7/31/2014 Indirect Food Additive GMP Training (Based on the current FDA's Good Manufacturing Practices Guidelines)

c = current G= Good M= Manufacturing P= Practices cGMP 7/31/2014 cGMP Training for Indirect Food Additives

cGMP is a set of regulations set forth by the U. S cGMP is a set of regulations set forth by the U.S. Food and Drug Administration (FDA) to help ensure that products intended for human consumption and use are safe. cGMP Training for Indirect Food Additives

U.S. FDA Regulates Food (human and animal) 7/31/2014 U.S. FDA Regulates Food (human and animal) Drugs (human and veterinary) Biologics Medical Devices Cosmetics Packaging for all above articles-Indirect Food Additives Food - (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. Food Additive - any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food. Includes any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food Plastics are cover as indirect food additive since they are used to hold food. cGMP Training for Indirect Food Additives

INDIRECT FOOD ADDITIVES Materials used to package food products are considered Indirect Food Additives Indirect Food Additives are not added directly to food products They are not intended to become a component of or a part of the food They come into contact with food as part of packaging, holding, or processing. cGMP Training for Indirect Food Additives

Indirect Food Additive Examples 7/31/2014 Indirect Food Additive Examples Adhesives Paper and Paperboard De-foaming agents Sanitizers Antioxidants Emulsifiers Lubricants Plastics cGMP Training for Indirect Food Additives 7/31/2014

7/31/2014 cGMP Paper and Paperboard can be considered indirect food additives if used to hold or package food Tergitol is a component of paper and paperboard used to package food Tergitol is a product that is produced in several stages at KMCO All stages of production, analysis and shipping of Tergitol must adhere to the cGMP practices to assure product quality A broad cGMP principle that runs throughout the regulations is the concept of redundant checks and balances to ultimately ensure product quality GMP Basics WRITE WHAT YOU DO – PROCEDURES000000000 FOLLOW THE WRITTEN PROCEDURES WHY ? - REGULATED INDUSTRY “IF NOT WRITTEN - IT WAS NOT DONE” “IF NOT WRITTEN - IT IS A RUMOR” cGMP Training for Indirect Food Additives

7/31/2014 Basic Elements of GMP Clearly define responsibility (Management, Quality) Design, build and maintain facilities and equipment Write and follow procedures Be competent (education, training and experience) Be clean Control for quality (sampling, change control) Document work (records management) Maintain traceability (Raw material through customer) Investigate customer complaints Audit for compliance A broad cGMP principle that runs throughout the regulations is the concept of redundant checks and balances to ultimately ensure product quality GMP Basics WRITE WHAT YOU DO - PROCEDURES FOLLOW THE WRITTEN PROCEDURES WHY ? - REGULATED INDUSTRY “IF NOT WRITTEN - IT WAS NOT DONE” “IF NOT WRITTEN - IT IS A RUMOR WHO IS RESPONSIBLE ? MANAGEMENT CAN DELEGATE THE AUTHORITY BUT NOT THE RESPONSIBILITY FOR QUALITY: MANAGEMENT IS RESPONSIBLE MANAGEMENT IS ACCOUNTABLE EVERY EMPLOYEE HAS QUALITY ASSURANCE RESPONSIBILITIES: Responsible for accuracy, authenticity and completeness of their work Responsible for following directions and written instructions Responsible for documenting their work Responsible for understanding the impact and consequences of change in systems, procedures and processing steps cGMP Training for Indirect Food Additives

Personnel Employees must have cGMP Training 7/31/2014 Personnel Employees must have cGMP Training Employees must wear clean clothing and appropriate PPE If employees are sick they should tell supervisor and take precautions to not contaminate product Consumption of food or drink, or use of tobacco is restricted to designated areas. Employees need to have document training in GMP, appropriate for job level. Employees who could come in contact with the materials need to wear clean clothing, i.e.. no dirty gloves etc. If they are sick need to tell supervision and take precaution to not contaminate the product. cGMP Training for Indirect Food Additives 7/31/2014

