Quality in Global Sourcing

Transcription

1 Quality in Global Sourcing Steve Greer Global Compliance Leader P&G Beauty & Grooming Current Challenges 1

2 Supplier Related Incidents High profile material contamination incidents have highlighted risks of potential illness, injury, or even fatalities in the consumer population 3/07 Melamine in Pet Food 7/07 DEG in Toothpaste & Cough Syrup 8/07 Lead Paint on Toy Trains 9/07 Acrylamide Monomer in Skincare 8/08 Heparin Contamination 9/08 Melamine in Baby Formula 1/10 J&J recalls due to odor & GI effects from chemical on pallets 3/10 Salmonella in Hydrolyzed Vegetable Protein Today s Realities We spend billions of dollars with suppliers Material quality is critical to our product performance and often defines our products With the pressures of productivity improvement fewer resources are available for supplier quality management Our supply chains are more global & more complex than ever Regulatory requirements & expectations are increasing daily 2

3 Margaret A. Hamburg, M.D., Commissioner of FDA Protecting Health: FDA s Global Challenge First, we are seeking better controls at the point of production A second key element of our strategy is to hold importing companies responsible for their supply chain. Some companies already do a terrific job keeping tabs on where and how their products are made and the path taken to reach our shores. On the other hand, companies that sell contaminated products because of loose supply chain oversight need to face serious penalties and cannot excuse themselves by blaming their suppliers, blaming the FDA, or blaming anyone else. Only when everyone involved shares responsibility for safety will we succeed in our mission. Office of Compliance: Selected Enforcement Priorities for 2011 Drug quality in OTCs Assure investigations (complaints, rejects) are prompt and correct root causes Data Integrity and quality systems Supply chain security Contract manufacturers Raw material/excipient vendor qualification programs Combating economically motivated adulterated products/ingredients Field Alert Reporting Contaminated, sub or super potent, high risk compounded drugs Internet health fraud Marketed unapproved drugs Post-market adverse event reporting 6 3

4 FDA Focus on Secure Supply Chains The agency has issued assignments to take samples of API s and is planning to expand the program to excipients. The FDA is working on a component rule (being drafted on fast track) Know your supply chain, the original manufacturers and subsequent handlers perform a physical audit at the original manufacturer s site Sample and test each container Require tamper-evident packaging and security features Notify FDA of contaminated shipments and lots FDA Focus on Secure Supply Chains We feel that having an audit requirement in [21 CFR Part 211] is a necessity, so the component rule will actually have a requirement for auditing raw materials suppliers and other controls we think can be emphasized or enhanced, Edwin Rivera-Martinez, CDER s Acting Director for Drug Quality Assurance While some companies inspect and hold their suppliers to strict standards, there are many others who aren t, and they re depending on strategies that don t make a lot of sense. One of those strategies is requiring a certificate of analysis. That piece of paper probably doesn t mean as much as you would hope it means. Michael Chappell, FDA Acting Associate Commissioner for Regulatory Affairs 4

5 The Rules of the Game are Changing Government More rigorous enforcement of regulations coupled with new regulations Mandatory auditing, testing, and agreements Holding manufacturers accountable Suppliers Globalization of supply chains No proof of compliance with regulations, quality assurance expectations Companies Greater challenge in protecting our consumers and our reputation Supplier Stories 5

6 Supplier Auditing Not for the Fainthearted Supplier GMP? 6

7 Organizing for Success 7

8 Vision P&G s Quality Assurance organization will: develop and deploy common systems and tools globally and across business categories ensure materials are safe, comply with applicable regulatory and environmental requirements, and meet specification. Policies & Procedures Policy 35 Material Control SOP 38 QA Key Elements SOP 20 Material Spec Format & Content SOP 22 Supplier Material Quality Management CQG 41 Incoming Material Management CQG 42 Supplier Assessment and Auditing 8

9 Organization Material quality leaders per business unit global material quality team Qualified supplier auditors in each region Material supply managers at manufacturing sites and central leaders Supplier Data Global supplier database audit history & reports Supplier scorecards multi-functional 9

