The Viva - Pt 1

After finally completing my QP journey I thought I would write a couple of posts to describe the final few steps leading up to the viva.  This first post will concentrate on completion & submission of your forms and the final preparation leading up to the big day.  The subsequent post will review the big day itself.

I've previously posted about the application form and by now this should all be complete and checked by your sponsor to ensure all aspects of the study guide have been met.  Your sponsor will also need to complete the sponsor form before you can submit.  This is an extensive form that will require your sponsor to document your suitability for QP eligibility.  Completion of this form is not a 5 minute job so don't leave this to the last minute!  The form was updated last year and requires significant input from your sponsor on your progress with detailed examples of how you have met certain aspects of the guide.

Someone once said 'the waiting is the hardest thing' and once you have submitted all your forms there is not much more you can do but wait.  The first contact from your professional body's QP officer will be confirmation of receipt of your application and fee.  Assuming there is no administrative errors with your application form the next contact from the QP officer will likely be a month away whilst your application form is reviewed by 2 QP assessors.  Occasionally the QP officer will contact you on behalf of the assessors for further information or clarification of specific areas of your application.  Once the assessors are satisfied with your application the QP officer will contact you to arrange a date for your viva.  This date maybe anywhere from a few weeks away to over 6 months away - it all depends on the numbers of trainees and cancellations.  Following a verbal confirmation of the viva date you will be sent details by post which you will need to confirm in writing that you are going to attend.

My Experience

My application forms were submitted early December 2013.  Within a week my QP officer emailed me to request clarification regarding my sponsor's details.  The next correspondence was a call from my QP officer in mid January 2014.  This was to invite me to an assessment interview.  At this point I was informed of a cancellation and a vacant slot for the first week of March.   The next available dates were not until May/June so I decided to accept the offer of the earlier viva.  I received confirmation of the date, time & location in the post a few days later.  It was somewhat of a relief to finally have a date to work towards.

Final preparation


During the weeks leading up to my viva I continued to study but the focus changed from knowledge gathering to polishing my strategy for dealing with scenarios and answers to questions that were likely to come up.  I worked closely with my sponsor at this point to test run specific answers to questions such as supply chain, legal/routine duties, tech transfer, water systems, cleaning validation & method validation.  I also revisited the processes for my products to ensure I knew all the relevant critical control points.  This also enabled me to start predicting scenarios relating to my processes and how I would tackle them if they arose during the viva.  With only a week or so remaining I started to reduce my studying time as I was worried about burning out from all the work I had been putting in over the previous few months.  I was happy that my knowledge and scenario strategy was ingrained within me so I saw no real need to try and cram more and more revision in.  This decision was somewhat made for me as I had to prepare and host an MHRA inspection the week before and attend my friend’s stag weekend in Wales the weekend before – probably not the best preparation but it was nice to be able to switch off for a few days.

And then my viva date was finally here……

Friday's Round Up

With Viva day fast approaching posts have been few and far between lately.  Here is a quick round up of the latest news & updates.


Preparing for Serialisation in the USA

The USA's answer to the FMD is pressing ahead with package serialisation or track & trace systems which are due to be implemented by Jan next year.  Lets hope there is at least some degree of harmonisation between the USA and EU once the EU finally agree on their 'safety features'

Merck recall

A recall due to potential fault with the primary packaging which may affect the stability and/or efficacy of the drug.  A good reminder for your packaging revision, specially control over packaging components, receipt & inprocess testing on blisters.  As ever with recall scenarios always consider the extent of the problem - any other products affected??

China - 'not worth the hassle'

so says Actavis after announcing a withdraw of their operations in China.

India to allign with WHO GMP

Following all the recent scandals involving GMP failures in Indian plants the Indian government has decided to revise their GMP guidelines to allign with the WHO GMP guidelines. 

Contents of the CTD (US version)

A simple overview of the contents required for each module of the CTD.  This is from the FDA site so bear in mind that Module 1 will be slightly different from the EU CTD (no QP declarations for a start!).

PIC/s Update to GMP

PIC/s have published their latest GMP guide which comes into force from March 2014 and now includes sections on QRM and ICH Q7 requirements.  PIC/s have also updated their guidelines on the preparation of medicinal products in healthcare settings. 

Ranbaxy Woes

The FDA issued an import ban on one of the Ranbaxy sites in India following serious GMP deficiencies uncovered during an inspection.  It will be interesting to see how the EU regulators act on this information.  Remember the Wockhardt recall a few months back....................

