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!