Friday's Round Up

Ben Venue Closure

Boehringer Ingelheim have finally decided to close their Ben Venue site in the USA following a number of quality problems.  Closure of facilities has been asked in QP vivas in the past and it is a good opportunity to consider your plan to manage this change.

Wockhardt Troubles continue

The MHRA have revoked their GMP certificate for another one of Wockhardt's manufacturing sites in India.   As a result the the facility will no longer be able to supply products to the UK.

Wockhardt Recall

Following the MHRA's action to revoke their GMP certificate a multi product recall was always on the cards. 

Recall following media fill fail

A recall of a sterile inhalation solution due to a media fill failure.  A good reminder to review your microbiology module and annex 1 for the requirements of media fills in sterile manufacturing and how you would handle a potential failure.

Actavis Bioequivalence problem

An interesting read regarding a failure of bioequivalence data for an existing product.

USP draft for non-sterile product bioburden

Bioburden is generally considered for sterile manufacturing.  Of note is the list of non sterile products in order of their potential risk of microbiological contamination:

• metered-dose and dry powder inhalants
• nasal sprays
• otics
• vaginal suppositories
• topicals
• rectal suppositories
• oral liquids (aqueous)
• liquid-filled capsules
• oral tablets and powder-filled capsules

Irish Rx charge increase 

The Irish government has announced  a 66% increase in prescription charges.  Will this increase the demand of patients seeking to find cheaper alternatives and hence lead to an increase in counterfeit risk in Ireland?

MHRA Q&A for MS holders

An interesting article for those who have little experience or appreciation of how aspects of the EU GMP guide is applied to MS (specials) manufacturers.

Friday's Round Up

Recall - glass particles

Hospira have recalled two injection products due to a defect in the primary container leading to a risk of glass particles within the solution.  There are a number of issues to think about here with regards to QP study.  Firstly was the AQL sampling of the primary containers at a suitable level?  What type of glass is used (type 1/2?)  A new component supplier?  Automated inspections for particles & ampoule integrity will not detect these types of defects.  This is also a good example of considering the extent of the defect as clearly the same primary containers are used for more than 1 product.  What would you response be to this - increased AQL sampling? For cause audit? Additional QC testing on container receipt?

Safety Reporting requirements of new CT Regulation

A good article highlight the proposed changes to the safety reporting requirements for investigators & sponsors.

Medical Device EU Safety Update

The EC has introduced two new safety measures for medical devices.  The new rules are focused on the notified bodies with regards to their auditing & assessment of manufacturers and clarifying the criteria these NBs need to meet.

FDA 483 for Indian API site

An interesting 483 report highlighting the deficiencies of an Indian API site.  For each audit observation it is good practice to talk through how you would take these findings forward if you were auditing this site as an API supplier of your finished product.

PV Black Triangle video

The EMA have published a patient-focused video describing the introduction of the black triangle system for medicines subjected to intensive PV monitoring. 

Update to EU-Japan MRA

The EMA has updated the MRA with Japan to permit the sharing of GMP data between manufacturers.  This means that the Japanese regulatory authority can accept reference to the EudraGMDP certificates.

Sterilisation & Disinfection Standards

A comprehensive list of all standards relating to sterilisation & disinfection.  A useful reference.

Doxil Drug Shortages

Yet more fall out from the ongoing issues surrounding J&J's Ben Venue facility in the USA.  A good reminder of the requirement for MAHs to inform the competent authority in all markets when drug shortages are expected.  Something to consider during your recall scenarios.

Hospira Recall - Particle contamination

A recall of a sterile injection due to a report of a dark particulate contaminant.  This has been identified as oxidized stainless steel.  What would be the likely source?  100% inspection performed manually or via automatic camera detector - one of the methods failed in this case.

Changing manufacturing facilities

Following the ongoing issues Ranbaxy is having with their existing sites in India the company is looking at purchasing a new site and transferring production.  This is a good example of a common scenario question of a change in supplier or site.  As a QP what would you need to see before manufacturing at the new site is started?  A change control would be a good starting point.....

