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 http://www.pharmaqmtraining.eu/brochures/falsified_medicines.html 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.

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Interesting developments about the Bolar Exemption

There are potential changes under consideration as described here .  The article also contains a link to a clear review of the current situation.  Hope this is of use.

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Get your Questions answered!

A 1-day non-residential course on
27 February 2014
at the Royal Society of Chemistry,
Burlington House, Piccadilly, London W1J 0BA, United Kingdom

 This Course gives you another opportunity to have your questions answered about the ‘Falsified Medicines Directive’ (FMD), which is one of the most significant pieces of pharmaceutical legislation to arrive for many years!

The urgent intention of the FMD is to protect European patients from receiving falsified medicines.

Outlined below are selected reasons why attendance at the Course might be important to position you as an up-to-date Regulatory or GMP Expert (or other person) in a role which requires your action, advice or other input into decisions being made for your company’s benefit.

If you are involved with the production of active substances you will need to take serious account of this new legislation and the various means by which its Articles have been, are being and will continue to be applied in the daily life of the global pharmaceutical industry.

In addition and not surprisingly there are many legal changes taking effect that impact on excipients, also intended to protect the public from falsified medicines.

Most EU companies, aiming to ensure compliance with the new law, face the prospect of carrying out a lot more international and European work.  However, it is not just European companies that are affected.  This EU legislation has major impacts on a substantial number of parties operating outside the ‘European Community’.

Companies and people involved in the distribution or other movement of pharmaceutical materials from one place to another or those who use, manage, supervise, regulate or give advice about these materials, to make intermediates or finished medicines, face new requirements.  That is likely to mean that there are new activities for you to know about and new actions to take.

Unless you are already sure that you understand fully the changes being required, you would be wise to book your place on our new Course.  We will deliver up-to-date knowledge and understanding to delegates to help them and therefore their companies counteract the menace of falsified medicines.

Please use the links on our site to learn more about the Course.  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 not delay if you want to secure a place.

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

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An excellent and varied panel of Speakers

In my previous post I emphasised how attendance at the Pharmaqmtraining.eu FMD course might enhance your performance as a ‘Regulatory or GMP’ Company Expert or other person such as a Freelance Consultant acting as an adviser to a pharmaceutical company or ancillary business.

In this post I want to provide you with information about the Team that will provide the training so that you can appreciate the extraordinary collective experience available to delegates and also see with whom you will have some networking opportunities on the day.

Chairman: Derek Calam is a Visiting Professor of Pharmaceutical Sciences, University of Strathclyde, a Member of the WHO Expert Panels for both Pharmaceuticals and Biologicals and Chairman of the WHO Committee responsible for allocating names to medical substances on a global basis.  He is a UK-nominated Expert at the European Medicines Evaluation Agency (EMEA) in London, and much more.

For over 25 years Derek has been advising the UK Regulatory Authority on quality matters concerning Chemistry, Pharmacy & Standards and Biological and Biotechnological Medicines.  He has also served as Chairman of the European Pharmacopoeia Commission, of the British Pharmacopoeia Commission and of the EDQM Steering Committee for Certification, Strasbourg.

SpeakersPaul Fleming is Technical Director of the British Generic Manufacturers Association (BGMA) which represents the views of the generic medicines industry in UK and has close and regular discussions with MHRA, other parts of the Department of Health and the NHS.  At a European level, Paul is a key Member of the Regulatory Committee of the European Generic Medicines Association, EGA. In both these roles, he is involved in the development and implementation of new regulatory guidance.

Paul has spent many years working for pharmaceutical generic companies in Europe at senior board level in roles covering drug regulation, pharmacovigilance and formulation development.  Previously, for six years he was a Pharmaceutical Assessor at the MHRA.

Geoff Mellor is Technical Director of the British Association of Pharmaceutical Wholesalers (BAPW) which represents full-line pharmaceutical wholesalers in the UK.  BAPW is a Member of the Brussels based European Association of Pharmaceutical Full-line Wholesalers, the GIRP.

Geoff leads for the BAPW on all technical, regulatory and liaison aspects and is the Association’s primary contact with the MHRA.  He is also a member of the GIRP Technical Committee, which covers aspects of health policy developments within the European Union.

Carl Mroz is the Director of Global Regulatory Affairs, EMEA for Colorcon Limited in the UK.  He is an active member of the International Pharmaceutical Excipients Council (IPEC) Europe, as the Chair of the Quality and Regulatory Affairs Committee and is also a Member of the European Pharmacopoeia Working Party on Functionality Related Characteristics, a Member of the British Pharmacopoeia Working Party on Excipients and the Panel of Experts on Inorganic Chemicals.

Carl is a past Chair of IPEC Europe and has been involved with the pharmaceutical industry for over 30 years in a variety of roles including Production, Quality Control, Regulatory Affairs and Quality Assurance.  He is an active international lecturer with particular expertise on compounded excipients used in conjunction with solid oral dosage forms.

