1. 7/31/2014
Indirect Food Additive GMP Training (Based on the current FDA's Good Manufacturing Practices Guidelines)

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

3. 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

4. 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

5. 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

6. 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. 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 – PROCEDURES
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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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

26. 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

27. 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

28. 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