October 16, 2013

This issue’s contribution comes from Dr. Paolo Biffignandi’s colleague Lini Subin, a Senior Regulatory Affairs Manager at pan-European regulatory affairs organisation ELC Group. With almost a decade of expertise in global pharmaceutical regulatory affairs and holding an MSc in Chemistry (Pharmaceuticals), Lini Subin is a knowledgeable strategist who understands the entire application lifecycle, from pre-approval to post-approval activities. Well versed in EU DC/MR and ICH national strategies, her specialities include dossier development for a variety of markets, including Europe, Asia, Africa, Latin America, CIS countries and the US. She is also an expert in managing eCTD/NeeS conversions and MA transfers. Based in India, her insightful knowledge of market trends gives her a unique perspective on implementing business development initiatives.


 On 4 July 2013, the European Medicines Agency (EMA) published the ‘Draft concept paper on the need for revision of the note for guidance on manufacture of the finished dosage form (EMA/CHMP/QWP/324350/2013)’ for consultation.

The existing guideline ‘The note for guidance on manufacture of the finished dosage form (CPMP/QWP/486/95)’ came into operation in 1996. Since then, many other quality guidelines, references to directives and formats of dossier have been changed. Additionally, manufacture of a variety of finished dosage forms is gaining worldwide attention. Duly, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed the new guidance ICH Q8(2), Q9(3), Q10(4). In this scenario, technical terms such as the holding time of bulk products, are now an important part of the description of manufacturing process. This necessitates the revision of the existing guideline. The objective of the EMA concept paper is to address the need to update and revise the current guideline.

The guideline on manufacture of the finished dosage form underlines all aspects of manufacture that are important for both applicant and regulator. The concept paper outlines some of the aspects that are mentioned in the current guideline and that need revision/updating as per new development. For example, the guideline indicates that information which falls under GMP should not be part of the MA file and that only product-specific issues need to be described. Hence the intention of revision is not to repeat the information provided in other guidance documents or create new guidelines but to update the information in line with recent development.

The following recent aspects should be described in the new guideline as they impact on the drug’s manufacture, for example:

• holding time conditions of bulk product

• ongoing revision of guideline on process validation and real-time release testing

• ICH guideline Q8 on Pharmaceutical Development, Q9 on Risk Management and Q10 on Quality Systems

• shipping transportation conditions

It should then follow CTD structure.

The Quality Working Party now recommends the revision of the Note for Guidance on manufacture of the finished dosage form and updating the information about manufacture of finished dosage form in line that the with recent development and the current EU legislation. It is anticipated that the draft guideline could be available six months after adoption of the concept paper and that this would then be released for external consultation for six months before its finalisation within another six months. It is also expected that requirements for regulators and industry will be better clarified in the updated guidance, taking into account the concepts of recent development. The consultation period for this concept paper is open until 31 December 2013 and the Committee for Medicinal Products for Human Use (CHMP) invites comments from interested parties.  


Lini Subin, lini.subin@elc-group.com.

October 16, 2013

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