EMA PV signals

The EMA have begun publishing PV signals reviewed by the PRAC. 

Malaria Vaccine

GSK look set to apply to the EMA for approval of their malarial vaccine during 2014.  It is not clear if this product is to be manufactured within GSK's new Ulverston site.



Happy Reading!

Friday's Round Up

The Buccal Route

I came across this paper this week and, although fairly old, it still provides a good overview of the buccal route for systemic drug absorption.  All relevant stuff for your formulation & medicinal chemistry modules.

Yet another FDA 483 for compounders

Following on from previous 483s for drug compounders, Speciality Compounding were inspected in March this year and this only came to my attention following their product recall last week.   The FDA are now taking some flak for the delay between the 483 and issuing the recall.  This 483 should be useful for solid dose trainees as an introduction to poor sterile manufacturing practice.

Patch in a Can

An interesting new development in transdermal drug delivery.

Biobetters Vs Biosimilars

Teva has announced new EU drug approvals for 'biobetters' which apparently improves on the original innovator product on which this new product is based.

South Africa MRA on the Horizon?

Legislative changes in South Africa may provide the potential for future MRAs with EU and FDA

Counterfeit seizure in Ukraine

A large counterfeiting operation has been uncovered in Ukraine.

EMA Paper on Nanotechnology coating

Novel Endotoxin testing

Something new to me this week following some revision of the standard endotoxin tests.  This test method is based on bacteriophage binding to LPS and removes the requirement for LAL. 

Revised PDA technical report

An updated revision of the PDA's technical report into dry heat sterilisation & depyrogenation methods.

P&G recall

Although for dog food these recalls can still provide useful scenario questions.  In this case, what is the potential sources of salmonella, clinical impact of salmonella, microbiology of salmonella etc



Happy reading!

Friday's Round Up

Wockhardt 483

Following on from my previous post regarding the multi product recall of Wockhardt products.  This informative warning letter really opens your eyes to the observed actions within the factory.  You have to ask where the QP oversight was and how these issues were not picked up during routine self inspection

GSK trial data issues

Yet more problems for GSK's China operations.  In addition to the well publicised bribery case issues have now been raised with clinical trial activity within China.  Namely the lack of pre-clinical data before products were given to human subjects.

Fresenius 483

Another revealing warning letter regarding an Indian manufacturing site.  The attempt at hiding documents by stuffing them into pockets is a particular highlight.  As with all these warning letters it is useful to get into the habit of using them as possible scenarios and how you would tackle them as a QP

TOC for Cleaning Validation

A useful 30min presentation/webinar on the benefits of using TOC for cleaning validation.  You'll need to submit details to access the presentation (there is no confirmation email so you can put any email in the box)

Top 20 Orphan Products

As mentioned previously orphan drugs are rarely out of the news.  Here is a great list showing the potential behind these lucrative drugs.

One for the Coffee Connoisseurs
Hence the reason copious amounts of coffee are available during DBA courses!


Happy Reading!

Friday's Round Up

API Importation Flow Chart

A good overview of the written confirmation requirements of API imports and a useful flowchart which outlines the process

CEP Update

The EDQM has updated the CEP certificate with regards to the listing of manufacturing sites.  From the 15th July the CEP certificate will carry details of all manufacturing sites involved in the manufacture of the API.  This includes sites performing packaging, micronisation, sterilisation & QC. 

Diovan Data Fabrication
Genentech Data Issues

Yet more reports of falsified data relating to drug development.  Repeated reports should be making you think of potential viva scenario questions relating to this and how you would tackle it.

Certificates of Medicinal Products

I came across the term CMPs for the first time this weeks.  CMPs are issued by the EMA to confirm the marketing authorisation status and the GMP status of the manufacturing site.   The appear to be primarily used for export to 3rd countries to support regulatory approval within that 3rd country.

Supplement Recall (FDA)

A recall for supplements containing medicinal active ingredient sildenafil.  A good example of how API supply chains are being compromised but will the FMD prevent this from happening in the UK?

