Updates - Thinking Ouside the GMP box

Following on from my last post I've identified another issue to be aware of surrounding relevant legislative updates.


Outside the Box

Recently I have come across a new EU directive that will likely have an impact to my processes.  Although not the most recent update, directive 2010/32/EU comes into force within the UK on 11th May 2013 via the Health & Safety Regulations 2013.

Before you start rushing to re-check your lists of GMP & EU directive updates, 2010/32/EU has nothing to do with GMP, QP duties, API imports or falsified medicines.  The aim of this directive is for the prevention of sharps injuries in the hospital and healthcare sector and one of the main recommendations is that needles must not be re-sheathed after use.  This directly impacts some of our processes where we currently re-sheath needles during small scale aseptic manufacture to minimise contamination risks of the exposed needle. 

Luckily the transposition into UK law has not been word-for-word.  The UK regulations state '...re-sheathing must not occur unless justified by risk assessment....' whereas the original EU directive text states '...the practice of re-capping (re-sheathing) shall be banned with immediate effect....'.  Therefore the UK regulations provides some 'wriggle room' to continue to re-sheath providing this is justified via risk assessment.  Now this is unlikely to come under the remit of GMP inspections but Hospital Trusts within the UK do get audited by the Health & Safety Executive and hence may request to view these risk assessments at some point in the future.

I realise that this will not have a direct impact to commercial QPs but I wanted to raise it for the following reasons:

1. To ensure you are aware of all legislative updates that may affect your practice, not just GMP related ones -cast your net far and wide.  
2. Legal duties '..products manufactured & checked in accordance with the laws in force in the member state...' therefore covers all types of legislation within the UK (including Health & Safety Law) 
3. An example of how EU directives are not always transposed word-for-word into UK law.
4. For an awareness of other areas of practice within pharmaceutical manufacturing
5. The importance of knowing your manufacturing processes

Summary

During your viva I think it is important to know the all the important GMP updates and these would be first on my list - (i.e. my first layer).  However, I also believe that being able to demonstrate an awareness of other legislation that has a direct impact to your area of practice will score some points with the assessors.  Anyone can learn all the updates parrot fashion but is that really what the assessors are looking for? 

I hope this illustrates that keeping up-to-date is not just about GMP updates.  Yes, those are extremely important to both trainee & qualified QPs but you still need an awareness of those legislative updates outside the GMP box.  Your legal duties as stated in Article 51 clearly state that each batch needs to be manufactured in accordance with the local laws of the member state.

Another interesting point for another post is that Schedule 7 SI2012/1916 doesn't refer to 'local laws' only 'these regulations' ie only the Human Medicines Regs 2012.  Do you therefore need to comply with Health & Safety legislation...?  Do let me know your thoughts on this

Study Toolbox Part 3: Keeping up to date

 The 3rd instalment in the Study Toolbox series will look into the best ways of keeping up to date with the ever-changing field of GMP and pharmaceutical legislation.  This is important not only for your viva but also throughout your QP career.  There is also a requirement for continuing professional development (CPD) once you become a member of one of the joint professional bodies.  Therefore keeping up to date will also help maintain your CPD to keep your professional regulator happy!

 One of the most commonly asked questions in the QP viva is regarding GMP updates.  This question is usually asked towards the start of the viva in order to provide a 'soft' question to help settle your nerves and get you on track for the more meatier questions ahead.  The question may be phrased open-ended, eg 'what are the recent GMP updates?' or 'What recent updates are relevant to the QP?'  Specific questions are more likely to be asked as a follow up to one of your previous answers, eg 'you mentioned the FMD directive, please explain'. Therefore you will need to have a good overview of recent updates but also be able to have more layers/details for specific updates relevant to QPs. 

Tools for keeping up to date

1. RSS  Feeds

My main tool for monitoring updates is via RSS feeds.  You'll need a RSS reader such as Google Reader to provide a viewable platform for the incoming feeds.  RSS feeds are typically linked to websites and once the story is published the link gets sent straight to your reader.   This provides a useful way of skimming through all your favourite websites without having to trawl through each website in turn.  Most websites will have an orange RSS symbol within their news section.  Clicking on this symbol will provide a direct link for your RSS reader.

Occasionally you will receive updates via RSS before the website has been updated.  For example, the recent updates to the chapters within Eudralex Vol 4 is not (yet) listed on the Eudralex section of the ec.europa.eu website.  Thanks to my RSS reader these updates found their way to me and can easily be retrieved by searching within my RSS reader.  If you were only looking at the Eudralex website you may have missed these crucial updates to GMP.

Google Reader detailing my Pharmaceutical updates section

Google reader is also available as a mobile app which allows you to sync your reader account to your smartphone/tablet for access during those long commutes on the train.  Most RSS readers can also incorporate your favourite blogs which will send new posts to your reader as soon as they are published.

My top sources for RSS feeds:

MHRA
EMA
FDA 
ICH
Eudralex (ec.europa.eu)
European Federation of Pharmaceutical Industries & Associations (EFPIA)
RAPS Regulatory Exchange
GMP Publishing
European Compliance Academy (ECA) 
Pharma IQ
Royal Pharmaceutical Society
World Health Organisation
International Organisation for Standardisation (ISO)



  2.  Email Alerts

Email alerts are also a great way of keeping up to date.  Most of the main players in the Pharmaceutical/GMP arena have email alerts you can sign up to.   The emails can come flying in thick and fast and I would recommend setting up a dedicated email address for this if you don't want your regular inbox becoming inundating and messing up your hectic social life.  

Signing up for the MHRA drug alert emails is particularly useful.  Not only are the alerts emailed instantly but they are a really useful source for potential scenario-based questions and to get an good idea of what types of defects/errors make up the different types of drug alert classes.  The FDA's warning letters (483) provide a great insight into serious GMP inspection findings for sites both within and outside the United States.  

My top sources for Email alerts:

FDA
MHRA
European Compliance Academy (ECA)

3.  Twitter

I am only a recent convert to Twitter but have found it useful for providing information and links to websites & articles that you may not have originally thought of.  Twitter lends itself well to the mobile platforms due to the (mostly) text only interface.

Again, all the main culprits have twitter accounts such as MHRA, EMA, RPS etc but I tend to use Twitter for following specialist individuals as opposed to large organisations.  These specialist individuals usually dont have the resources for setting up RSS feeds or comprehensive email alerts systems and hence I let my Google reader account take care of information from the large organisations.  When you find someone to follow it is always worth looking to see who they are following themselves.  This will likely increase your scope and identify further people/organisations to follow.

These are some of the useful active accounts I'm following:

@PharmaIQ
@QPQuandary
@AlecGaffney
@PharmaNews
@BioPharmIntl
@Inspiredpharma
@PharmTechGroup
@EURlex


3.  Other Social Media & Journals

There are quite a few additional sources available to you.  Facebook, journals, blogs, LinkedIn to name but a few.  I tend not to rely on these for providing updates to relevant GMP/legislation/guidelines.  I've found these sources to be more useful for general information, networking and job hunting!

I still like to occasionally browse some of the high impact journals surrounding subjects that I have a personal interest in.  These include; Cancer Cell, Cell, Nature Cancer Reviews, Science & NEJM.  These obviously wont keep you up to date with the latest GMP developments but will provide background knowledge to scientific progresses in disease states relevant to your particular dosage forms.  This background knowledge may also help prepare you for what is to come in the future with regards to novel treatments - they'll all hopefully need QP certification one day!


Using MindMaps to manage updates

Throughout your QP training there will be a number of important updates that you will need to remember for your viva.  Certainly in the last 6 months there has been enough GMP updates to keep us all busy.  The QP assessors will likely expect you to not just list all the updates but provide detail on updates that are relevant to your current practice.  With each new update you can amend your mindmap to reflect the changes and doing this as you go along should help reduce the burden once you get closer to viva day.

My constantly evolving updates Mindmap. 

The image of my mindmap above shows the outline of all the relevant areas of updates that I feel I should be aware of.  I haven't included FDA updates within my own map as my current area of practice does not include any drugs marketed in the USA.

2nd & 3rd layers of updates mindmap showing GMP updates. 

As mentioned in my previous post mindmaps are a really useful tool for providing layers of details to particular subjects.  GMP updates is a good example of making the most out of mindmaps.  The image above has focused in on GMP updates and the first layer is detailing the relevant years.  I doubt you'll be expected to know the explicit details of updates going back 5 years.  I've only gone back to 2008 because this was the last major update of Annex 1 and Sterile products will be my specialist dosage form.

3rd, 4th & 5th layers of updates Mindmap for the chapter 5 update in 2013.  The layering technique is hopefully clear from the image above. 

Summary

GMP & legislature updates are an important part for both your viva and for your future life as a QP.  We are lucky to live in such an electronic age where all relevant updates can be immediately disseminated throughout the QP community.

Taking advantage of the available tools mentioned in the post should help these updates find you as opposed to you going out hunting for them. 

Study Toolbox Part 1:  The Onion
Study Toolbox Part 2:  Introduction to Mindmaps

Roles of the Sponsor

One of the most important people in the process of becoming a QP is your sponsor.  Your sponsor should provide you with a wealth of knowledge & experience and a passion for their work.  The sponsor is not just someone who signs your application form at the end of the process!







Sponsor Requirements

your sponsor must be a member of one of the 3 professional bodies (RPS, RSC, SoB) and should be a practising Qualified Person.  In practice it is common that your sponsor will be your line manager.  This is preferential as they will already know your previous experience and be regularly available for discussions and reviews.  A line manager who is not a QP may act as your sponsor as long as the application form is counter-signed by a QP performing duties under the license to which you are engaged.

The role of the Sponsor should not be taken lightly as the role carries significant responsibility.  The QP Guidance Notes issued by the joint professional bodies gives a comprehensive list of roles & responsibilities of the sponsor and is well worth a read for both QP trainees and sponsors alike.

Sponsor Form

The sponsor form will form part of your completed QP application package to your professional body.  The QP sponsor form was comprehensively updated in 2013 to ensure sponsors are fully integrated into the trainee QP's training.  The updated form also gives the sponsor more documentation to complete prior to submitting the trainee's application form.  Sponsor's will have to provide examples of occasions where the trainee QP has met a number of competencies.

So, what should you look for in a potential sponsor?  Here are some of my sponsor tips (in no particular order) from my limited experience with working with my own sponsor:

1. Share an office

It helps if your sponsor is based in the same office.  Not only for ease of training sessions but also working alongside them to gain a practical, hands on appreciation of life as a QP.  Close proximity allows constant firing of questions from the sponsor to trainee.  My sponsor will often ask my for QP legal duties at random times.  After a while they become second nature and I can now recite them on request!

     2.   Allocate time

Allocate time for regular meetings each week.  These should review your current training topics, application form, planned visits and work diary.  Having some structure to these meetings helps to make use of the (usually limited) time available.  Set objectives & goals for the next meeting to ensure you can target your study topics effectively.  Making the meetings formal, for example by scheduling in Outlook is a great way of keeping the meetings.

     3.  No sugar coating

Your sponsor needs to be honest with you.  If you answers to questions or knowledge around a specific area is lacking then they need to tell you.  There is no point in pretending all will be fine come viva day as you'll need toughening up before meeting the 3 assessors in your viva.  Obviously constructive criticism works best and the trainee needs to be receptive to this.  Taking the mickey is acceptable if your answers are daft enough.....

     4.  Old school Vs New school

I think it really helps having a sponsor who has gone through the viva as they should know what it takes to train someone to pass.  Grandad & transitional QPs have not gone through the viva process and, to me, would appear not to be in the best position to prepare someone for a viva they haven't sat before.  Ensure your sponsor is up to date in all recent GMP/legislation updates as you will need to be tested regularly on this area as this is sure to come up in the viva.

    5.   Well networked

Your sponsor should be well networked within the QP community.  I haven't met one that hasn't been well networked yet - even in the NHS!  Having contacts is particularly important to help arrange industry visits to cover areas/dosage forms and provide introductions to other trainee QPs for potential study partners.  It is important to create these networks yourself in order to get different opinions from your sponsor - your sponsor doesn't always know best!  (only your mum does)

     6.   Involved in QP trainee recruitment

Having the sponsor directly involved with the recruitment process will ensure the applicant's understanding of the level of commitment required throughout the training period.  As a sponsor you will also need to be able to communicate effectively with your trainee and being on the interview panel will provide an insight to the candidates personality.

    7.   Supportive

During your QP training you will have ups and downs.  There will be times where your confidence soars around particular topics and other times where you feel you cannot see the woods for the trees.  Having a supportive sponsor who knows how to recognise these signs will help you to get through the bad times and keep you grounded during the highs.  They should also understand to recognise when you've had enough and need a break for a week or 2 as the training can quickly become all-consuming.

    8.   Prepared to be challenged

As the trainee gains knowledge and experience the sponsor should be expected to be challenged from time to time.  The sponsor needs to encourage this to develop the debating skills in the trainee which will be needed not only in the viva but as performing their QP duties in the future.

    9.   Get the rounds in

You need to get along with your sponsor as you will likely be spending considerable time with them throughout your training.  Having common interests outside of the GMP-world is beneficial and enjoying each other's company over a beer or 2 always helps.

    10.  Keep them sweet

When you finally pass your viva make sure you find a suitable way of thanking them (be creative).  Don't piss them off and leave the company straight after gaining your QP status!  That is likely to leave a sour taste in their mouth - remember, the QP world is small and well networked!!

 

I've been really lucky with my sponsor.  We were friends before even starting the QP training and are of similar age which helps with the working relationship.  More importantly, he has only recently passed the viva so all his knowledge is still lodged in his head (for now at least). 

Study Toolbox Part 2: Intoduction to Mindmaps

Part 2 of the Study Toolbox series looks at the use of mindmaps to develop your knowledge and more importantly to hone your technique for delivering those perfect answers during the dreaded QP viva.  


I had never heard of mindmaps prior to starting my QP training.  It was my sponsor who introduced them to me (they do have their uses) and I have now incorporated them into my daily study schedule.
 
What are Mindmaps?


As usual, Wiki provides a great overview of the basics of Mindmaps.   Mindmaps are diagrams used to visualise all links, ideas, words & concepts around a central, single topic (think brainstorming).  They can be handwritten or designed with dedicated software.  They are particularly useful for problem solving & condensing information into layers (remember the onion analogy?) - two attributes that lend themselves to QP training.


Manual Mindmaps

I've found that manual Mindmaps are useful for outlining all the branches & layers surrounding a particular topic or question before transferring to a final electronic copy.  Mindmaps give you and your brain the freedom from the 'fit on the page' mentality as mindmaps can go on and on forever and link with other mindmaps to create a multitude of maps to really free your mind.  Obviously the electronic versions are really only capable of this, unless you have an abundance of A1 paper laying about the office.

 Electronic Mindmaps

There are a number of software providers willing to take your hard earned cash for their software.  Luckily, if you are a skinflint like me, there are a few free versions out there and most provide a free trial which if you are clever, can 'extend' unofficially.  Ive tried a few different programmes and here are my thoughts:


1.  Mindjet

This is my go-to software for generating mindmaps.  Mindjet offers a cloud based portal for electronic storage of your mindmaps.  This is great if you like having access to your mindmaps from any PC and are wary of your laptop crashing and loosing the data forever.  For those willing to pay the annual subscription, Mindjet gives you the option to export to .pdf  or .doc etc to provide an off-line back up system.  Your PC will need Flash installed to view the mindmaps.

After 6 months of use Mindjet has grown on me.  The convenience of cloud storage, no limit to the free trial and expandable/collapsible branches are particularly useful to me.  The expandable/collapsible branches helps in preparing responses to your viva questions - I'll post on this separately soon.  The advantages outweigh the sometimes clunky interface which can occasionally crash causing loss of data.  However,  this has only happened twice in my time using it.

I have also found a way to edit off-line using Mindjet.  The Mindjet android app allows you to edit or create mindmaps off-line and once back on-line the app will sync with your mindjet account.  Accessing your mindmaps from the convenience of a tablet computer or smartphone is very convenient and would highly recommend it especially for those who commute by public transport.

2.  iMindMap

This is my sponsor's mindmap of choice.  iMindmap offers the option of desktop and cloud storage of mindmaps as well as free 7 day trial before you commit.  It functions as per the usual mapping software but allows you to drag topics from the central theme using the mouse.  The free version does not allow you to collapse or expand branches - this is where Mindjet has the advantage.  One of its selling points is that it has been developed by one of the founders of mindmaps (Tony Buzan) and it uses bright colours in default setting to really get both sides of your brain firing.

The only reason I didnt continue with iMindMap was due to the lack of the collapsible/expandable branches on the free version and the 7 day trial limit.


3.  MindMeister

I only tried this free android tablet app for a few minutes before its annoying user interface and lack of undo function drove me to hit the uninstall button.  From my experience there are far better mindmapping software out there.


Mindjet Example

The example below is from my own bank of Mindjet mindmaps.  The map contains basic lists to learn for the microbiology module.  I've zoomed in on Rapid Methods to show how I have constructed the map to provide an overview (3 subtopics) and further layers with increasing detail - again picture those onion layers.

Example of Mindjet mindmap.  '+' symbols indicate expandable branches

1st layer from sub-topic

All additional layers from one sub-topic

There are numerous other mindmap applications out there and I have really only touched the surface here.  For your first foray into mindmaps I would highly recommended downloading the trial versions to either your laptop or tablet and having a play around with them - I'm sure you'll be hooked in no time at all!

I plan to write a post on a specific viva question and how I would use a mindmap to construct a logical & polished answer. 


Study Toolbox Part 1:  The Onion
Study Toolbox Part 2:  Introduction to Mindmaps

Study Toolbox Part 1 - The Onion

This is the first post in a series called the Study Toolbox.  The aim of these is to share some hints & tips that I have found particularly useful in my QP training to date.

During one of my first meetings with my sponsor back in November he instilled the idea of an onion my approach to QP training.  Obviously this was not something I was expecting.  After confirming his alcohol consumption was within limits (it was a Friday afternoon..) we discussed it further and the analogy soon became clear and has stuck with me ever since.

It's all about the layering.  Onions are made up of multiple layers which become smaller and smaller as you head towards the centre.  This layering analogy lends itself well to preparing for the QP viva:

1. The outer layer:  This is the high level information you need to know about all aspects of the study guide even those dosage forms that you are not experienced in
2.  Subsequent layers:  Each subsequent layer represents additional detailed information on the specific area in question.  Each layer representing another level of detail.  The more knowledge you have the more layers are available to you.

The best way of showcasing this is via the use of mindmaps in the preparation of potential viva questions.  Stay tuned for a further post on this shortly....  

The Essential QP Study Guide

If after reading my previous posts you are still interested in QP training then the following document is well worth a read.  This contains all the information you will need to get you started.

The QP Study Guide


The study guide is published by the three joint professional bodies; The Royal Pharmaceutical Society, The Royal Chemistry Society & the Society of Biology.  The guide provides an overview of the Qualified Person within the pharmaceutical industry, summarises the practical experience requirements & roles of a QP.  The majority of the study guide contains all the topics required for QP application - aka the syllabus.

There are 3 foundation knowledge sections and 8 additional knowledge sections covering all aspects that a QP is expected to know for the viva.  You are expected to demonstrate a thorough understanding of the 3 foundation sections and an understanding of the additional knowledge sections.  The slight change in terminology reflects the wide range of roles/companies that trainee QPs are based.

The 3 foundation sections:

1. Law & Admin
2. Role of the QP
3. Quality Management Systems (QMS)

The 8 additional knowledge sections:

     4.  Maths & Stats
     5.  Medicinal Chemistry & Therapeutics
     6.  Pharmaceutical Formulation & Processing
     7.  Pharmaceutical Microbiology
     8.  Analysis & Testing
     9.  Pharmaceutical Packaging
    10.  Active Pharmaceutical Ingredients
    11.  Investigational Medicinal Products

On the face of it this looks relatively straightforward but once you delve into the study guide and look closely at each section there are comprehensive lists of topics to cover.  It is a common mistake to concentrate solely on the bullet points - you must also read the introductory paragraph for each subject as this provides a good overview of what the QP assessors are expecting from you. 

The Study guide was updated in February 2013 and is available from the professional bodies via their websites.  RPS & RSC require membership to download the latest guide.  The SoB still has the previous version from 2010 available on their website.  Although now out of date, the 2010 version still has the same 11 sections and will be able to give you an idea as to what  is expected.

Update:  The RSC website has all of the 2013 documents freely available here

The majority of the commerically available training courses will cover each section as a stand-alone training programme.  I'll cover the range of training providers on a future post