On Wednesday 3 March the EMA published a draft CHMP Guide on Real-time Release and a Concept Paper proposing a revision to the CHMP Guide on Process Validation.  These documents can be seen at http://www.ema.europa.eu/pdfs/human/qwp/81121009en.pdf and http://www.ema.europa.eu/pdfs/human/qwp/80911409en.pdf respectively.  The Concept Paper on Process validation makes no mention of any possible revision of Annex 15 of the EU GMP Guide, which also is in need of revision in order to introduce the concepts of Quality by Design and risk management.  These two documents show that the EMA are now moving in the same direction as the FDA on these related topics, all be it about a year or more behind them.

In early March 2010 the FDA released a new Guidance for Industry document on “Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications”.  This new Guide can be found at http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM202439.pdf

The UK’s Pharmaceutical Quality Group (PQG) has launched a guide on Supply Chain Risk Management.  This is a very good document that is available as a free interactive pdf.  Whilst it is aimed at supply chain risk management it also has a lot of very good general content on pharmaceutical quality risk management.  For more information on this guide and to download your free copy, go to http://www.pqg.org/publications/riskmanagement/index.php

Please find attached a document relating to the new EU Variations process as set out in Regulation 1234/2008.

The EU has published revised GMP guidance for Investigational Medicinal Products which was adopted by the European Commission on 31 January 2010 and published on 03 February 2010.  The deadline for coming into operation is 21 July 2010

• The revision reinforces the principle of independence between production and quality control functions in cases where the number of personnel involved is small.
• Changes to sections 36 and 37 supplement for investigational medicinal products, the guidance for reference and retention samples given in Annex 19.
• An additional note has been introduced to clarify the meaning of “reconstitution” as referred to in article 9.2 of Directive 2005/28/EC.
• The content of the Batch Certificate referred to in Art. 13(3) of Directive 2001/20/EC, agreed following a separate public consultation, has been added as an attachment.
• A few editorial changes have been made to sections not consulted upon in the interests of updating references and consistency with terminology used throughout the GMP Guide.
  
  

For a revised version of Annex 13 please click ‘more info...’.

Every day we all make thousands of decisions from the route we take to work to what we will eat for dinner.  At work the decision making continues a pace:

·         ‘Should I release or reject this batch?’

·         ‘Do we use supplier X or Y or..?’

·         ‘Where do we focus our limited resources?’

·         ‘Do I approve or reject this change request?’

·         ‘We haven’t identified the root cause of this deviation…what should I do?’

Toyota: Poor Decision Making in Practice?

Three years ago Toyota we’re riding on the crest of a very big wave.  They were seen as the best of the best, following decades of unprecedented growth and profitability.  How quickly things change!  Following massive recalls and chronic manufacturing problems city analysts, industrialists and loyal Toyota customers have been left wondering… what has gone wrong?  Although the jury is still out, one thing is for sure; along the way some very poor decisions were made by intelligent, experienced people throughout the organisation.  

The same can be said for some pharmaceutical companies where ‘ill informed’ decisions are costing them a fortune in rejects, reworks, repeat deviations, customer complaints, even recalls.

Companies in trouble with regulatory agencies have one thing in common…poor decision making from the top to the bottom.

Good Decision Making: What does it take?

Good decision making used to be seen as an ‘art’ rather than a science.  Something that came with ‘experience’!  Well, we now know that decision making is a skill that can be learnt and, with practice, dramatically improved.  Thanks to advances in brain research, we now know what happens between our ears when decisions are made.  The accuracy of our decision making can be improved by education and training providing we follow some very basic rules and break old habits

Decision Making: Did You Know….

·         It’s a fallacy to believe that decisions are made analytically, objectively weighing up the pros and the cons and making a completely ‘fact based’ decision.  Even scientists don’t do it.  We weren’t designed to be rational creatures.  Emotions play a bigger part in decision making than the facts and the figures. It’s not surprising that most people take the view ‘If it feels right, it must be right.’

·         Although we often make decisions based on ‘gut feel’ these are often wrong.  The emotional brain is vulnerable to some innate flaws.  In some cases the emotions we depend on to make decisions can actually sabotage common sense!

·         Unless you have a structure and discipline to your decision making you could end up in trouble.

·         Our brains are actually designed for fast, not accurate decision making  

·         Our brain actually has 2 thinking systems, one rational and the other emotional.  The skill is knowing which one to use, and when

·         That part of our brain responsible for logical analysis actually has very limited capacity.  In fact it struggles to deal with any more that 7 ‘bits’ of information at any one time.  It’s not surprising we get confused quickly; too much information can overwhelm our logical thought process.

·         You can compromise your decision making by having too much data.  You must look at data selectively.

·         Risk aversion can lead to the wrong decision. When you next do a risk assessment remember,  ‘playing safe’ may expose  you and your companies to greater risk

·         Your brain was never designed to make the right decision when exposed to stress…only a very quick one.  Stress and fatigue tends to over simplify things so when stressed avoid making really important decisions…unless you’re happy with it being wrong!

·         One of the best ways of improving your decision making is to forensically examine your mistakes. If you don’t your are likely to repeat the error

·         On average most of us use less than 5% of our intellectual capability. Just think how much your career would benefit if you used the rest?

How to dramatically improve your decision making:

Although evolution may not have provided us with the best decision making brain you can, with our help, improve the accuracy and reliability of your decision making, no matter how tough the decision.

Our course on ‘Risk Based Decision Making’ will provide you with the following:

·         A simple  understanding of how your brain makes a decision, based on the latest research

·         A structured approach to decision making that is simple and fast.  We will provide you with the skills needed to make the right decisions by showing you:

·         How to gain sufficient understanding of any ‘situation’ before making a decision

·         How to avoid ‘data overload’. Remember, your brain can’t cope! It’s not the quantity of information that matters, it’s the quality that counts

·         How to control your emotions….gut feel is often wrong

·         How to generate alternative options and solutions

·         How to assess and manage risk, quickly and accurately

·         How to use simple tools and techniques to use the remaining 95% of your intellectual ability!

·         How to make good decisions!

·         Importantly, this highly interactive course will provide you with the opportunity of practicing these skills until they become habit.  

To improve your decision making skills you have one of 2 options. You can come to us or we can come to you! We have courses scheduled at the following locations (PDFs attached)

Risk Based Decision Making

Marriott Philadelphia West, West Conshohocken, PA, USA

23 – 25 March 2010

OR

Risk Based Decision Making

London Marriot Hotel Kensington, UK

19 – 20 October 2010

If you can’t come to us, don’t worry we can come to you!

Alternatively we can come to you and educate you’re entire team, not just selected individuals. Running the course ‘in house’ can have many benefits…

·         It can be cheaper and more affordable. We can train more people for less

·         Case studies used can directly reflect the experience of your workforce

·         You all get the same education at the same time, creating an unstoppable momentum for change

·         Your problems and challenges can be openly discussed in a confidential environment!

If you would more information on running a customised in house course please just contact Martin Lush (mkl@dba-global.com)

So, when you are agonising over the next decision remember it doesn’t have to be that way. Just give us a call