10 Quality Risk Management Supplier Quality Benefits of Supplier Risk Management Determine how to best leverage limited resources Identify areas of greatest vulnerability to ensure sufficient supply continuity plans are in place Determine supplier qualification status Identify the level of quality control appropriate prior to use 10

11 Quality Risk Management 101 ICH Q9 Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the product across the product lifecycle. Supplier Quality Risk Prediction Matrix Identify risk areas to evaluate Material Impact Supplier Location Supplier Performance & History Site Risk Supply Chain Risk Etc. Determine rating system 5 Major impact, risk 3 Moderate impact, risk 1 Low impact, risk Define weighting approach & scale Addition or Multiplication Break points for risk classification 11

12 Material Impact Criteria Risk Category & Rating 5 A Material application, use, and impact. Health/Safety, Regulatory Considerations Major impact on Finished Product quality, performance. and stability Material functionality is critical to product performance Regulated materials and regulated risk is high 3 Minor impact finished product quality & performance Material contributes to functionality of the product Non-regulated materials No impact on finished product quality & performance 1 Material is non-functional in the product Commonly used Industrial materials (with industry standards) Easy to inspect and test. Easily identifiable in the product or process. Raw Material Example Zinc Oxide, USP Grade Supplier located in Taiwan Good history of performance No rejections, lots with out-of-spec results, no quality issues in > 10 yrs of use Not a dedicated production facility Site qualified via GMP questionnaire Third party audit 2009, most corrective actions effective Company audit 2010, some major observations Material is provided via a distributor 12

13 Raw Material Example Material application, use, and impact. Supplier Location Supplier Performance and History Supplier Manufacturing Site Risk Supply Chain Risk Overall Risk Rating # Risk Rating and Reason 5 - Material is the active ingredient in OTC drug. Major impact on the finished product performance. 5 - Taiwan is in a high risk region. 1 - Long history with this supplier and performance is good. 3 - Not a dedicated production facility. Supplier's corrective actions from 3rd party audit were mostly effective, but several major observations in the subsequent company audit 3 - Material is supplied via a distributor 17 - High Risk Risk Prediction Approach Determine how to evaluate a supplier if they provide multiple materials For new suppliers, risk prediction can be a helpful tool in the qualification process Risk prediction scores should be updated on a scheduled basis and more frequently if factors change 13

14 Using the Risk Prediction Score Determine type of audit required and frequency Prioritize suppliers to audit Aids in determining resource needs Helps identify which material quality management tools to apply Supports reduced testing programs at manufacturing sites Designing Quality Into Sourcing Relationships 14

15 Integration of Quality Expectations Capturing quality requirements in typical purchasing contracts is essential but not sufficient Depending on the strategic importance of the supplier, invest effort in teaching your quality philosophy, tools and experience Leverage Quality Agreements, where appropriate, to formally establish expectations Quality Agreements Born in the pharma industry in the UK in 1991 ICH Q7a GMP Guide for API s (Suppliers) Section 16: There should be a written and approved contract or formal agreement between a company and its contractors that defines in detail the GMP responsibilities, including the quality measures, of each party. ISO Cosmetics GMP Guideline (Contractors) Section 12.1: A written contract or agreement should be established, mutually confirmed and controlled between the contract giver and the contract acceptor covering subcontracted activities. The objective of this step is to obtain a product or service which complies with the defined contract giver requirements. 15

16 Key Elements of Q Agreements Clearly defined responsibilities for both Documentation approach Change management Handling deviations and complaints Materials management Release process Auditing Sub-contracting Urgent Changes Needed!!! The need for senior management to take responsibility for their selection and qualification of the Ingredient suppliers, including their supply chains. Need for firms to similarly have better programs for qualification their contract manufacturers. Both supplier and contract manufacturers can be selected and monitored via an external audit program (future possible approach)

17 Key Takeaways The rules of the game have changed consumer product companies must ensure they have strong quality assurance over their supply chains Risk management tools can be very useful to leverage resources and guide the supplier quality program Quality needs to be designed into the supply chain Challenges in Assuring Supply Chain Integrity Complexity & Hazards Ref: The American Council on Science and Health, August 2006, Counterfeit Drugs <

18 Steve Greer Global Compliance Leader P&G Beauty & Grooming 18