Piramal  Clinical Trial Services
Piramal Healthcare is a global pharmaceutical contract manufacturer whose key activities include Active Pharmaceutical Ing...
Piramal Overview <ul><li>Annualised revenues of $720m </li></ul><ul><li>Total employees ~ 8750 </li></ul><ul><li>Sourcing ...
Strategic Acquisitions & Alliances 2005 2008 2002 2000 1996 1990 <ul><li>ICI Pharma, Cardiovascular portfolio </li></ul><u...
UNITED KINGDOM 1. MORPETH  API & Formulation Development & Manufacturing 2. GRANGEMOUTH Cytotoxic API Development & Manufa...
Morpeth History 1969 Established by G.D.Searle 1986 Monsanto acquisition of G.D.Searle Searle operated as a division 2000 ...
People and Environment Approximately 340 people employed Succession planning and talent management Learning resource centr...
Licenses MIA (IMP) 29595 Manufacturer's Authorisation  Investigational Medicinal Products MS 29595 Manufacturer's &quot;Sp...
Quality <ul><li>Proven QC/QA organisational capabilities </li></ul><ul><ul><li>QC sampling/testing/release activities </li...
Facility Capabilities <ul><ul><li>Fully integrated site </li></ul></ul><ul><ul><li>API   </li></ul></ul><ul><li>Includes p...
<ul><li>Piramal Clinical Trial Services </li></ul><ul><li>Packaging </li></ul><ul><li>Storage </li></ul><ul><li>Distributi...
<ul><li>Primary Packaging </li></ul><ul><ul><li>Fully Integrated Blister Line </li></ul></ul><ul><ul><ul><li>Standard tool...
<ul><li>Secondary Packaging </li></ul><ul><ul><li>Translations, Kit Design & Printing </li></ul></ul><ul><ul><ul><li>Appro...
<ul><li>Storage and Distribution </li></ul><ul><ul><ul><li>Approximately 3,000 dedicated locations </li></ul></ul></ul><ul...
<ul><li>Support Services </li></ul><ul><ul><li>QP Declaration and Certification Process </li></ul></ul><ul><ul><li>Drug Me...
Our overriding aim is to offer customers and patients an unsurpassed quality of service and product. What makes Piramal di...
Once we understand the scope we work hard to ensure that neither party ‘over commits’ and that we keep project activity fo...
Clinical Trial Service Process
A web based application used to track the status of manufacturing, distribution and drug returns Integrates with labelling...
TrakPack ®  – Reporting Examples Kit Compilation  Status   Quantity of kits completed, expected  completion date Electroni...
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Piramal Clinical Trial Services

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Piramal Clinical Trial Services

  1. 1. Piramal Clinical Trial Services
  2. 2. Piramal Healthcare is a global pharmaceutical contract manufacturer whose key activities include Active Pharmaceutical Ingredient, Product Formulation and Packaging from development to full commercial scale. Who are Piramal? Piramal Clinical Trial Services adds to our clinical trial manufacturing capabilities.
  3. 3. Piramal Overview <ul><li>Annualised revenues of $720m </li></ul><ul><li>Total employees ~ 8750 </li></ul><ul><li>Sourcing office in China </li></ul><ul><li>Robust growth @26% (FY08) </li></ul><ul><li>Number 4 in the Indian domestic market </li></ul><ul><li>Top 10 global custom manufacturing player </li></ul><ul><li>On-going investment </li></ul><ul><ul><li>Ahmedabad Facility </li></ul></ul><ul><ul><ul><li>Investment of $10 Million over 2 Years </li></ul></ul></ul><ul><ul><ul><li>Combined Development and GMP CT manufacturing </li></ul></ul></ul><ul><ul><li>Bangalore Facility </li></ul></ul><ul><ul><ul><li>Investment of $20 Million in sterile site </li></ul></ul></ul><ul><ul><ul><li>Two filling lines, one for CTM supply and one for commercial supply. </li></ul></ul></ul>
  4. 4. Strategic Acquisitions & Alliances 2005 2008 2002 2000 1996 1990 <ul><li>ICI Pharma, Cardiovascular portfolio </li></ul><ul><li>Chennai </li></ul><ul><li>Centre of Excellence </li></ul><ul><li>for Early phase API </li></ul><ul><li>Ahmedabad </li></ul><ul><li>Centre of Excellence </li></ul><ul><li>for Early phase Forms </li></ul><ul><li>Global Bulk Drugs FDA approved API facility </li></ul><ul><li>Avecia Pharma (UK & Canada) Global custom synthesis player </li></ul><ul><li>Pfizer Morpeth, Dosage form and Logistics </li></ul><ul><li>Haemaccel Brands Group of Plasma Select AG, Germany </li></ul><ul><li>Minrad International Inc. manufacture of inhalation anaesthetics </li></ul>Initial Indian Base Global Technical Capabilities Building CMO Assets <ul><li>Nicholas labs entry pharmaceuticals </li></ul><ul><li>Roche Products, ethical brands & vitamins </li></ul><ul><li>Boehringer Mannheim, diagnsitics portfollio </li></ul><ul><li>Sarabhai Piramal CNS & NSAIDS portfolio </li></ul><ul><li>Khandelwal Labs, Cefixim based drugs </li></ul>
  5. 5. UNITED KINGDOM 1. MORPETH API & Formulation Development & Manufacturing 2. GRANGEMOUTH Cytotoxic API Development & Manufacturing 3. BILLINGHAM Biocatalysis & Fermentation INDIA 1. MUMBAI R&D CENTRE API & Formulation Development 2. CHENNAI API Development & Manufacturing 3. HYDERABAD API Manufacturing 4. PITHAMPUR CTM Manufacturing 5. BANGALORE CTM Manufacturing CANADA 1. TORCAN API Development & Manufacturing Where are Piramal ?
