Ashland Specialty Ingredients IFAC’s cGMP Audit Guide How the Food Ingredient Industry has Responded to FSMA and Food Safety Audits Priscilla Zawislak Global Regulatory Affairs Manager IFT Annual Meeting July 16, 2013

2 Ashland Specialty Ingredients IFAC’s cGMP & Audit Guide – WHY? Current Good Manufacturing Practices (cGMPs) are about preventive controls which are necessary for food additives per 21 CFR 110 with a focus on food safety risks: –Foreign materials –Labeling (such as allergens) Food Safety Modernization Act (FSMA) elevates food safety to outline guidelines for HARPC FDA’s draft Preventive Controls Rule does not address the unique needs of food additives

3 Ashland Specialty Ingredients IFAC’s cGMP & Audit Guide – WHY? Processes for manufacturing food additives are often different than manufacturing finished foods –Food safety risks are often different –Different preventive controls & cGMPs are needed Food industry 3 rd party audit standards, e.g. GFSI audit programs, do not have the flexibility needed for food additives Most customer and 3 rd party auditors are not familiar with food additive manufacturing

4 Ashland Specialty Ingredients IFAC’s cGMP & Audit Guide – WHY? The IFAC guides adapt cGMP requirements and 3 rd party audit standards to food additives –Most food safety audit standards are similar but interpretation of the provisions as they apply to food additives varies –Provide auditors with a more relevant guide for conducting food additives audits

5 Ashland Specialty Ingredients IFAC cGMP Audit Guide IFAC developed a recommended guide for the safe manufacture of food additives The IFAC cGMP Guide presents a focus on food additive production vs a general overview per 21 CFR 110 Also applicable to these materials for use in dietary supplements Provides a more unified approach to these principles for food additives Covers the Quality Management System (QMS) & cGMPs necessary throughout manufacturing for both batch and continuous processes to prevent food safety problems Covers FSMA requirements applicable to food additives

6 Ashland Specialty Ingredients Hazard Assessment & Risk Management A science & risk-based approach is needed to identify and implement appropriate practices and procedures necessary to protect against contamination of products –Food additives represent a wide range of products with varied processing technologies –Food additive grades may only be manufactured a few times/year in a process that makes industrial to pharmaceutical grade products –Food additives must meet established specifications and cGMP requirements even though some food additives may undergo additional processing before reaching the consumer

7 Ashland Specialty Ingredients Food Additive cGMPs Risk Management and Change Control are key elements in the QMS and cGMPs –Focus is on prevention vs reacting to problems that could cause food safety events Identify hazards Implement steps to minimize or prevent hazards Identify monitoring procedures Record results Specify actions to correct problems that arise –Many food additive companies have had these systems in place for a long time to meet pharma requirements

8 Ashland Specialty Ingredients Change Control/Management of Change Changes are evaluated to assess the impact on the quality and the safety of the food additive Programs are in place for raw material and supplier qualification Management of Change is used to request & document changes and includes an evaluation of impact on HACCP and cGMP products Management of Change for process safety has been an established practice by many companies in our industry for decades, often….

9 Ashland Specialty Ingredients Food Additives vs Finished Foods GMPs & Food Safety Differences

10 Ashland Specialty Ingredients Differences in Hazard Analysis Environmental Risks & Monitoring –While some food additives are not high risk for microorganisms Most do not have compendial micro specifications Many processes and raw materials minimize microbial contamination risks –Environmental pathogen testing has its place in the hazard analysis Manufacturing environment is part of the hazard analysis –Packaging areas practices follow cGMP guidelines to mitigate potential for product adulteration, contamination and mislabeling

11 Ashland Specialty Ingredients Differences in Hazard Analysis Sanitation & Hygiene Practices & Controls –Different controls & cleaning requirements for batch vs continuous processes –Gloves & PPEs protect against physical & environmental hazards and there is usually little or no direct handling of product by production personnel –Special practices usually only needed for products that are more sensitive to contamination –Controls must be suitable for a wide range of products and conditions –Hygiene & training best practices are tailored based on the risk assessment for food additives

12 Ashland Specialty Ingredients Differences in Hazard Analysis Food Safety Plan –Many plants manufacture excipients and personal care ingredients in addition to food additives in the same processes under similar controls –Supplier & raw material qualification needs are focused on quality and suitability for intended use Food Defense Plan –Food additive plants typically have multiple levels of security to control access to areas –Intentional contamination risks are low –Most food additive suppliers have established programs to ensure supply chain security

13 Ashland Specialty Ingredients Differences in Hazard Analysis Allergen Control –Must be risk-based A control plan should be based on risks –Procedures for setting allergen control requirements should be practical Focus on potentials for cross-contamination including raw materials storage, production areas, packaging areas and warehouses

14 Ashland Specialty Ingredients Summary Risk assessment, change management and implementation of preventive controls for food additives is essential to production of a product suitable for its intended use Economically motivated adulteration & other contamination is controlled through adherence to cGMPs, including supplier qualification & verification for raw materials Flexibility is needed to adapt required controls to the unique situation and allow companies to identify best practices and preventive controls to enhance food safety and consumer health without being overly burdensome

15 Ashland Specialty Ingredients Next Steps Publication of IFAC GMP Audit Guide IFAC webinars on cGMP & Audit Guide Industry communication & awareness Goal - adoption by 3 rd party food safety auditing organizations Goal - recognition by US FDA

16 Ashland Specialty Ingredients Thank You!