Immukin Recall - UK

Another manufacture led recall that may have flown under your radar.  This recall was caused by an unknown impurity uncovered within ongoing stability studies.  Viva scenarios based on failed stability testing are fairly common.   Remember to confirm the result with an OOS investigation before heading straight into your investigation and recall!

Coring of bungs

The use of needles in small scale aseptic units is common and these pictures show you the importance of no re-using needles.  The blunt needle is more likely to core the bung and introduce particulate contamination into the product.  A good training aid nurses during reconstitution and administration of medicines.

QP Networking Event

@qpquandary is organising a QP networking event for March/April this year in London.  This should be a good chance to meet fellow trainees and QPs to broaden your network.  I'm sure the networking opportunities will continue in the pub afterwards - first round on Alex?

Happy Reading!

Friday's Round Up

Happy New Year!

Class 2 Recall

Teva UK have recalled a batch of methotrexate injection due to reports of damaged vials.  Methotrexate is a good example of a product with multiple indications and possible routes of administration - something you need to consider in your risk assessments

Webcast on metal contamination

Pharmaceutical Technology journal is sponsoring a free webcast on January 22nd covering the methods used to prevent metal contamination within pharmaceutical products.

EMA guidance on IVRS

The EMA has recently published a guidance document on the use of IVRS and their justification for the removal of expiry dates from IMPs.

QP Good Practice Guide

The ECA & QP Association has published a QP good practice guide.  There is an interesting  Q&A session and the end.

Airing your dirty linen

The EudraGMDP website now publishes non-compliance reports for all those naughty sites audited by competent authorities.  Each report gives a good overview of the products affected and a brief overview of the nature of the non-conformance.  A good resource for scenario questions!

PLPI company led recall

A labelling error has led to the recall of a batch of crestor from a PLPI company.  A good reminder of the requirements for PLPI products and the activities they perform.  These tend to be generally smaller scale, manual operations compared to large scale pharma.  I wonder if Astra Zeneca (the reference MA holder) received complaints regarding this affected batch?

Baxter recall - Clinimix

Baxter have recalled a number of batches of clinimax parenteral nutrition products due to particulate contamination.  Part of their risk reduction strategy recommends visible inspection for particles prior to administration and to administer products via an in-line filter incorporated into a giving set. 

Over regulation of Opioids

An interesting article looking at the flip side of regulating the supply of opioids leading to patients going without critical pain relief medications.  This is a good example of the 'local laws' referred to in 2001/83/EC as controlled drug legislation is complex and variable throughout the EU and ROW.

Used Equipment

All you'll ever need to get started in the murky world of counterfeit manufacture.  Do these auction sites perform checks on the bidders?

Drug Donation Programs

An article describing Janssen's donation program for supplying HIV medication in Africa.  My initial thoughts hark back to the issues with 'diverted stock' from a number of years ago and whether this may be repeated. 

Class 4 Drug Alert

Teva has issued a drug alert due to an error in the dose stated within the PIL.

Tamiflu in the News

An interesting discussion on the transparency of clinical trial data with a focus on Roche's product Tamiflu. 


Happy Reading!

Study Toolbox Part 7: Mock Vivas

QP eligibility is largely determined by your performance during an oral assessment by members of the joint professional bodies.  You may have ticked all the boxes for the application process; submitted a fantastic application form; gained years of experience as a quality professional and been highly praised within your sponsor's form but without performing on the day of the assessment all this may go to waste.  With so much riding on the outcome of the assessment it is worth spending time to understand the assessment process and have a few practice sessions beforehand.  You wouldn't sit your driving test without first practicing out on the roads would you?

The Viva Process

QP viva assessments typically last between 60 and 90 minutes.  Within that time the assessors will need to assess your ability to meet the aspects of the study guide and to test your application of knowledge into real life scenarios.  Questions often consist of knowledge based, factual questions and scenarios where you play the part of a QP. 

The vivas are held at one of the headquarters of the 3 professional bodies in London and your friendly QP officer will be there to great you before you go in.  The panel consists of 3 assessors, one from each professional body with your own professional representative acting as the chair.  Your QP officer will be present to take notes during the assessment.  Occasionally trainee assessors and observers from the MHRA may be present but these personnel have no bearing on the outcome of your assessment.  Once the assessment has finished you are invited to step outside of the room whilst the assessors discuss your performance.  Usually within 5 to 10 minutes you are called back in to be told if you have been successful. 

Therefore the viva will subject you to a grilling by strangers in an unfamiliar environment, far removed from the comfort of your office.  In order to fully prepare for the viva it is important to try and replicate this as much as you can.