  6. 6. Morpeth History 1969 Established by G.D.Searle 1986 Monsanto acquisition of G.D.Searle Searle operated as a division 2000 Searle/Pharmacia merged Solutia/Monsanto spun off 2003 Pharmacia acquired by Pfizer 2005 Pfizer to sell Morpeth 2006 Site acquired by NPIL 2008 Name change to Piramal Healthcare and re-branding
  7. 7. People and Environment Approximately 340 people employed Succession planning and talent management Learning resource centre The site has been continuously recognised as an “Investor In People” (the UK national standard for training & development) for over 16 years ISO 14001 awarded September 2005
  8. 8. Licenses MIA (IMP) 29595 Manufacturer's Authorisation Investigational Medicinal Products MS 29595 Manufacturer's &quot;Specials&quot; Licence MIA 29595 Manufacturer's/Importer's Licence Certificate of GMP Compliance of a Manufacturer Certificate No: UK ManA 29595/18244 - This covers human and veterinary products.
  9. 9. Quality <ul><li>Proven QC/QA organisational capabilities </li></ul><ul><ul><li>QC sampling/testing/release activities </li></ul></ul><ul><ul><li>Stability testing per ICH requirements </li></ul></ul><ul><ul><li>Method development & validation </li></ul></ul><ul><ul><li>QA EU Import testing & Certification/release </li></ul></ul><ul><ul><li>Four QP’s on Licence plus two 2 in training </li></ul></ul><ul><li>Quality Management Systems in line with FDA guidelines, ICH and structured to FDA Quality Systems Inspection approach </li></ul><ul><li>Regulatory Compliance group to support site and customer activities </li></ul>
  10. 10. Facility Capabilities <ul><ul><li>Fully integrated site </li></ul></ul><ul><ul><li>API </li></ul></ul><ul><li>Includes pilot plant and scale up capabilities </li></ul><ul><li>Pharmaceutical/drug product </li></ul><ul><li>Supply to USA & Far East </li></ul><ul><li>Pre-formulation & Pilot capabilities </li></ul><ul><li>Clinical Trial Manufacturing </li></ul><ul><li>Packaging </li></ul><ul><li>Modern equipment and facilities </li></ul><ul><li>Clinical trial services </li></ul><ul><li>Distribution </li></ul><ul><li>cGMP warehouse 7000 pallet locations </li></ul><ul><li>SAP system </li></ul><ul><li>Currently distribute over 100 countries </li></ul>
  11. 11. <ul><li>Piramal Clinical Trial Services </li></ul><ul><li>Packaging </li></ul><ul><li>Storage </li></ul><ul><li>Distribution </li></ul><ul><li>Reconciliation </li></ul><ul><li>As a specialised unit operating within the broader Piramal Healthcare organisation investigational drug supply process from comparator sourcing, manufacture, QP release and distribution through to patient kit returns and reconciliation </li></ul>What can Piramal offer?
