Issue link: https://www.e-digitaleditions.com/i/377863
22 September 2014 Tablets & Capsules must check with regulators at the FDA or EMA before implementation to ensure their approach is acceptable. Yet both regulatory agencies have long supported QbD and have offered frameworks for implementing PAT. In fact, FDA representatives have spoken at numerous conferences and seminars about the advantages of continuous process- ing systems that incorporate QbD and PAT methodolo- gies. According to the FDA, manufacturing without inter- ruption fits the QbD concept since it provides many opportunities to adjust the process to meet a product's criti- cal quality attributes and thus protect patient safety. Still, the novelty of continuous tablet manufacturing has raised concern within the regulatory departments of pharmaceutical manufacturers, likely because it adds uncertainty to new drug applications. But again, the regu- latory agencies are willing to discuss the use of new tech- nologies, particularly when they incorporate PAT and QbD. As we designed and built our system, we met with officials from the FDA, EMA, and MHRA at the site to discuss our approach. We expect that these early visits by the people who will inspect and license the facility will help them understand and approve our customers' regula- tory submissions and/or help them conduct GMP audits or inspections of our site. Looking to the future API manufacturers have already adopted continuous processing, and equipment suppliers have long offered tablet presses and tablet coaters that can operate continu- ously. Now fully continuous tablet manufacturing has arrived and it will continue evolving as companies seek to manufacture more complex forms. Furthermore, with CDMOs like Aesica investing in this technology, phar- maceutical companies have a stronger incentive to pursue continuous processing and more will seek to use the process with their products. As the barriers to continuous processing disappear, the pharmaceutical industry is poised to change radically over the next 5 to 10 years. Changes will include new risk models to help companies stay competitive, as well as strong gains in efficiency and productivity from real-time quality assurance, as well as faster process development and validation. The benefits of continuous manufacturing are evident in other industries, and the amount of research activity and academic, commercial, and regulatory partnerships suggest we are witnessing the start of an overdue transformation. T&C David Ross is business development manager, finished dose, at Aesica Pharmaceuticals, Q5, Quorum Business Park, Benton Lane, Newcastle upon Tyne, NE12 8BS United Kingdom. Tel. +44 191 218 1960. Website: www.aesica-pharma.com 9_MVYWOHYTHOHUKSPUN The material matters in material handling 4-.=0(3;9(@ Won't bend, dent or deflect under heavy loads Smooth surface is easily cleaned Easy integration with process equipment More economical than metal; more durable than plastic 4-..,3*(7;9(@ 9LVLWXVDW 6XSSO\6LGH:HVW %RRWK $$36 %RRWK l a i r e t a m e h Th i t t m g n i l d n h l i t H T Y H O W Y V M _ 9 d n u t c e fl e d r o t n e d , d n e b t ' n o W e n a e l c y l i s a e s i e c a fa r u s h t o o m S h t i i t t i E N U P S K U H O H s d a o l y v a e h r e d d e t i e s s e c o r p h t i w n o i t a r g e t n i y s a E m ; l a t e m n a h t l a c i m o n o c e e r o M a g n i r b s e t i s o p m o c d e c r o fo n i e R u e c ma r ha p e h t o t e c n ma r o fo r e p . G F M s i P R F n i e m na g n i d a e l 0 5 0 6 - 8 5 4 ) 0 0 8 ( ee r fr - l l o t l l a C . m o c . y. a r t g fg m . w w w t i s i v r o t n e m p i u q e c i t s a l p n a h t e l b a r u d e r o m f o l e v e l w e n e l o h w e h t d n A . y. r t s u d n i l a c i t u Solid Dosage Training, Troubleshooting, and Problem Solving since 1989 Operator & Supervisor Training Your facility or ours • Formulating • Granulating • Tabletting • Blending • Coating • Packaging Get RESULTS! ANNOUNCING! TABLET TECHNOLOGY SYMPOSIUM OCTOBER 1-2, 2014 JOIN US! www.techceuticals.com