When should you begin mock vivas?

The short answer is; when you are ready.  There is little to gain jumping straight into mock vivas early on in your QP journey as you run the risk of becoming despondent and your confidence may take a hit.  I believe it is better to have gained the majority of your knowledge & experience; completed your visits and completed your training courses before attempting formal mock vivas. 

Informal Mock Vivas

The knowledge based questions are the easiest to practice as these require very little preparation by the 'assessor'.  As a result it is probably easiest to start off with these questions in order for you to practice saying answers out loud - something we are not always comfortable with.  Informal vivas can be performed with either your sponsor, colleagues or study partners especially if they are at a similar stage in their training.  These informal vivas can be performed at any convenient time during the day and will provide a good test of your knowledge base. 

Once you have performed a few of these informal vivas you should begin to develop your own strategy in your structured answers to common questions on legal/routine duties, legislative updates & QMS components.  Although informal you should always try and get some feedback from your performance.  It is important to know your strengths and areas for improvement so you need your sponsor/colleague etc to be honest and constructive in their criticism.

Formal Mock Vivas

Once you have experienced a few informal vivas you should begin arranging more formal mock vivas.  The aim of these is to try and recreate the real thing as far as possible.  This will often require a significant amount of preparation, usually by your sponsor.  Ideally you should clear at least 2 hours from your hectic schedules and book a room away from your office where you will not be disturbed, preferably in a room unfamiliar to you.  Your sponsor will also need to find time to prepare the questions and scenarios well in advance of the mock and invite at least one other person along to recreate a panel of assessors.

You should try and treat these formal mock vivas as if you were doing the real thing.  Your answers should be well structured and you should be acting as if you are already QP and to test run your strategy for answering scenario questions (eg using the PIPER mnemonic).  This is also a good opportunity to see how you react to potential mistakes you make in your answers to see if you can move on and focus on the next question.  Again, getting feedback from your 'assessors' is vital, even if what they say is not what you want to hear.  Hopefully you can take away those areas where you need more work and prepare better for the next one. 

Having your sponsor present during these mock vivas is important as they will be the only person who will be able to track your performance from your first few informal vivas all the way to formalised vivas.  It is good to ask your sponsor to play the part of an observer as you'll be fairly used to their line of questioning by this point.  Personally I liked having my sponsor present in all my mock vivas as I trusted his review of my performance without question and I wanted to impress him to show that I have been putting the work in!

By this point both you & your sponsor should be in a good position to assess your readiness for submission.  For me my final test was to arrange a formal mock viva with one of the dragon's themselves.  It is worth remembering that usually your sponsor and any other QPs giving mock vivas only have experience of 1 real viva (unless your sponsor is an assessor, or they took more than 1 attempt...) whereas an assessor has had the 'pleasure' of sitting through numerous vivas and will provide a definitive review of your performance.  My formal mock was with Alex (@QPQuandary) who provided me with a recreation of an actual viva, including all the preamble regarding the purpose of the assessment and potential confidentiality issues.  My sponsor and I had decided that if this mock viva went well then I would submit my application form so it gave me something to work for.

Learning Points:

• You are allowed to say 'I don't know' as long as you can tell the assessor where you would look to find the answer
• You can move the line of questioning to cover products you are more familiar with
• Listen to and answer the question, not the question you thought (or wished) you had heard
• If you remember an answer to an earlier question that previously alluded you mention at a later stage in the viva
• Mock vivas are tiring, especially if they are examining all areas of the study guide.  Short breaks will be needed if the mocks last more than 2 hrs.
• Learn from your mistakes and take constructive criticism positively!
• vary your 'assessors', don't rely solely on your sponsor so dig out those business cards from your networking sessions
• Play the part of the assessor for a few informal vivas as this will give you a different perspective to the viva process.

Summary

Mock vivas are a great tool to help with your preparation for the real thing.  They can provide a good insight into your readiness for submitting as long as you are ready to go through the process.  Having a mixture of formal and informal mock vivas should ensure a thorough test of your knowledge, provide you with ample opportunities to polish your answers to common viva questions and take your scenario strategy for numerous test runs.  Good Luck!

Think interview not firing squad!

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
Study Toolbox Part 5:  Visits
Study Toolbox Part 6:  Teleconferences

Friday's Round Up

Class 4 Drug Alert - Fentanyl Patches

Takeda have issued a class 4 drug alert for one of their fentanyl transdermal patch preparations due to incorrect packaging details.  The details of the drug alert would suggest that this may be escalated to a recall once corrected stock is available.

