Sub-components in Nicotine cessation products? Mr Arun Sarda, Director of Quality and Regulatory Affairs Member of the HEITKAMP & THUMANN GROUP
Regulatory approval of sub-components in nicotine cessation products? Introduction to H&T Presspart Group - Pharmaceutical Pedigree Identifying the regulatory pathway for successful approval of Nicotine cessation products, using pharma/medicinal approved subcomponents? Regulatory strategy for sub-components used in the manufacture of Nicotine cessation products, using existing technologies, applying 40 years of know-how. 2
H&T Presspart s pharmaceutical pedigree 1970: Presspart Manufacturing is founded in Blackburn UK, manufacturing of industrial metal components and MDI (metered dose inhaler) cans. writer/title date 3
H&T Presspart s pharmaceutical pedigree 2009: Production of components and sub-assemblies of nasal inhalation devices begins at Presspart Tarragona, Spain writer/title date 4
H&T Presspart s pharmaceutical pedigree 2010: Novel plasma surface treatment process developed, offering unique surface treatment of the canister, minimising drug adhesion. 2011: Development of MDI actuators with integrated Dose Indicator and Dose Counter mechanisms begins at Presspart Tarragona. (Meet EOL indication regulatory requirements) 2012: Creation of the Presspart R&D facility, Inhalation Product Technology Centre (IPTC), Blackburn, UK. 2016: Presspart launches the first market-ready smart connected MDI (emdi). writer/title date 5
H&T Presspart today As a global market leader, H&T Presspart provides innovative drug delivery device solutions for clients in the pharmaceutical sector. Blackburn, UK Marsberg, Germany North Carolina, USA Shanghai, China Tarragona, Spain Mumbai, India Montevideo, Uruguay Manufacturing Sales Offices 6
H&T Presspart today 36 countries We maintain world-class manufacturing facilities and supply components and devices to 36 countries. 900 million In 2014, we manufactured over 900 million MDI cans, actuators assembled devices and plastic components. 400 employees We employ over 400 employees across our three European sites. [UK, Germany, Spain] 40 years We have over 40 years experience in manufacturing high volume components for the pharmaceutical market. 75% market share We manufacture components for over 75% of the world s MDIs. 8 million Over EUR 8 million invested in product development, manufacturing capabilities and capacities in 2014. 7
H&T Presspart today Our clients are world leaders within the Industry 8
H&T Presspart today Blackburn, UK site Aluminium MDI cans: Plain (uncoated) Plasma treated Anodised Stainless steel MDI cans MDI valve components Inhalation Product Technology Centre (R&D) Industrial & Speciality products Operate a ISO8 clean room writer/title date 9
H&T Presspart today- Marsberg, Germany site Aluminium MDI cans: o Internally spray coated Components for other OINDP (Orally Inhaled Nasal Drug products) devices, e.g. Respimat Clean Room environment & GMP writer/title date 10
H&T Presspart today- Tarragona, Spain site MDI actuator components and assemblies Speciality actuators for nasal, mouth and throat sprays Components & sub-assemblies for other drug delivery systems and medical devices ISO7 CR medical devices ISO8 CR plastic injection moulding writer/title date 11
Quality Management Systems ISO 9001: Quality Management Systems Presspart Blackburn originally achieved certification to BS 5750 (1980 s) Presspart Marsberg and Tarragona site both achieved ISO 9001 certification in 1997 ISO 15378: Primary packaging materials for medicinal products Presspart Tarragona became the first Spanish company to achieve certification in May 2008 ISO 13485: QMS for manufacture of Medical devices Presspart Tarragona achieved certification in June 2010 writer/title date 12
Material and product registrations H&T Presspart Drug Master Files filed with US FDA 07407: Aluminium Alloy MDI Cans 15078: MDI Cans Internally Coated with Fluoropolymer 16266: Stainless Steel MDI Cans 17299: Respimat Device Container 18569: MDI Cans Anodised and Internally Coated 21589: MDI Cans Internally Coated with FEP Fluoropolymer 23253: Veramyst Intranasal Device 30434: MDI Actuators 30520: Plasma Surface Treatment writer/title date 13
H&T Presspart and nicotine products US FDA Health Document Submission Requirements for Tobacco Products (Draft Guidance for Industry) Product Master Files from February 2017 (similar to Drug Master Files or pharma products). Why has the TPD been revised? 1) New scientific evidence emerged on tobacco flavourings and on the effect of health warning. 2) New products, such as e-cigarettes and strong flavoured tobacco products have emerged on markets. 3) Provide consistent regulatory framework for all Member States in EU. writer/title date 14
With the regulatory requirements and framework of the TPD (2014/14/EU) H&T Presspart are excited to be a key business partner in launching new innovative, safe, good quality products for the Nicotine Delivery industry. Do we think the components of Nicotine products in the future will contain a H&T Presspart MDI canister/sub-component(s) of some type? We think so. writer/title date 15
Thank You Member of the HEITKAMP & THUMANN GROUP Arun Sarda Global Director, Quality & Regulatory Affairs arun.sarda@presspart.com