Applying a Knowledge-Based Approach to Pharmaceutical Supply Chain Temperature Control Management

Transcription

1 May 1-3, 2012 Javits Center New York, NY Applying a Knowledge-Based Approach to Pharmaceutical Supply Chain Control Management Arminda O. Montero Program Manager, Distribution QA Global Pharmaceutical Operations, Abbott Page 1 of 24

2 Pharmaceutical Distribution Model Distribution Suppliers Manufacturing End Customer Maintain product quality and efficacy throughout shelf life Page 2 of 24

3 From GMPs to GDPs (Good Distribution Practices) GMPs (Good Manufacturing Practices) GDPs (Good Distribution Practices) GMPs are not new, GMPs have been in effect for many years and are generally well understood GDPs while an extension of GMPs into the supply chain, GDPs are relatively new to supply chain partners (service providers and customers) Manufacturers control over the distribution network is much less than within manufacturing but quality systems/processes should be in place to maintain product quality and efficacy throughout shelf life Page 3 of 24

4 From GMPs/GDPs to Control Management Regulations / Guidelines / Standards WHO TRS No. 957 Annex 5 WHO TRS No. 961 Annex 9 EU GDP Guidelines (out for public consultation) IMB IA-G Canada GUI CFR Part 210, 211, 600 USP 1079 (out for public consultation) PDA Technical Reports 39, 52, 53 Multiple Worldwide Regulations, Guidelines and Standards Quality Systems Quality System Manual Quality Management Personnel Corrective Action and Preventive Action Complaints and Product Actions Documentation and Change Control Buildings, Facilities and Utilities Equipment Product Design and Development Validation Clinical Research Purchasing Controls Material Controls Production and Process Controls Packaging, Labeling and Promotional Material Controls Laboratory Controls Distribution, Installation and Servicing Controls Good Laboratory Practice for Nonclinical Studies Policy Control Management The quality system to maintain product quality and ensure compliance with global regulations and industry standards for the storage, transport and distribution of temperature-sensitive products Page 4 of 24

5 Control Management Control Management The quality system to maintain product quality and ensure compliance with global regulations and industry standards for the storage, transport and distribution of temperature-sensitive products OPERATIONAL PROCESSES PRODUCT REQUIREMENTS Qualification / Validation Supply Chain Partner Management Performance Management Communication and Education Continuous Improvement REGULATORY REQUIREMENTS Storage Shipping Excursions Stability Studies Ambient Profiles Passive Shipping Systems Active Shipping Systems Chambers Facilities Monitoring Distribution Validation Master Plans Quality Questionnaires Quality Assessments Quality Agreements Standard Operating Procedures Business Review Meetings Excursion Management Conformance Measurement and Reporting Root-Cause Analysis and CAPA Guidance Documents Training Modules Management Review Meetings Shipping Systems Monitoring Transportation Industry Trends Regulatory Trends Storage Shipping Excursions Stability Studies Page 5 of 24

6 Control Management Room Products and Stability Page 6 of 24

7 What Are Room Products? Refrigerated Products Room Products are not Frozen Products Ultra-Frozen Products Page 7 of 24

8 What Are Room Products? <30 C 20 to 25 C, excursions permitted 15 to 30 C <25 C 30 C 20 to 25 C 25 C 15 to 30 C 15 to 25 C 40 C, preferably 15 to 30 C 5 to 30 C <25 C, do not freeze 8 to 25 C 2 to 30 C 2 to 25 C <30 C, avoid temperatures above 50 C Page 8 of 24

9 Room Product Shipping Practices Room Product Shipping Traditional Practice New Practice Ambient Shipping (No Control, No Monitoring) Controlled Room Shipping and/or Monitoring Page 9 of 24

10 Why Controlled Room Shipping? 1. Increased Regulatory Focus Shipping Declarations Shipping Lane Qualifications New Regulations Audit Observations 2. Customers are asking about shipping temperature conditions (affiliates, government agencies, pharma companies, pharmacies, patients) 3. Need to protect product from extreme and unsupported ambient temperature exposure Page 10 of 24

