The contamination control strategy or CCS is the overarching document that will serve to define your critical contamination control points from all angles; design, procedural, technical and organisational. How might you identify these critical contamination control points? Quality Risk Management and risk assessment!

Pretty much anything and everything can be outsourced in today’s modern pharmaceutical industry.

Which is both a blessing and a curse. Moving activities from in house does mean that the contract giver gets the advantages of scale and expertise offered by organisations dedicated to a particular activity.

The contract acceptor can concentrate on what they do well, investing in technology and improvements.

However, the contract giver then has the headache of oversight of multiple organisations and the contract acceptor has to meet the expectations different customers.

In general terms, as I’m sure you’ll all know, there have been BIG changes. The first obvious difference is the sheer size of the annex, up from a mere 16 pages to a hefty 52 in the new version.

Annex 16 and 13 use the wording “preferably in the form of a diagram”.

We don’t see the word preferably very often in GMP guidelines.

We see “should” often, but what does “preferably” mean? …

“I found the mock sessions fairly difficult to begin with, I would walk in thinking I knew everything backwards and walk out wishing I had trained in a different EU member state.

My frustration was less due to a lack of knowledge and more due to the fact that I struggled to structure an answer in such a manner that demonstrated competence.”

Being a QP Sponsor is a lot like being a driving instructor

You are giving your trainee support and insight into the real world of the QP rather than just the academic side of things.

Being a QP Sponsor is a rewarding experience which supports your own career growth and continuing professional development.

The Sponsor or Mentor of a QP trainee must know that person professionally

I.e. they must work with that person in some capacity so that they can observe their work activities and behaviours and sign off the Sponsors report in good faith.

… top tip number one, start your form as soon as you decide to follow the QP career path. You already have lots of relevant experience that you can put in. This gives you a starting point and avoids the horror of the blank page…

Here we will look at the QP Declaration for Investigational Medicinal Products (IMP) which are those medicines being studied in Clinical Trials, including any placebo or comparator.

The QP Declaration for IMP is significantly different from the API QP Declaration…

QP Declarations are used to document that a holder of a medicines authorisation has done all the required due diligence regarding the GMP status of their product. Here we will look at

• The scope of API QP Declarations

• Where GMP starts

• Audits

• Responsibilities

Here are the steps you need to succeed in Root Cause Analysis, be sure you don’t miss any.

I often say that Annex 16 should be the QPs teddy bear, held close and treated with love.