Building and Facilities 7/31/2014 Building and Facilities Must be of suitable size, design and construction to prevent mix-ups and contamination during: Receipt of raw materials Storage of raw materials, intermediates and final product Manufacture of Product Laboratory Operations Loading/Shipping of final product Facilities (reactors, tanks, lines etc..) must be dedicated or have documented cleaning procedures between different products to ensure contamination does not happen. Clean is the key Protect material from adulteration cGMP Training for Indirect Food Additives 7/31/2014

Building and Facilities-Plant Water 7/31/2014 Building and Facilities-Plant Water Must have process water supply that meets EPA’s Drinking Water Regulations KMCO’s Water Tank is sampled Quarterly and tested for compliance to Drinking Water Specifications Results are recorded and verified for approval Clean is the key Protect material from adulteration cGMP Training for Indirect Food Additives 7/31/2014

Building and Facilities-Pest Control 7/31/2014 Building and Facilities-Pest Control Must have a pest/rodent control program to protect non-bulk raw materials and all portable equipment and utensils from contamination from insects, rodents, birds, etc.. KMCO’s cGMP pest control vendor: Once per month visit or as needed Monitors around the two buildings used to store BF3 and Caustic tote. Only approved pesticides may be used Records of each visit are documented/reviewed Clean is the key Protect material from adulteration cGMP Training for Indirect Food Additives 7/31/2014

Building and Facilities-Housekeeping 7/31/2014 Building and Facilities-Housekeeping All cGMP facilities must have a documented housekeeping program Routine Housekeeping Audits are conducted at KMCO throughout the entire facility. Findings of these Audits are shared with each department Each department is responsible for all items found unacceptable in their own area. Records of how the finding was rectified are kept along with the accompanying audit. Clean is the key Protect material from adulteration cGMP Training for Indirect Food Additives 7/31/2014

7/31/2014 Equipment All Equipment used in cGMP processes must be KEPT CLEAN and well maintained. This includes vessels, transfer pipes, hoses, sampling equipment, stingers, totes… All hoses for the Tergitol processes should be dedicated. These hoses should be labeled and when not in use be cleaned, capped and properly stored to avoid contamination. CLEAN and keep clean cGMP Training for Indirect Food Additives 7/31/2014

7/31/2014 Equipment Exposed raw materials and cleaned portable equipment must be covered and stored to prevent contamination i.e.BF3 Totes and Caustic Totes-See SOP’s for details All measuring/sampling equipment must dedicated and be stored in sealed containers (i.e. sample catcher, strapping tape…) See OP685-cGMP Sampling Procedure and OP616-Cgmp Container Gauging. All sample bottles for cGMP processes must be stored in dedicated areas and remain clean and capped before use. CLEAN and keep clean cGMP Training for Indirect Food Additives 7/31/2014

7/31/2014 cGMP Procedures There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. cGMP Training for Indirect Food Additives 7/31/2014

cGMP Procedures Write what you do! Record what you do! Document All Procedures SOP’s, BER’s, OP’s, sub- processes… Follow the Procedures Record what you do! If not recorded, it was not done! All written records must be in pen. Any mistakes must be crossed out and initialed. cGMP Training for Indirect Food Additives 7/31/2014

7/31/2014 cGMP Procedures Manufacturing and product control have established written procedures. i.e. SOP’s (Standard Operating Procedures) , BER’s (Batch Event Records), cleaning procedures, transfer and filling instructions, in-process control methods, loading etc. All cGMP SOP’s and BER’s are labeled cGMP Process. Extra care must be taken when producing these products. cGMP Training for Indirect Food Additives 7/31/2014

cGMP Procedures Major equipment, transfer lines, containers and tanks that are used for processing, filling or holding indirect food additives must be identified. Using dedicated equipment is preferred If non-dedicated equipment is used, a thorough cleaning procedure must be followed before manufacturing a cGMP product. The cleaning process must be validated and results documented. cGMP Training for Indirect Food Additives 7/31/2014