  12. 12. <ul><li>Primary Packaging </li></ul><ul><ul><li>Fully Integrated Blister Line </li></ul></ul><ul><ul><ul><li>Standard tooling in different configurations reducing lead times </li></ul></ul></ul><ul><ul><ul><li>Customised design software, machine creates the design </li></ul></ul></ul><ul><ul><ul><li>Thermoforming and cold forming </li></ul></ul></ul><ul><ul><ul><li>3-D Blister tool design </li></ul></ul></ul><ul><ul><li>Bottle filling </li></ul></ul><ul><ul><ul><li>Full capability including HDPE, PP and glass </li></ul></ul></ul><ul><ul><ul><li>Desiccant & cotton coil insertion </li></ul></ul></ul><ul><ul><ul><li>In-line induction sealing, Ink-jet coding & check weighing </li></ul></ul></ul><ul><ul><li>Blister Card Walleting </li></ul></ul><ul><ul><ul><li>Rotary heat sealers including child resistant capabilities </li></ul></ul></ul><ul><ul><li>Over encapsulation </li></ul></ul><ul><ul><ul><li>Multi-Pharma MC100 machine </li></ul></ul></ul><ul><ul><ul><li>Compatible with size 00, 0, 1, 2, 3, 4 and DB capsules </li></ul></ul></ul>Principle Services
  13. 13. <ul><li>Secondary Packaging </li></ul><ul><ul><li>Translations, Kit Design & Printing </li></ul></ul><ul><ul><ul><li>Approved technical translators </li></ul></ul></ul><ul><ul><ul><li>Single and multi-panel/lingual labels and leaflets with over-printing directly on booklet label </li></ul></ul></ul><ul><ul><ul><li>Optical Character recognition for printed components </li></ul></ul></ul><ul><ul><ul><li>Validated open-label and randomised printing capabilities within GMP area </li></ul></ul></ul><ul><ul><ul><li>Electronic bar-code verification of printed labels </li></ul></ul></ul><ul><ul><li>Patient Kit Preparation and Compilation </li></ul></ul><ul><ul><ul><li>TrakPack ® generates assembly instructions and electronic verification of key steps </li></ul></ul></ul><ul><ul><ul><li>Automated label application of vials/syringes </li></ul></ul></ul><ul><ul><ul><li>Temperature sensitive packaging services </li></ul></ul></ul><ul><ul><ul><li>Just-in-time labelling </li></ul></ul></ul>Principle Services
  14. 14. <ul><li>Storage and Distribution </li></ul><ul><ul><ul><li>Approximately 3,000 dedicated locations </li></ul></ul></ul><ul><ul><ul><li>-20 °C, +2 to +8 ° C, +15 °C to +25°C continuously monitored & alarmed </li></ul></ul></ul><ul><ul><ul><li>Approved couriers and Cold-Chain vendors </li></ul></ul></ul><ul><ul><ul><li>Inventory management to the individual kit level </li></ul></ul></ul><ul><ul><ul><li>TrakPack ® management of IVRS and distribution process </li></ul></ul></ul><ul><li>Returns and Destruction Management </li></ul><ul><ul><ul><li>3-tier service offering </li></ul></ul></ul><ul><ul><ul><li>Processed within a dedicated area </li></ul></ul></ul><ul><ul><ul><li>Full audit trail through TrakPack ® </li></ul></ul></ul>Principle Services
  15. 15. <ul><li>Support Services </li></ul><ul><ul><li>QP Declaration and Certification Process </li></ul></ul><ul><ul><li>Drug Medication Sourcing – approved wholesalers </li></ul></ul><ul><ul><li>GMP Global Depots – Piramal QA audited </li></ul></ul>Principle Services Singapore Hong Kong Taiwan Korea Thailand Malaysia Philippines Indonesia France Australia New Zealand India Finland Estonia Israel Russia Ukraine North America Argentina Brazil Mexico
  16. 16. Our overriding aim is to offer customers and patients an unsurpassed quality of service and product. What makes Piramal different? Piramal take customer feedback very seriously. We want to get better at what we do, so it is important that we spend time talking to clients to find out where we can improve. We strive to offer continuity of relationships and agility for all customers, irrespective of project scope. Each customer is as important as the next.
  17. 17. Once we understand the scope we work hard to ensure that neither party ‘over commits’ and that we keep project activity focused on the real ‘value-add’ for the client. Customer service also means regular and rapid communications and a commitment to be transparent with information. We believe it is important to address issues early and honestly. Piramal follow a standard documented process which is mapped and procedural. What does ‘customer service’ mean?
  18. 18. Clinical Trial Service Process
  19. 19. A web based application used to track the status of manufacturing, distribution and drug returns Integrates with labelling software and uses barcodes to verify key stages of manufacture and distribution process Integrates with IVRS using HMTL & CSV formats to permit electronic transfer of data Provides be-spoke customer and site interface to view status of manufactured and distributed clinical trial kits How will I know what’s happening?
  20. 20. TrakPack ® – Reporting Examples Kit Compilation Status Quantity of kits completed, expected completion date Electronic Signatures Full audit trail of status changes to patient kit level IVRS order receipts Status of shipment order (received, processed, packaged, shipped, arrival) Expiry and re-test monitoring Returns Management Site & Deport stock reports Alerts on expiring stock based on client defined dates Patient kits returned, confirmed and full reconciliation Stock received, despatched and acknowledge to the patient kit level Report Data Reported

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