11 New Regulations Saudi Arabia FDA December 2010 Page 11 of 24

12 New Regulations UAE MOH January 2011 Page 12 of 24

13 New Regulations European Commission July 2011 European Commission Guidelines on Good Distribution Practice of Medicinal Products for Human Use issued for consultation July 2011 Page 13 of 24

14 Ocean Ambient s North America to Europe Shipment 1 Shipment 2 Shipment 3 Shipment 4 Page 14 of 24

15 Air Ambient s from North to South America Shipment 1 Page 15 of 24

16 Air Ambient s from Japan to North America Shipments 1 through 3 Page 16 of 24

17 Room Product Shipping Practices Room Product Shipping Traditional Practice New Practice Ambient Shipping (No Control, No Monitoring) Controlled Room Shipping and/or Monitoring Page 17 of 24

18 Room Product Label Claim Soup <30 C 20 to 25 C, excursions permitted 15 to 30 C <25 C Label 30 C Claim 20 to 25 C 25 C 15 to 25 C 15 to 30 C 40 C, preferably 15 to 30 C Soup 5 to 30 C <25 C, do not 8 to 25 C freeze 2 to 30 C <30 C, avoid 2 to 25 C temperatures above 50 C Page 18 of 24

19 Room Product Label Claim Soup Page 19 of 24

20 Room Product Label Claim Soup 5 to 30 C <25 C <30 C, avoid temperatures above 50 C Page 20 of 24

21 Room Product Stability Standardization Label Claim Soup PRODUCT CONDITION STABILITY RANGE STABILITY STUDIES <30 C 20 to 25 C, excursions permitted 15 to 30 C <25 C 30 C 20 to 25 C 25 C 15 to 30 C 15 to 25 C 40 C, preferably 15 to 30 C 5 to 30 C <25 C, do not freeze 8 to 25 C 2 to 30 C 2 to 25 C <30 C, avoid temperatures above 50 C Room Product Stability Standardization STORAGE SHIPPING 2 to 30 C 2 to 30 C or wider as supported by product stability 1. Long Term Study 2. Accelerated Study 3. 5 C Refrigerated Study C Excursion Study EXCURSIONS Down to -20 C Up to 50 C C Excursion Study Page 21 of 24

22 Stability Testing Guidance Documents Stability Testing Guidance Documents WHO TRS 953 Annex 2 PDA PCCIG Guidance STABILITY STUDIES ICH Q1A(R2) (2003) (2009) Documents Technical Report 39 (2007) Long-Term Guidance Guidance references ICH and WHO PDA TR 39 provides guidance on stability testing to support product distribution temperature conditions, which include storage, shipping and excursions This stability testing guidance complements the standard longterm and accelerated stability testing Accelerated Guidance Guidance Technical Report 39 (2007) references ICH and WHO Cycling / Excursion No Guidance No Guidance PDA Technical Report No. 53 Guidance for Industry: Stability Testing to Support Distribution of New Drug Products Published in 2011 Page 22 of 24

23 Control Management Control Management The quality system to maintain product quality and ensure compliance with global regulations and industry standards for the storage, transport and distribution of temperature-sensitive products OPERATIONAL PROCESSES PRODUCT REQUIREMENTS Qualification / Validation Supply Chain Partner Management Performance Management Communication and Education Continuous Improvement REGULATORY REQUIREMENTS Storage Shipping Excursions Stability Studies Ambient Profiles Passive Shipping Systems Active Shipping Systems Chambers Facilities Monitoring Distribution Validation Master Plans Quality Questionnaires Quality Assessments Quality Agreements Standard Operating Procedures Business Review Meetings Excursion Management Conformance Measurement and Reporting Root-Cause Analysis and CAPA Guidance Documents Training Modules Management Review Meetings Shipping Systems Monitoring Transportation Industry Trends Regulatory Trends Storage Shipping Excursions Stability Studies Page 23 of 24

24 Thank you Page 24 of 24