7/31/2014 Production Only approved materials can be used to produce Tergitol. (Includes raw materials, processing materials and cleaning materials etc.) Weights/measurements of raw materials and finished products must be recorded on the batch job ticket. Each product used and produced must have its own unique lot or batch number which provides traceability throughout the manufacturing process. cGMP Training for Indirect Food Additives 7/31/2014

Production-Pump Seal Fluid 7/31/2014 Production-Pump Seal Fluid Pumps that have the possibility of their Seal Fluid contaminating the Tergitol product have been identified. These pumps are highlighted on the Preventative Maintenance checklist as using “Syntherm 700” only. This is a “food grade” oil that will not contaminate the product. Utilizing any other seal fluid rather than Syntherm 700 in these pumps will require that a management of change (MOC) be submitted to the customer. cGMP Training for Indirect Food Additives 7/31/2014

Management of Change Control 7/31/2014 Management of Change Control Any changes to the process and procedures used with Indirect Food Additives should follow a documented Management Of Change (MOC) process. This is a documented procedure that takes into consideration the impact of a change on the final product quality and performance. All MOC’s must be submitted to the customer for approval before change is instituted. cGMP Training for Indirect Food Additives 7/31/2014

Production-Shipping Product 7/31/2014 Production-Shipping Product Loading of finished Tergitol product must be done in a manner that maintains product quality. All gauging prior to and after loading must be performed with a dedicated cGMP gauge line. All Tergitol truck/ISO’s should be top loaded through a cover to keep any debris or trash from accidently contaminating the product. Shipping personnel should not have any items in their pockets that may fall into the product while loading. The retain sample must be caught using a dedicated cGMP sample catcher. cGMP Training for Indirect Food Additives 7/31/2014

7/31/2014 Laboratory Controls Raw materials, in-process samples and finished products are tested according to procedures provided by Dow to verify they are within specification and not contaminated. Samples of tanks, batches, raw materials and shipping samples are retained for one year and are stored in the sample retain building. Materials not meeting specifications are identified and controlled (Non-Conforming Material) to prevent their use. Must keep reserve samples! cGMP Training for Indirect Food Additives 7/31/2014

Non-Conforming Material 7/31/2014 Non-Conforming Material Non-Conforming material is material that does not meet all of the required specifications and/or characteristics. This can be Raw material, in process material, finished product or returned material. Non-Conforming material will be physically segregated when possible and tagged as such with a yellow Non-Conforming label. All actions involving Non-Conforming material will be captured in our CAPA (Corrective Action/Preventative Action) system. THE packaging area is clear. Look at the overhead area to make sure material does not fall from ceiling or process equipment into the containers. Maintaining traceability from raw materials through the customer using the material is critical! cGMP Training for Indirect Food Additives 7/31/2014

Complaints-CAPA System 7/31/2014 Complaints-CAPA System All customer complaints are recorded in the Corrective Action/Preventative Action system. Records include: Investigation into the root cause of the complaint Corrective action taken to prevent recurrence cGMP Training for Indirect Food Additives 7/31/2014

7/31/2014 cGMP Records Records must be kept at the time each action in the production of Tergitol is taken. Record what you do! If it is not recorded, it was not done! This is the key to cGMP compliance and ensures traceability. Audits are performed both Internal and by Dow to evaluate compliance to the cGMP procedures cGMP Training for Indirect Food Additives 7/31/2014

Conclusion Following the cGMP standard helps to assure the quality of the product produced. The quality control checks through every step of the manufacturing process help to ensure that the final product is of the highest quality, has been made in a consistent manner, and has not been contaminated. Take extra precautions when producing Tergitol! You and your family may buy food products that are packaged in materials made from the Tergitol we manufacture. cGMP Training for Indirect Food Additives 7/31/2014