Orphan Updates

Orphan drugs are rarely out of the news.  The EMA has updated its guidance on orphan applications and sponsorship transfer.  This document provides a good overview of the expectations of the EMA for orphan applications. 

Insects in vials (FDA 483)

More issues highlighted by the FDA relating to an Indian & New York CMO.  Insects within vials is certainly something I haven't come across before.  When you read about deficiency reports such as this it is good to get into the habit for thinking through your response if this was a potential QP scenario. 

FDA guidance on Technical Agreements

The FDA provide a good guideline on the requirements of TAs and scenarios where TAs have been deficient.

Lucentis & Avastin Equal in Efficacy

A study by the UK government to determine if these two treatments are equally effective for macular degeneration.  This is likely to further the debate between the NHS & pharma  where use of a drug off-label (Avastin) instead of the approval licensed product (Lucentis) has been justified on cost despite questions over the legality of this approach.

Happy reading!

GMP Principles in Principalities

Following on from my previous post on the entry of Croatia to the EU this post aims to give an overview of how the small principalities within Europe are integrated within the EU.  As a trainee QP you will need to know how the EU operates and importantly know sufficient information to enable you to provide answers to the round-the-world supply chain viva scenario questions.  These scenarios often involve complex virtual supply chains throughout and outside the EU. 

I'm sure many of you are aware of the EFTA & EEA countries but how would you handle a scenario question that included importing medicines from Monaco, San Marino or Andorra?  This post will aim provide you with the information required to answer that potential scenario.

Monaco 

Famous for its grand prix, casino and tax exiles, Monaco is a small principality on the Mediterranean coast bordered by France.  It is the most densely populated country in the world with a population of ~36,000 squeezed into a land area of 2sqKm.  

Monaco is not a member of the EU, EFTA or EEA and has no MRA in place with the EU.  Hence it can be considered, at face-value, to be a 3rd country with regards to medicine legislation.  However, since 2003 Monaco has a formal agreement with the EU regarding legislation for medicines for human & veterinary use as well as medical devices and cosmetics.   The formal agreement stipulates that certain EU legislation shall apply within the principality of Monaco and includes a number of familiar EU directives.  

EU directives relevant to QP that are incorporated into Monaco law:

• 2001/83/EC
• 2001/82/EC
• 2001/20/EC
• 2002/98/EC (blood directive)
• 91/356/EEC (previous GMP directive, 2003/94/EC not explicitly stated)
• 91/412/EEC (Vet GMP) 

These EU directives should be familiar to you all.  In general terms this means that Monaco complies with EU medicines legislation with regards to both commercial and clinical trial products as if they were a member of the EU.  Therefore the rules surrounding marketing, manufacture or importation of medicines will apply in Monaco as per other member states.  There are manufacturing companies within Monaco (Monegasque companies) that produce pharmaceuticals and cosmetics and some have valid GMP certificates listed on the EudraGMP database. Monaco also has a bilateral agreement with France that covers customs/importation legislation.  As a result when France adopt specific EU directives into national law Monaco will directly apply this French legislation into their own legislative framework.  

It is important to remember that these agreements with Monaco do not remove the requirement for auditing any relevant site within Monaco to determine compliance with EU GMP.  

Andorra & San Marino

 











Both the Principality of Andorra and the Republic of San Marino are 3^rd countries.  They are not part of the EEA or EFTA therefore access to the EU internal-market is limited.  They each have bilateral agreements in place with their immediate neighbours but they do not cover any EU medicine legislation.  The EU has produced a concept paper stating that inclusion of Andorra & San Marino to the EFTA and then EEA is a viable option that should be explored in order to better integrate both countries into the EU framework. 

Currently Andorra and San Marino does not have any mutual recognition with regards to pharmaceuticals.  As a result movement of pharmaceuticals between the EU and San Marino is restricted and importation requirements as for other 3^rd countries will apply.

Summary

Understanding the intricacies of the EU is a vital part of your law & admin module of the study guide.  Expanding your knowledge into very specific areas & countries such as Monaco should give you more confidence during your viva supply chain scenarios.  

