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)



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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. 



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