Class 2 Drug Alert - Tixylix Oral Liquids

Novartis are recalling a number of batches of their Tixylix cough preparations due to a manufacturing fault with the primary container.  This echoes the Boots manufacturer's led recall from last week.   Why one was deemed a class 2 recall and the other a manufacturer's led recall  is unclear to me....

More UK Investment from GSK

More good news for the UK's pharmaceutical manufacturing industry as GSK has announced further investment into their Ware and Worthing sites.  Will they need more QPs??

New Local Laws in UK

Following the introduction of new drug driving laws to be implemented shortly, the MHRA has issued a statement requiring MA holders of specific drugs to update their packaging components with new warnings for drug driving.  A good example of how QPs need to be aware of updates to local laws - not just GMP updates.....

Deficiencies at API manufacturers

An article detailing the inspector training and common deficiencies identified by PIC/s during inspections of API manufacturers.

QbD for Sterile Manufacturing

QbD has been well described in the non sterile solid dosage form arena over the past few years.  This article describes the challenges of implementing QbD in sterile manufacturing processes.

Horizon 2020 Launched

The EC's funding stream was launched this week and follows on from the framework funding programmes (FP7).  The EC has made 71 billion Euros available for grants over a 7 year period for a range of scientific disciplines including healthcare. 


Happy Reading!

Friday's Round Up

Locals Laws & the QP

Industry responses to the draft annex 16 suggest that the requirement for QPs to know all the local laws in all markets is unrealistic.  That maybe so but the QP legal duties defined in 2001/83/EC are pretty clear....

Drug Alert - Sodium Bicarbonate

BBraun has issued a class 4 drug alert for a number of batches of sodium bicarbonate due to the presence of precipitation within retained samples.  This appears to be caused by defect in the rubber stoppers.  A great example of how changes to primary containers/closures can have a significant effect on product quality that may not manifest itself for a number of years (batch was distributed March 2012).  Another interesting point is the statement explaining that a recall is not an option at this time due to the potential of product shortage within the market.  It will be interesting to see if these batches will be recalled at a later date once additional supply has been introduced into the market.

Rapid Drug Quality testing

An article describing an innovative technology that can be used to test for active ingredient concentrations within finished products.  This technology is being targeted for use by clinicians to help in the fight against counterfeit medicines.

ICH steering committee

Details from November's ICH steering committee. 

EMA offers greater orphan incentives

Orphan drugs are rarely out of the news but despite the huge increase in orphan development and huge returns for those companies developing them, the EMA is applying even more incentives for orphan drugs.

Drug shortages causing patient harm

An interesting article describing how drug shortages within the UK is having a direct effect on patient health.  Something to ponder during your viva scenarios when deciding whether to recall or not.


Micro OOS webinar

A free on-demand webinar (once your details are submitted) on managing out of specification investigations originating from the micro lab. 



Happy Reading!

Friday's Round Up

GSK continues with UK manufacturing investment

News that GSK is ploughing further investment into its UK manufacturing arms.  After recent investments into their Ulverston site there is a further £23million for expansion of their Montrose facility in Scotland.  Great to see GSK bucking the trend of outsourcing UK manufacturing.

Boot's Pharmaceuticals recall - Oral liquids

A company led recall issued by Boot's via the MHRA website.  Remember these recalls are considered low risk and hence are not disseminated via the Drug Alert system.  The recall is due to potential faulty tamper seals on a range of their liquid formulations.

New Drug Target for Malaria

Novartis has published data on a novel drug target and new class of antimalarial compounds in the journal Nature.  

Baxter recalls Nitroglycerin Injection

Another recall due to potential particulate contamination within a sterile product.  A good reminder to revise the tests used for both visible and subvisible particles in finished products. 

US Congress gives more power to FDA over compounders

Following the fallout from the NECC compounding disaster from 2012, Congress has finally reached an agreement to update the legislative framework overseeing this high risk activity.  The revised bill gives the FDA more power and establishes a voluntary program for compounders to register with the FDA and agree to meet relevant quality standards.

API catalysis

An interesting article describing the advances in the use of catalysts in both chemical and biological API production.  A good prompt to revise the recently published draft ICH guidelines on elemental impurities.

FDA/EMA QbD Q&As

The FDA and EMA have published an update to their joint guidance document on quality by design.

Comments on Annex 16 published

The EC yesterday published comments on the proposed update to Annex 16.

Update to GDP Guidelines

A new version of the GDP guidelines has been published to correct some factual errors and give a formal date of coming into operation (24th November 2013)



 Happy Reading!