Of the 3 countries mentioned only Monaco has implemented EU legislation regarding medicines and hence can be deemed as a 'quasi-EEA' member.  Both Andorra & San Marino have not implemented any relevant EU legislation and are therefore true 3rd countries.

Friday's Round Up

 
Counterfeit seizure by MHRA

The MHRA announced the seizure of over £12million worth of counterfeit medicines within the UK this week.  The types of medicines seized included weight loss, hair less and erectile dysfunction.  This operation also involved the closure of nearly 10,000 online pharmacies who were selling counterfeit or unlicensed medicines – will the EU-wide pharmacy symbol following FMD really stop these sites from emerging?


Class 2 recall for HES (MHRA)

All remaining stock of Hydroxyethyl Starch (HES) is being recalled due to results from clinical trials showing increased risk of patient mortality when HES is administered.  HES is given intravenously as a volume expander in critically ill patients following blood loss or trauma.   This is a good example of a recall initiated following ongoing PV rather than the more commonly observed quality defect.

Drug Manufacturing in Space

This interesting article describes how NASA has been investigating the potential for using 3D inkjet printing to manufacture drugs to sustain long space expeditions.  This technology has already shown promise with research from UCL & School of Pharmacy.   Will each space shuttle need an MIA and what legal jurisdiction is space……!!

Teva Packaging error

This error identified packs of furosemide containing zopiclone that was packaged within Teva’s site near Paris.  The article describes the investigation into this and a potential root cause of sabotage.   What would your thoughts be as a QP if you uncovered or suspected this activity within your organisation?

2nd hand medicines?

This article describes a scheme within California that collects unwanted medicines from care homes and re-distributes them to clinics in order to provide assistance to those patients who cannot afford the cost of healthcare in the States.  As a QP do you know the fate of your medicines within the UK?  What happens to patient’s medicines that are returned to pharmacies or hospitals?  

Fraudulent activity at Ranbaxy  

This comes on the back of 2 other reports of companies generating fraudulent data in both USA and Scotland.  Could this be a potential QP viva question?  How would you as a QP tackle this issue if brought to your attention?

Happy Reading!

Study Toolbox Part 5: Visits

This post will provide a guide to getting the most out of your visits and hosting reciprocal visits of fellow QP trainees.  Visits will form a significant part of your QP training.  For most of us our working environment will not cover all the dosage forms and relevant aspects within the study guide.  Even those trainees working for large multinational companies there will likely be areas of the study guide that they wont be able to cover within their respective company.  This is especially important for those trainees within specialist areas such as PET radiopharmaceuticals, ATMP & medicinal gases.

Tips for arranging visits:

1.  Gap analysis

A gap analysis of your current CV or draft application form against the study guide will identify areas that you are not familiar with.  Listing these will form the basis of the ideal visits that you'd like to arrange to plug these gaps.  Your sponsor should be heavily involved in this process to ensure that all areas are considered.

Coming from a NHS background I identified a number of areas I'd want to visit.  These included, water systems, high speed packaging lines, API manufacturer (biological & chemical), high speed sterile filling lines as well as RA & PV departments.

2.  Networking

Once you have identified the main areas that you'd like to cover you'll need a list of appropriate contacts of people who may be able to arrange a visit.  This is where your sponsor should be able to help.  They should have a great network of contacts that you can utilise. By now you may now have built up your own network from training courses, conferences, symposiums etc, so now is the time to dig out those business cards and start emailing.

3.  Arranging a visit

One of the most important aspects of visits is knowing what you want to get out of them before you go.  Your aims should be discussed with your sponsor and your host in order to determine how long you will need to meet these.  Once you set a date for the visit begin working on an itinerary with your host.  Sometimes your host will provide an itinerary but you will need to ensure everything that you want to cover is included - if it isn't then amend the itinerary.  If necessary be specific and focus on one main topic for your visit especially if your time on site is limited.  During one visit I focused solely on the facility's water system and nothing else as I only had a half day on site.

It is always worth asking for a scenario session with the host which covers typical examples (real life if possible) that occur within their processes. 