Steve Porter is a highly experienced Quality Professional with over 35 years’ service in the Pharmaceutical Industry.  He is currently a Company Director at Steve Porter Pharma Consulting providing services in internal and supplier auditing, quality system design and enhancement, regulatory inspection preparations and remedial actions, design and delivery of training courses, supply chain design and evaluation, and QP services.  He is a Fellow of the Royal Society of Chemistry.

Steve has extensive auditing experience in the US, Europe and Asia (China, India, Japan). He has also served as a Board Member of IPEC Europe. He is an experienced International lecturer.

Until recently he was QA Director (Compliance), Global External Sourcing at Astra Zeneca. His many duties there included involvement with the company’s preparations for compliance with the Falsified Medicines Directive.

Mike Robertson designs our courses and he has created over 100 public conferences for other conference providers.  He is a Visiting Lecturer at King’s College, University of London and an experienced International lecturer.

Mike is an experienced freelance Pharmaceutical Regulatory and GMP Consultant at Pharmaceutical Quality Matters, a Quality Assessor on the WHO Prequalification Programme (Geneva – Copenhagen) and a scientific author on CMC and other subjects.

After more than 11 years in the pharmaceutical industry in QC & R&D operations Mike became eligible to register as a QP and then for 20 years, he worked at the Medicines Control Agency (MCA), now the MHRA in London, first as a Pre-Clinical (Nonclinical) Assessor and then as a Pharmaceutical Assessor.  He has also served on various bodies associated with the British Pharmacopoeia Commission, the EDQM and the European Pharmacopoeia Commission.

In total, a real wealth of expertise and experience!

Are you and your company up-to-date with the many developments arising from the FMD?

Look out for the next date for this Course and be sure to book your place quickly to avoid disappointment.  Places will be limited!

You can register your interest by clicking here.  Don’t be disappointed!

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Falsified Medicines (Quality Aspects): Tackling a major public health and safety problem

A 1-day non-residential course on
3 October 2013
at the Royal Society of Chemistry,
Burlington House, Piccadilly, London W1J 0BA, United Kingdom

The ‘Falsified Medicines Directive’ (FMD) is one of the most significant pieces of pharmaceutical legislation to arrive for many years!  The urgent intention of the FMD is to protect European patients from receiving falsified medicines.

Outlined below are selected reasons why attendance at the Course might be important to position you as a Regulatory or GMP Expert or other person in a role which requires your action, advice or other input into decisions being made for your company’s benefit.
If you are involved with the production of active substances you will need to take serious account of this new legislation and the various means by which its Articles have been, are being and will continue to be applied in the daily life of the global pharmaceutical industry.

In addition and not surprisingly there are many legal changes taking effect that impact on excipients, also to protect the public from falsified medicines.

Most EU companies, aiming to ensure compliance with the new law, face the prospect of carrying out a lot more international and European work.  However, it is not just European companies that are affected.  This EU legislation has major impacts on a substantial number of parties operating outside the ‘European Community’.

Companies and people involved in the distribution or other movement of pharmaceutical materials from one place to another or those who use, manage, supervise, regulate or give advice about these materials, to make intermediates or finished medicines, face new requirements.   That is likely to mean that there are new activities for you to know about and new actions to take.

Unless you are already sure that you understand fully the changes being required, you would be wise to book your place on our new Course.  We plan to deliver up-to-date knowledge and understanding to delegates to help them and therefore their companies counteract the menace of falsified medicines.

Please use the links on our site to learn more about the Course.  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 not delay if you want to ensure a place.

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

Leave a comment

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WHO SHOULD ATTEND FOR TRAINING ON THE FALSIFIED MEDICINES DIRECTIVE?

A new Course being held on 3 October 2013 in London on the FMD is expected to have a broad appeal because of its topicality and because so many parties involved with the pharmaceutical industry will be affected by the legislation.  If you are reading this, my guess is that your work role will be enhanced if you know about the new developments.

The Course should be of particular interest to many professionals, in the pharmaceutical and chemical industries and associated businesses, such as:

  • Qualified Persons (QPs), QP trainees, Auditors, Engineers, Scientists, Technicians
    working in Production, Development, Control, Compliance and Regulatory / Registration
  • Pharmaceutical Assessors, GMP Inspectors, Scientific / Medical Writers
    working in Competent Authorities
  • Staff working in Import, Distribution and Sales Departments / Companies

with interests in

  • Preparation and Control of Active Substances
  • Selection, Risk Assessment and Control of Excipients
  • Qualification of Suppliers
  • Formulation and Pharmaceutical Development
  • Pharmaceutical Quality System
  • Regulatory / Registration Departments
  • Purchasing and Supply of Substances for Pharmaceutical Use, Intermediates and Finished Medicinal Products

The title of the Course is

FALSIFIED MEDICINES (QUALITY ASPECTS)

Tackling a major public health and safety problem

Click here to see the course outline, speakers, venue, timings and more.

Book quickly as places are limited.

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Did you know that Germany ……

…. is the only country in the EU using border controls to apply the new API importation rules?

You will find out much more about the importation into the EU of active substances from third countries if you attend our Course on Falsified Medicines (Quality Aspects) which is referred to in more detail in the blogpost of July 20, 2013.

Book quickly to ensure your place on this highly-topical Course about a series of new developments with wide-ranging impacts.

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