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!

Friday's Round Up

Overkill Overview

A good article from Pharmaceutical Technology covering the concept of overkill sterilisation cycles for steam sterilising cycles. 

J&J fined for off-label marketing

Yet more woes for J&J and its subsidiaries after the company was fined $2.2 billion for promoting off-label use.  A good reminder of the updated PV requirements of 2010/84/EU stipulating that all off-label & unlicensed use must be incorporated into the PV system.

USP update for particulate inspection

A new draft USP monograph has finally provided a definition for 'essentially free from particles'.  The definition involves a 100% inspection meeting an AQL of 0.65% or tighter for visible particles.  Subvisible particles remain unchanged. 

EMA's Risk Aversion

A very interesting article giving an insight into the EMA's thoughts on risk versus benefit during drug assessments and the potential shift to accept more uncertainty in their assessment.  It is an example of how competent authorities are incorporating ICH Q9 principles into their quality systems.  Some of these concepts may be of use in your decision making process for recall scenarios.

Responses to GMP updates

The EC has published comments from industry following draft updates to the GMP guide, GDP  and  excipient GMP.

Online QP training

Inspired Pharma have recently launched online medicinal chemistry QP training module with more modules scheduled for release over the coming months. 

Ian Hudson Interview

The Pharmaceutical Journal have published an interview with Ian Hudson, the newly appointed chief executive of the MHRA.  The interview highlights the increase in more specialist medicines such as biologicals and the increase in conditional authorisations. 

Compounding for death

US compounders are rarely out of the news and this article raises yet more questions. 

MS Vs MIA GMP

The MHRA have issued an interesting guidance document regarding GMP inspections of MS or 'Specials' licensed facilities.  'Specials' manufacturing is a predominately a UK based activity which allows MS license holders to manufacture large quantities of medications without the requirement for a marketing authorisation.  This general concept comes under the special clinical need umbrella as described in Article 5 of Directive 2001/83/EC.


The guidance document makes for some interesting comparisons and regulatory expectations compared to the EU GMP guide.  I've highlighted some below:

1.  Continuous Particle Monitoring

Clearly defined in Annex 1 to the EU GMP guide, continuous particle monitoring is required to be performed during the aseptic filling process.  The 'Specials' guideline (3.5.22 & 23) states that where closed systems are utilised (eg isolator technology) or where residual particle generation is unavoidable (eg IMS spray, opening needles) then the requirement for continous particle monitoring may be waved. 

This is a common sense approach by the MHRA.  Fill times for 'specials' can be short (eg minutes) compared to the commerical scale filling lines where fill times may fun for days.  Also the majority of starting materials used within 'specials' manufacture will be sterile, licensed medicinal products (eg vials of antitbiotics, cytotoxics etc).  Together with the closed system processing (ie the product does not contact the external environment) then the risk of particulate contamination is low.

2.  API controls

The FMD has introduced tight controls around the importation & distribution of APIs for human commercial products.  The 'Specials' guideline (3.5.3) states that the FMD and its transposition into UK law (SI 2013/1855) does not cover APIs used in 'Specials' manufacturing.  The guidance document goes onto explain that full supplier approval procedures are expected including supplier audits, desk audits etc.

3.  Dedicated Facilities

Updates to both Chapter 3 and 5 reiterate the requirement for dedicated facilities for products deemed necessary by the MIA holder.  Section 3.3.4 of the 'Specials' guideline states that dedicated facilities are not required where closed systems are used.  Most 'Specials' manufacturers will have dedicated isolators for penicillins but would often have single isolators for cytotoxics, monocloncals and non-penicillin antibiotics. 


These 3 highlights only provide a very brief overview of the MHRA's guideline.  It is well worth a read especially for commerical trainee QPs as a number of your products will be manufactured in 'specials' licensed units across the UK.

Friday's Round Up

A little late this week....

Counterfeit Xanax uncovered

More counterfeit drugs have been seized in Zurich.  It appears to have come from China and analysis of the products showed no active ingredient in them at all.

Thalidomide Overview

A great article describing the history of this well known drug and how it has been developed into treatments for cancer and leprosy.

Imigran Recall (UK)

A class 2 recall in the UK for the migraine treatment Imigran due to protruding needles.  A good example of how medicinal products are often combined with medical devices (eg needles/syringes) for drug delivery purposes.  Defects in these devices can be as significant as those to the drug itself so you need to be aware of the relevant functional testing of the finished product and delivery systems.

Paracetamol Suspension Recall (USA)

Another example of how a defect in a co-packaged medical device leads to a product recall.   The risk of overdose in paracetamol without graduated syringe markers is severe, hence the recall.  What would be your actions if this product was life critical with no alternatives?

Novomix Insulin Recall (UK)

A class 2 recall issued due to potential for variance in fill levels of insulin cartridges.  The drug alert is very comprehensive and provides detailed information for both patients and clinicians with regards to this recall. 



Happy Reading!