GENERAL GUIDELINES A. Organization (Organization, Qualification, Responsibilities and Tranings) GMP AUDIT CHECKLIST YON N/A Remarks 1. 1s there an existing Organizational structure within the Plant that concerns the GMP regulations? [2. Are the function of Production and Quality Assurance separated by authority which neither of whom report | to the other? [3. Are personnel in each department are adequately trained to perform their function effectively? /4. Does the quality and production personnel conforms Pot Desc pbow othe responsibilities set by the cGMP regulations? | 5. Are records of training regarding the GMP imaintained? Is the performance tracked? B. Premises (Grounds, Plant Construction and Design) YON N/A Remarks i. Are grounds contructed and maintained to protect, against weather, flood, ground seepage, and the access land harboring of vermin, rodents, birds, Insects or lother ani als? 2. Does the Plant includes activity that would control pest, dirt and filth that may be a source of food |contamination? 3. Is there a housekeeping practices that would properly store equipment, remove liter and waste, and cutting weeds or grass within the immediate vicinity of is or structures that may constitute an attractant, breeding place or harborage for pest? the plant buil 4. is there a provision and proper systems on waste {treatment and disposal in conformance with DENR. regulation on waste disposal and treatment? IS. Does the system for waste disposal and treatment designed and constructed in an appropriate manner so that they do not constitute a source of contamination lof areas where food is exposed? 6. Is the plant, buildings and structures facilitates Imaintenance and sanitary operations for food manufacturing purposes adequate so that no risk of, cross contamination will affect the safety of food manufactured?71s there a Master Plan diagram that shows the following: a. building outline with production areas, service areas jand surroundings [b. access for personnel and traffic ways - for incoming land outgoing raw material [c. rivers, cannals and other water catchment areas 6, swamps/marshes [d. any approximate potential origins of problem - eg. housing, industries, etc. le. waste collection areas [f. prevailing wind direction |g: definition of main areas - in terms of hygiene zones ih. planned cleaning practices - by area i. circulation of people and vehicles - flow of goods including raw materials, packaging, intermediate roducts j. waste utilities - including the waste water treatment plant 8. Is there a sufficient space for placement and loperations of equipment, and storage of materials as is necessary for the maintenance of sanitary operations land the production of safe food? 9. Is there an adequate food safety controls through effective design and construction including the separation of operations in which food contamination is likely to occur? /10. Are the following requirements for plant construction met: fa Floors where appropriate, shall be of waterproof, non-absorbent, washable, and non-slip material, lwithout crevices, and shall be easy to clean and disinfect. Floors shall slope sufficiently for liquids to |drain to trapped outlets. b. Walls were appropriate, shall be of waterproof, non- absorbent and washable materials sealed and free of sects and shall be light colored. Walls shall be smooth land without crevices and shall be easily clean and. disinfect. Jc. Angles between walls, between walls and floors, and between walls and ceiling in food handling areas shall be sealed and coved to facilitate cleaning. [a Ceiling is designed, constructed and finished as to prevent the acccumulation of dirt and minimize condensation, mold development and flaking and shall be easy to clean.fe. Windows and other openings shall be constructed as to avoid accumulation of dirt and those which open. shall be fitted with insect-proof screens. Screens shall be easily movable for cleaning and kept in good repair. