GMP QUESTIONNAIRE Personnel and Company Background Part I 1.

Supplier Name, address and telephone number

2. Address and telephone number of supplier agent in the US

3. Company representative and title 4. Please provide a list of products you produce:

5. How many employees at this location work in Production and the Quality Unit? Production Quality Unit Full-time ________ _________ Part-time ________ _________ Temporary ________ _________ Contract ________ _________ Personnel and Company Background Part II Is the facility registered with the FDA? If yes, what type of registration? YES X NO N/A

Has the facility ever been inspected by the FDA? Annually inspected by Korea FDA If yes, when was the last inspection? 3. Has the facility ever been inspected by the state department of healt/agriculture? If yes, when was the last inspection? 4. Are materials such as penicillin, cephalosporin, agrochemicals, steroids cytotoxics, pesticides, etc. produced at or in proximity to this location? If yes, what precautions are taken to avoid cross-contamination?

Are standards for personal cleanliness listed in written SOPs? 6. Does each employee involved in the manufacture, packaging, testing, and distribution of the materials / products have a written job description? 7. Does each employee involved in the manufacture, packaging, testing and distribution of the materials / products have written records of the training and education received? Is the employee training program in writing?

X X X

Does the training program address GMP training for new employees?

Does the training program address GMP training for veteran employees?

X X

Does the training program address job/task training? Does the training program address SOP and documentation training? Are internal GMP audits conducted at the facility? Facility and Grounds 1. What is the square footage and age of the facility? 2. Are there written SOPs describing the maintenance of the facility grounds? 3. Is the facility designed and constructed to have adequate space for all operations, to assist with the cleaning and maintenance, and to minimize the potential for mixups? 4. Are any of the doors located in the processing areas able to directly access the outside of the facility? 5. Is suitable lighting available in all production and warehouse areas for the task to be performed? 6. Are lighting fixtures equipped with protective covers? 7. Do ventilation and air filtration systems, and temperature / humidity controls exist in areas where it is required to prevent contamination and/or adulteration? 8. Are trash receptacles properly identified and maintained? 9. Are the materials used in the construction of the facilitys floors, walls, ceilings, and work surfaces easy to be cleaned, sanitized, and maintained? 10. Are there written SOPs describing the types of cleaners and sanitizers to be used, with instructions for use and proper storage? 11. Are there written records documenting the cleaning of each processing room / area? 12. Does the facility have a pest control program for the exterior and interior of the facility? 13. Is the individual responsible for the pest control inspections trained and licensed? 14. Are there written records of the pest control inspections? 15. How often to inspection occur? 16. Is potable or better quality water used in the following functions? Cleaning Processing Hand-washing Drinking 17. What is the source of water used in the facility? Municipal Water. X X X X YES NO N/A

X X

X X X X X X X X X X X

18. Are toilet and hand-washing facilities readily accessible to all employees? 19. Do the doors from the toilet facilities open directly into processing areas / rooms? 20. Are all toilet and hand-washing facilities equipped with running water, soap, and towels or hand dryers? 21. Are hand-washing facilities located in each area of the facility where handwashing is required by the employees duties? 22. Are hand-washing facilities equipped with devices or fixtures that prevent recontamination of cleaned hands?

X X X X X X

23. Who is responsible for the overall sanitation program at the facility and what is
his/her title? Sang-Hun An QA Manager 24. Are all equipment cleanable in design and construction and installed in such a manner to facilitate cleaning? 25. Are equipment and utensils cleaned as frequently as necessary using safe cleaning and sanitizing agents? 26. Are non-food handling equipments kept in good state of cleanliness and repair? 27. Are tools and food handling equipments properly stored when not in use? 28. Are conveyors and other food transport systems clean and well-maintained? 29. Is non-food handling equipment kept in good state of cleanliness and repair? 30. Are tools and food handling equipment properly stored when not in use? 31. Are conveyors and other food transport systems clean and well-maintained? 32. Are food-approved cleaning agents and sanitizers being used? 33. Are cleaners and sanitizers stored away from the processing area when not in use? Equipment and Utensils 1. Have precautions been taken to ensure equipment is installed in a manner that assists with cleaning and maintenance?

X X X X X X X X X X YES X NO N/A

2. Is all equipment and utensils that come into contact with the materials /products composed of stainless steel, non-reactive plastics, or some other inert material? 3. If compressed air or gases are used during the processing, is the quality monitored to ensure no moisture or oil is in contact with ingredients? If yes, how often does this monitoring occur?

If processing uses critical process control /measuring equipment,

is the equipment calibrated to ensure accuracy? If yes, how often does this occur? Are there written records documenting the calibration? X

Who is responsible for reviewing the completed calibration records?

Are there written records documenting the use and cleaning of all major pieces of equipment? Who is responsible for reviewing these completed records?

