Pharmacy

 

Indian Companies get hammered in Q1 2014

April 1st, 2014 by

In the first quarter of 2014, there are 3 warning letters for Indian Companies.  Add to that the travails of Wockhardt and Ranbaxy over the last couple of years and it looks bleak for Indian Companies in general.  I regularly read LinkedIn Groups and I noticed a thread related the question of reliability of Indian Medicines.

Can We trust Indian  Drug Companies?

It created a firestorm of responses, many of which were from India.  The responses fell into three categories which I will paraphrase

1. The FDA is picking on us – EU and US companies have the same problems

2. I would never take an Indian medicine again

3. Indan regulators find no problem who is the FDA to tell us what our standard should be

1. Of course some US and EU and other country companies have run foul of the law. Actually there are over twice the number of warning letters directed to Pharmacies than Indian companies in Q1.  So maybe the FDA is picking on a broader range of companies.  Or putting it another way – they are doing their job and hard one it is.

2. Are all Indian companies bad?  Of course not.  I do not know the statistics but I have heard that 50% (and it could be higher or lower) of the US generics is from India and undoubtedly the major are fine (at least I hope so).

3. I am sorry but if you want to sell drugs on the US market you have to play by the rules here.  On paper, the Indian regulations are as tough as the FDAs but the question is detection of issues and enforcement that will separate the theory from the reality.

So what are the issues that are found

UVS issues appear to relate to data integrity.  Check my  previous posting on the blog .  The link to the warning letter is here

Smruthi Organics Ltd has a Warning Letter with only 3 observations.  One centered on data deletion, record destruction and inadequate investigations.  The link is here

Canton Laboratories Private LTD has a warning letter with 4 observations.  The essence is failure to keep data from testing, failure to actually test, failure to adequately clean equipment and failure to manufacture according to instructions and keep adequate records..  The link to the Warning Letter is here

In reality there is a lot of similarity in all these observations.  It does make one wonder about the quality of medicines.  Is this the tip of the iceberg?  Should I be worried?

 

Not just telling you your faults but how to rectify

March 30th, 2014 by

When I read FDA Warning Letters and I do often, most take the format of telling you the observations and then indicating that this is not a complete list. However, about 10% go one step further and basically read you the riot act suggesting that you need to hire a consultant to “educate you” on the errors of your ways. These are quite common.
But I believe they went to the next level for USV Limited of Mumbai. In the 2/6/2014 WL, they even listed out 7 steps for remediation. View this as reading the riot act 7 times over. Basically there was suspicion of fraud in the data.

The link is Warning Letter

They went on as follows
Get a consultant specialising in data fraud to do the following
1.) Identify the time period when the issue occurred
2.) Identify and interview employees involved in that period
3.) Identify and interview employees who have left who were employed during the period
4.) Gather data to support what comes out of the interview
5.) Trace issues to specific managers including senior management
6.) Determine if any other offending managers are in a position to influence data integrity decisions and expand your oversight
7.) Put into place procedures to prevent recurrence and assure there are no discrepancies between what was filed and reality. Create CAPAs to remedy issues. This does not apply simply to what we found but everything in essence.
Nothing revolutionary just common sense.

A new FDA Paradigm? Citing Guidances

February 28th, 2014 by

Just when you thought you had it straight, the FDA throws you a fast ball – or is it a slider, a spit ball. Not being a baseball fan, never quite certain what the saying is. Had I used the cricket analogy, I would have said a googly. But I digress.

Reading the new batch of FDA warning letters before my morning coffee, I came across an interesting paradigm breaker.

We all know FDA issues guidances and agrees to the ICH guidances. However, being guidances they are not law. That means that these documents and their contents are “suggestions” of practices they agree with. If you follow them they will give you no grief. They are really the path of least resistance. You can perform other practices and if satisfactory, you are OK. Just it might take more discussion during an inspection.

Now to the warning letter. It was issued to CBSCHEM Ltd of Hong Kong. In observation 1, they find fault in the traceability of the APIs. And which source of “regulation”?. The guidance ICH Q7 together with a hyperlink to the FDA website.

IS this the beginning of a new paradigm where they will cite Guidances?

Time will tell.