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!