4.  Preparing for the visit

Leading up to your visit it is important to spend some time preparing for the things you'll likely be witnessing.  try to get as much background knowledge on the subject area before you go.  Your sponsor should be able to provide you with a good overview of the subject but there are some good alternative sources available to you. Before heading to visit a high speed packaging line I searched you tube for the packaging line manufacturer (Ulhmann) and found a number of useful videos which gave me an idea of what to expect.

5.  During the Visit

Don't turn up empty handed - always bring some biscuits, sweets etc for the host and their team.  The other important thing to bring with you is a memory stick/usb drive.  Most of the trainee QPs will have numerous electronic resources which they may be willing to share.  It helps if you bring some of your own to trade!

Its important to ask as many questions as possible especially if there is a certain process or piece of equipment that is of interest to you.  I found it useful to put your auditor hat on during visits as this will help you to identify areas of risk and can lead to discussions over critical control parameters and in-process tests.  With my visit to the high speed packaging line it was useful to relate that process to the manual packaging process I was used to.  Ultimately the same controls are in place - the only significant difference was the volume and automation used in high speed lines. 

'If you don't ask, you don't get'.  If there is something you'd like to see, whether that is a SOP, deviation report etc then ask!  I was lucky enough on one visit to be able to view a complete marketing authorisation.  As my main experience has been with IMPs I had never seen a MA before and hence this was an obvious gap in my knowledge!  This was asked for in advance by me and meant that this was scheduled into the itinerary.  As a result I had the privilege to be talked through the MA contents by the company's PVQP.

6.  Visit end

Ensure you get all the contact details from both the trainee QPs and qualified QPs on site.  This will help build your network and if the trainee QP is a similar way through their training then it could be an opportunity to arrange regular telephone sessions.  Always  offer a reciprocal visit for their trainees to visit your own site. 
Once back at base you should update your application form with what you have gained from the visit.

7.  The reciprocal Visit

Arrange a reciprocal visit follows the same steps outlined above.  Even though you may think you wont have much to offer someone from 'big pharma' remember that those trainee may have only ever experienced high volume pharmaceutical manufacturing.  I have hosted a few visits of commercial pharma trainees and I think they gained something by reviewing small scale IMP manufacture and specialist equipment such as laminar cabinets & isolators. 

Hosting visits is a really good way of validating your own knowledge in your systems & processes.  It is almost like being audited especially if the visiting trainee QP is bombarding you with questions!  Make the most of this as one of these questions may crop up during your viva.  Again, include some scenario questions, real-life deviations and how they were dealt with during the visit.  It is a good opportunity to see how someone other than your sponsor tackles specific problems. 

Summary

Visits are an important part of your QP training.  You should aim to make the most of your time on site with arranging itineraries before hand and identifying the main objectives of your visit.  Witnessing first hand enables you to visualise processes, equipment and their associated noise, smell and scale - far better than any book or lecture could. 

I have been very fortunate to have been on a number of visits to commercial pharmaceutical companies.  Personally I think coming from the NHS helps for once as we are not a commcercial competitor and the NHS for many companies is a large customer and therefore are often willing to give something back.  I have to thank the following companies for hosting me (and feeding me!); Teva, Rosemont, Eisai, Guy's Hospital, Amdipharm/Mercury Pharma & Wockhardt. 

If anyone would like to visit my facility please feel free to contact me via this blog or my Linked In profile.


Study Toolbox Part 1:  The Onion
Study Toolbox Part 2:  Introduction to Mindmaps 
Study Toolbox Part 3:  Keeping up to date 
Study Toolbox Part 4:  Training Courses

The Application Form

One of the most important pieces of the QP training jigsaw is the QP application form.  This and the Sponsor's form provide the professional body with documented evidence of the candidate's experience and is the first part of the assessment process.  The aim of the application form is to show the assessors that you have covered all the relevant knowledge & experience you need to act as a QP.  The assessors will compare your application form to the study guide to ensure all the requirements have been met.


The QP application form is analogous to a job application.  The application form is used to show you have the required skills and experience for the job and is primarily used to get you an interview.  The QP application should be treated in the same way - it is your ticket to being called for the viva.  Therefore it should be thoroughly checked for omissions and errors before submitting.  Your sponsor will play an important role here as they will need to countersign your application form.   Guidance for completing the application form for both applicants & sponsors can be found here and is definitely worth a read before making a start on your form. 

Tips for completing your QP application form 

     1.  Start early

Ideally you should start competing your application form as soon as possible.  Large sections of the application form cover personal details & employment history.  Most of these data can be lifted straight from your CV.  Even something as simple as this can take a lot of time so be prepared and plan your time effectively.  You can then build your application form over time as you gain experience from work, visits or training courses.

My sponsor left his application form till the end of his training thinking it would not take long to complete.  In the end it took him over 2 months to finish the application form!  At this stage of your training you want to be spending all your effort on revising not completing your application form     

     2.  GAP analysis

When populating your application form have the latest version of the study guide open.  Perform a gap analysis of your current application form content verses the content required by the study guide.  Your sponsor should be willing and able to do this for you.  Once you know the areas that require further work you can tailor your training program to meet these objectives.
 

After my initial gap analysis I typed out all the missing sections in red.  Once each section was completed I simply changed the font to black and moved on to the next section.  Using a different colour font helped me to prioritise those sections of the study guide.


     3.  Be specific

After a while you can lose the will to live whilst completing the endless sections of the application form.  It therefore becomes easy to write generic statements in an attempt to rush the process.  The assessors reading your application form will be looking for details of what you actually did.

For example: which statement would best demonstrate to the assessor your knowledge on supplier audits? 
 - Perform supplier audits
 - Performing a supplier audit on a media manufacturer who supplies my organisation.  The audit included a  review of the supplier's ISO9001 certified QMS, media manufacturing processes & facilities.

     4.  Know your dosage form

The contents of your application form will dictate some of the lines of questioning from the assessors.  This will be particularly important when it comes to your specified dosage form.  You obviously wont be expected to know every dosage form but you'd better know all the ones you put down on your form - especially those other dosage forms on your MIA license. 

Summary

The application form is a critical part of your application process and will provide the assessor's a first impression of you and your potential to be a QP.  Completing the form takes time and I would highly recommend starting as soon as possible.

Thanks to my sponsor for help with this article and for reviewing my own application form!

Study Toolbox Part 4: Training Courses

This 4th post in the Study Toolbox series will provide an overview of the training courses available to help you on your long road to eligibility. 

One of my previous posts gave a brief overview of the QP Study Guide which provides a general syllabus that all prospective QPs are expected to have a detailed understanding of.  There is a wealth of topics within the Study Guide and the breadth of topics can be overwhelming at first glance.  This may be of particular relevance for trainee QPs from either small scale manufacturing operations (like me) or from those from relatively niche areas such as  PET radiopharmaceutical or medical gas manufacture.

So how can you demonstrate you have the required knowledge & experience in all 11 sections of the Study Guide?   The training providers listed below will provide this but they are not compulsory or expected to be on your application form.

Commercial Training Providers

Training courses are one way of gaining sufficient knowledge.  The main commercial training providers offer modules based on each of the 11 sections of the Study Guide.  These courses not only provide comprehensive training but also provide a fantastic opportunity for networking with other trainee QPs.  This is especially important for identifying potential study partners and arranging reciprocal visits.  (I'll aim to cover visits in a future post).

NSF-DBA

The David Begg Associates courses have been running for a number of years now and are viewed by many to be the gold standard with regards to QP training packages.  The full course is linked with the University of Strathclyde and offers candidates the opportunity to gain a post graduate certificate, diploma or MSc.  The modules run over 21 months but you can pick and choose the modules to fit in with your own requirements or knowledge gaps.

Each module lasts between 4 to 5 days in Durham or York Marriott hotel conference centres.  Lecture notes for each module are substantial and include not only the slides but a very useful overview of each lecture in an easy to read format that compliments the slides really well.  The week long course is broken up into lectures and practical group work.  Written exams are held for those students aiming to complete the post graduate university course.

Is there a downside?   At circa. £3-4k per module the cost my be prohibitive for some companies or individuals who are self-funding (like me).  Also the length of the course means added expense of hotel & travel.  DBA offer special rates for the Marriott hotel at circa. £100 per night and will obviously provide a great platform to continue the networking into the early hours!   

DBA does offer a generous 50% discount for NHS employees which then brings it the price down in line with other providers.  To qualify for the discount you'll need a confirmation letter from your employer and DBA will then invoice you with the discount included.

DBA also offer a free annual QP training day for prospective students and their sponsors.  The date for this year is May 14th and I'll be heading up for the day.  It might be worth contacting DBA directly to enquire for last minute availability.

RSSL

RSSL specialise in scientific analysis, consultancy, product development and training for the pharmaceutical and food sectors.  Their popular QP training packages offer the similar layout to DBA by offering 11 stand alone modules the reflect the Study Guide.  There is no university collaboration so post graduate qualifications are not available to run in parallel with the QP course.

RSSL has its advantages over DBA.  The training is held within Reading and typically over 2 days meaning less impact to your work and family duties and may not require nights away from home for those based around London.   The costs per module is more accessible at circa £1.5k.  The shorter duration of the module means more of a focus on the relevant details required for your QP training.  The notes are more succinct than DBA but do not provide the excellent text overview for each lecture.   

Inspired Pharma

Inspired Pharma offer an alternative platform with their QP training.  They provide online tutor-facilitated courses on the Study Guide topics.  This allows you to fit the training in and around your busy work/life schedule without the need to spend 3-5 days on a residential course.  There is not a great deal of information on their website regarding the costs of these courses but I would suggest emailing them for further information.

Pharmaceutical Quality Group

Although not strictly a QP training provider, the PQG is an invaluable source of information for trainee QPs.  Membership is only £17 per year and this provides access to a wealth of documents and presentations available via their website.  For trainee QPs the PQG provide QP seminars specifically aimed at trainees and newly qualified QPs.  These full day seminars based in London provide a great introduction to QP training.  They cover the application process, requirements and legislation/GMP update session.  

My first foray into the QP training arena was attending last year's November seminar.  I found it extremely useful and a great opportunity for networking with other trainee QPs from the pharmaceutical industry.  I met a great study partner from this course and we still have weekly calls to discuss scenarios etc. 

The PQG also arrange visits to a wide range of pharmaceutical manufacturing facilities, distributors, API manufacturers.  The events page on their website gives all the visits coming up.  These are particularly good value at around £60 per visit. 

Non-Commercial Training Providers

Q3P (UCL School of Pharmacy)
 
This is the only non-commercial provider that I am aware of.  The Q3P course was initially aimed at addressing the shortage of QPs within the NHS sector.  The course is free for NHS staff and provides a similar layout to the commercial providers in following the Study Guide with 1 or 2 day modules.  Although still in its infancy the course is now enrolling its 3rd cohort.  The training has evolved since the first cohort and includes lecturers from both the pharmaceutical industry and NHS sectors as well as QP assessors. 

The Q3P course has a free open day on the 6th June 2013 for prospective students.  See their website for details.

Post Graduate University Courses

There are a number of university courses that cover some aspects of the Study Guide.  Although not specifically tailored to QP training they do offer a good grounding in the essential elements of pharmaceutical manufacturing & quality assurance.  These part time courses are designed on a modular basis and will provide the opportunity for post graduate qualifications to MSc level.  Post graduate qualifications are available with the NSF-DBA course (see above).

PIAT (Manchester University)
Industrial Pharmaceutical Sciences (Brighton University)
Pharmaceutical Technology (Bradford University)
PTQA (Leeds University)
Leeds University has now stopped supporting the PTQA course and currently there is no further information on the future of the course.

Completion of these courses would usually be expected before gaining QP trainee positions.  From there the QP trainee would often be sent on the specific commercial training courses to build on the knowledge from the post graduate course. 


Individualised Mentoring & Training

All of the courses above will provide you with a great amount of knowledge covering all aspects of the Study Guide.  However it must be noted that attendance to these course wont automatically get you through the viva.  The knowledge gained wont provide you with the detail and expertise required to structure well reasoned responses to the viva questions. 

This is where personalised training will help translate your knowledge into a well structured format to get you through the viva.  They will also offer to review your application form and provide either face-to-face or telephone training sessions tailored to suit you and your specific requirements.  The providers will also be well networked within the QP community and hence should be able to provide contacts for potential visits.

QPQuandary

This personalised training company provides coaching and mentoring to both QP trainees and sponsors.  It is run by Alex Hall who provides teaching on some of the commercial training courses including RSSL & Q3P as well as one-to-one coaching.

Alex is the RSC Chief Assessor and senior QP for Roche, but will be running QPQuandary full time in the near future. Therefore she knows what it takes to get through the viva and can provide mock vivas, application form reviews and numerous other services to help meet your training needs. In addition she provides a fantastic weekly teleconference service for groups of QP trainees from a wide range of backgrounds. For more information see the QPQuandary website for her contact details.


Other Training Sources

Self Study

Your own personal study underpins everything you learn both from your job and attendance at training courses.  There are no shortcuts.  You will have to hit the books for hour after hour to ensure all the knowledge remains at the forefront of your mind especially leading up to viva day.  Self study is acceptable for inclusion into your application form.

In House Training

Some of the larger companies (e.g. GSK) provide substantial in-house training programmes for trainee QPs that rival even the DBA course.  For those with shallower pockets in house training can be provided by your sponsor or from subject matter experts within your company.  This can be on a one-to-one basis or as part of departmental-wide training sessions. 

My own training plan

My training is underpinned by a Pharmacy degree and  post graduate diploma in the PTQA course.  I've chosen a pick n' mix selection from the training providers in order to fill in the gaps.  A gap analysis really helps identify those areas that need supplementing with training courses.  I'll be using DBA for API manufacture, roles of QP and Law & Administration courses this year.  Law & Admin and QP roles are essential as they form the majority of the fundamental modules of the Study Guide.  API manufacture is not something I have exposure to from either work experience or from my previous training courses and hence is a significant knowledge gap for me.  In addition to these I've booked a mock viva & mentoring sessions with QPQuandary as a milestone for me prior to submitting.  I've also got into the habit of self study most evenings to supplement all the above.

 Summary

There are a wide range of QP training courses available to cater for all your training requirements.  They are not compulsory for getting to the viva but will provide you with the knowledge, networking and confidence in new subject areas.   Supplementing these with one-to-one coaching sessions either from your sponsor or specialist training providers should provide the final polish for you before you enter the lions den.

I'm sure there are other providers out there.  Please add any to the comments section below.


Study Toolbox Part 1:  The Onion
Study Toolbox Part 2:  Introduction to Mindmaps 
Study Toolbox Part 3:  Keeping up to date

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

Which licenses qualify for the pracitical experience?

As this post explained, the requirement to become eligible to be named as a QP is dependant on a number of conditions.  One of which is the 'practical experience' of 2 years within an authorised manufacturer of medicinal products. 

What does 'authorised manufacturer' actually mean?

Within the UK the following manufacturing licenses qualify for 'authorised manufacturer':

• MIA
• MIA(IMP)
• ManA (veterinary products)

Other manufacturing licenses covering specials or unlicensed medicines such as MS, MeAT licences do not qualifiy.  Licences for wholesale dealing such as WL, WDL & WDA do not qualify either.

For those aspiring QPs from the NHS sector (like myself) you will need to have a MIA(IMP) license - the specials license that many NHS hospitals hold will not enable you to apply for QP eligibility.

Interestingly, there is no requirement for the license to be active within the 'practical experience' requirements of 2001/83/EC.  Therefore within your 2 year experience you may not actually witness a single batch being certified!  However, I would certainly not recommend this.  If your license is relatively inactive then you need to be going to industrial visits to shadow QPs during batch disposition.  I'll aim to cover a separate post on arranging industry visits as part of your QP training.