Do you know the answers?

An API manufacturer (“Mumbai Pharma Substances”) based in India wants to export an active substance from Mumbai to

(i) Kenya and to

(ii) France.

What steps should Mumbai Pharma Substances take / have taken to ensure that these export sales proceed smoothly in the context of recent regulatory changes in the European Union?

A drug product (dosage form) manufacturer based in France wants to purchase an active substance from Mumbai Pharma Substances and take delivery at the French factory site.  Two delivery routes are being considered:

(i)  air freight by direct flight from Mumbai to France, followed by secure storage at the French airport pending road transport with direct delivery to the French factory,

(ii ) air freight by direct flight from Mumbai to the UK, with secure storage first at the UK airport and then at a MHRA-licensed UK facility pending onward transport by road directly to the French factory.

What issues come to your mind concerning compliance with the recent regulatory changes in the European Union?

A Marketing Authorisation Holder in the UK has approval to manufacture its generic product in India and in Germany, for the purpose of supplying the UK market.

Compare and contrast the regulatory issues that affect each of these two sources, in the context of recent regulatory changes in the European Union.

Does your Company source APIs from outside the EU (i.e. from a third country)?  When it comes to sourcing APIs what is meant by listed and non-listed third countries?  Where can I find the list and which countries are listed?

What is a written confirmation?

What is an Atypical Active Substance?

My company’s risk assessment against the use of the excipient lactose has concluded that this is high risk.

As part of the company’s risk mitigation procedure, I need to carry out an audit of the manufacture of this material.  Which audit standard can I use for this which will be acceptable to the inspector?

The company uses sodium benzoate as a preservative in one of the oral liquid products which we manufacture.  As our requirement is only 15 kg per year we source this excipient via a UK distributor.  However as this distributor refuses to identify the actual manufacturer I am unable to perform the required risk assessment on this material.  What should be my actions in this case?

My Company uses the same grade propylene glycol as an excipient in pharmaceutical products which are used both topically and parenterally.

The risk assessment concludes that this excipient is both ‘low risk’ and ‘high risk’ simultaneously.  How to I approach this with the supplier?

I am importing from South Korea a cellulosic material which meets the requirements of the PhEur and using it as the active component of an ophthalmic product for the treatment of ‘dry eye’.  The manufacturer will not guarantee that the material is manufactured in accordance with GMPs for active pharmaceutical ingredients, but does certify that it is manufactured in accordance with appropriate excipient GMPs.  What are my options?

“What are the main changes with the directive for the wholesale supply chain?”

“What policy do you support with regard to the checking of goods to ensure no counterfeits enter the UK wholesale supply chain?”

“What principles do you support on the product pack and coding for the unique identifier?”

“What are the significant challenges and cost implications for wholesale suppliers in adopting the new legislation?”

My company only purchases a small quantity of API each year from broker based in the UK who in turn purchases the API from an Indian API manufacturer. Do I need to audit both the broker and the manufacturer?

The API manufacturer has already been inspected by both the FDA & Danish authorities; do I still need to do an on-site audit?

“The API company in India will only allow a one day audit; what are my options?”

“As a QP what do I need to know about my API suppliers before I certify that the drug product is suitable for release?”

“Will all generic medicines end up needing to carry the tracking device and tamper evident seal?”

“Can a track & trace system that relies on an EU wide IT system ever work quickly enough in practice?”

Is a UK only system for track & trace possible?

Please use the links on our site at to learn more about the Course, which is confirmed to proceed in London on Thursday 27th February 2014.  There is information available on the main subject areas of the training, on the excellent panel of speakers and on the delegate package, which is priced to be attractive.  You will find it easy to make your booking and you should definitely not delay if you want to secure a place.  Delegate numbers will have to be finalised soon, so act now to avoid disappointment.  

We look forward to meeting you and to sharing a lively programme with good sessions dealing with your questions.