9. Are there written SOPs describing the preventative maintenance activities for all major pieces of equipment? Are there written records documenting the maintenance activities? Who is responsible for reviewing these completed records? Quality Unit Activities 1. Does a quality unit exist at the company? 2. Who is the head of the quality unit at this location and what is his/her title? 3. Is there written SOP describing the responsibilities and authorities of the quality unit? 4. Does the quality unit have the authority to approve /reject the following: a) Procedures. b) Specifications c) Test methods and results d) Raw materials e) Finished products. f) In-process materials. g) Packaging materials. h) Labeling. i) Formulas j) Processing records. k) Forms and documentation.. 5. Does the quality unit have final review and approval for the selection of all suppliers and raw materials? 6. Are the suppliers audited as part of the qualification process? If yes, by company personnel or by a 3rd party? 7. Is supplier compliance to specifications monitored? 8. Does the company have an internal laboratory?

X X

YES X

NO

N/A

X X X X X X X X X X X X X

X X

9. Are contract laboratories used? 10. Is there written SOP describing the selection and approval of contract laboratories? 11. Are there written test methods for analyses performed?

X X X X X X

12. Who provides the test methods? Internally determined

13. Are there written records documenting all testing performed? 14. Are all test methods used, compendial or internally developed, appropriately validated to provide reliable and reproducible results?

15. Is there a written SOP describing how test methods are validated? 16. Is there a written SOP describing the performance of stability studies for existing and new products? 17. Is there a written SOP describing the preparation, review and approval of stability study protocols? 18. Do all products have stability data to support the assigned expiration dating? If not, explain how expiration dates are assigned.

X X

19. Under what conditions are stability studies performed?

20. What regulatory guidelines are followed in the perfomance of stability studies?

21. What occurs if a failure happens during a stability study?

Product Retrieval:

YES

NO

N/A

1. Are there written procedures for: An effective monitoring and retrieval system for food and feed products produced, packaged, or distributed, including...? A defined retrieval team with identified back-ups? the routine monitoring of customer complaints?

X X

maintaining documentation of lot coding on all raw materials, processing aids/ingredients, production batches, and final products? maintaining shipping records capable of locating all product within 6 hours? maintaining a current list of all customers with names, 24-hour phone numbers, fax numbers and their back-ups Practicing a retrieval annually? 2. Are there adequate retain samples to conduct thorough analytical investigations in the case of product retrievals?

Purchasing:

YES

NO

N/A

Are there written procedures for:

Ensuring safe purchasing of raw materials, processing aids, ingredients, and packaging materials, including..? written specifications for all raw materials, processing aids, ingredients, and direct contact packaging materials? documentation of suppliers' agreement to all requirements? The receipt, identification, examination, handling, sampling, testing, and approval/rejection of all raw materials, processing aids, ingredients? The inspection of all raw material, processing aid, ingredient containers upon receipt? The inspection of all raw materials, processing aids, ingredients for extraneous matter (filth, insect), microbiological contamination, and aflotoxins or other toxins, as appropriate? Ensuring that each lot of raw materials, processing aids, ingredients, and packaging materials is identified with a unique lot number, given a status (e.g. quarantined, approved, rejected) and properly released for use? The identification and control of rejected raw materials, processing aids, ingredients, and packaging materials?
MANUFACTURING 1. Are there written SOPs describing the receipt, identification, examination, handling, sampling, testing, review /approval, and storage of raw materials? 2. Are raw material containers inspected at time of receipt? 3. Are the raw material containers identified according to status quarantined / released? 4. Are raw materials examined for possible filth, insects, microbial contamination, or other possible adulterants? If yes, is the examination recorded? YES NO N/A

5. Who is responsible for reviewing these records? Where are these records maintained?

6. Is the Certificate of analysis accepted in place of testing? If yes, what testing is not performed? 7. Are raw materials rotated according to the FIFO (first in, first out) and FEFO (first expiration date, first out)? 8. Are raw materials that have been stored for an extended time re-tested? If yes, what is the re-test interval? If yes, what testing is performed? 9. Are rejected raw materials properly controlled and identified to avoid possible mixups with released materials? 10. Are raw materials, in-process materials, and finished products segregated during processing and/or storage to avoid potential mix-ups? 11. Is there a master production record for each finished product produced? 12. Do these master production records include the following: a) Raw material name b) List and amounts of all materials to be used in processing c) Processing instructions d) Total theoretical amount of processed product to be obtained e) Acceptable yield limits f) Description of the finished product packaging and labeling 13. Is there a processing record generated for each batch of product to be processed? If yes, who is responsible for issuing this record? 14. Are there written specifications for finished products? 15. Is there a written SOP for reprocessing of any products? 16. Is the finished product identified with a lot number allowing traceability of the history of the batch and its processing? 17. Are finished product containers inspected for correct lot number and label prior to distribution? 18. Are retained samples kept for all raw materials and finished products? If yes, how long are they retained? 19. Is there a written SOP describing the final review and approval of finished products for release prior to distribution? 20. Who is responsible for performing this release?

21. Is there a written SOP describing how processing changes are reviewed, approved, and implemented?

22. Is there a written SOP describing the handling of customer complaints?

23. Are there written records documenting the customer complaints and investigations? 24. Who is responsible for reviewing these records? Where are these records maintained? 25. Is there a written SOP describing the handling of product recalls? 26. Are the records relating to the receipt, sampling, testing, processing and distribution of products retained for at least 1 year beyond the expiration date of the product? 27. If the product does not have an expiration date, are these records maintained at least 3 years after processing? Warehousing and Distribution 1. Are finished products stored in the warehouse identified according to status quarantined / released? 2. Are there written records documenting the distribution of finished products? 3. Do you use tamper evident seals or locking devices on finished products being transporter? 4. Where are these records maintained? 5. Do these records include the following information? a) Order and ship date b) Customer name and address c) Product lot numbers and package sizes.. d) Identification of personnel who filled the shipping order e) Identification of the carrier used to transport the product.. 6. Is there a written SOP describing the identification, handling, examination and disposition of returned products? 7. Are there written records documenting the receipt, handling, examination, and disposition of returned products? 8. Who is responsible for reviewing these records? Where are these records maintained? 9. Are finished products distributed in a FPFO (first processed, first out) and/or FEFO (first expiration date, first out) manner? YES NO N/A

10. Is the warehouse clean and well-maintained? 11. Are proper precautions taken to ensure transport carriers do not adversely affect the condition of the ingredients? 12. What precautions are taken?

X X

Computer Systems 1. Are computer systems used for GMP required systems or documentation? If yes, what functions does the computer systems control / manage? 2. Has the computer hardware and software been validated? 3. Are paper records maintained of the data input into the computer system? Which are considered the primary records? 4. Is there a written SOP describing the operations of the computer system?

YES

NO

N/A

5. Is there a written SOP describing the safety and security measures of the computer system? 6. Does the computer system adhere to Part 11 requirements for electronic records? 7. Are routine back-ups performed to prevent accidental loss of data? How often do the back-ups occur? Validation Activities 1. Does the company have a master validation plan? 2. Is there a written SOP describing the preparation, review, approval and issuance of validation protocols? 3. Has facility systems qualifications been performed? 4. Has equipment IQ, OQ, and PQ validations been performed? If yes, which pieces of equipment have been validated? 5. Has process validation been performed for all products produced? 6. Has cleaning validation been performed? If yes, what cleaning procedures have been validated? YES NO N/A

7. What items are tested for in the cleaning validation? 8. Have all test methods used been validated?

9. Is there a written SOP describing when re-validation must occur?

Product Security: Are there written procedures for: Product security programs? transportation (seals, inspections, etc.)? securing critical areas of production and distribution, including final product storage, raw material/packaging storage areas, warehouses, 3rd party facilities? control programs for the receipt of all raw materials, processing aids, ingredients, and direct contact packaging materials? Lot coding (to track material flow into finished products)? product retrieval systems? Air: are there written procedures for: Air quality, including..? ...having air compressors, UV air filters, critical air handling systems in PM program ...filters on all air compressors ...positive pressure environments where product is exposed to the plant environment ...food grade lubricants on compressors where air compressed air is expected to contact finished product ...point of use filters where compressed air enters product contact areas Product Retrieval: Are there written procedures for: An effective monitoring and retrieval system for food and feed products produced, packaged? Allergen Control Includes: milk and milk derivatives egg and egg derivatives peanuts (groundnuts) Tree-nuts Soy and soy derivatives Wheat and wheat derivatives Fin fish and fish derivatives Shellfish including crustaceans Are there written procedures for: Reducing the risk of incidental co-mingling of allergens, including...? ...separate storage of allergenic vs. non-allergenic raw materials, ingredients, and processing aids. dedication of utensils used only for allergenic raw materials, ingredients, and processing aids? cleaning of equipment used for both allergenic and non-allergenic processing? Properly identifying allergens for the purpose of labeling? Lot Coding and Product Labeling: Are there written procedures for: Ensuring proper traceability and labeling of finished products, including ...lot coding on individual packages or containers? lot coding on Bill of Ladings for bulk shipments? ...a lot code that identifies date, location of manufacture? legend to interpret lot, batch codes? legibility of batch, lot codes? compliance with pertinent regulations? The documentation of batch, lot numbers for all processing aids, ingredients, and direct packaging materials identified into the production process? The receipt, examination, and storage of incoming labels and labeling materials? The receipt, examination, and storage of packaging materials? Ensuring the correct labels and packaging materials are used? A final examination of packaged, labeled product for correct label and lot number? Handling unlabeled, packaged finished product?

YES

NO

N/A

YES

NO

N/A

YES

NO

N/A

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Name and Title of person completing this form:

____________________________________________ Name / Title

_____________________________________________ Signature:

__________________________ Date

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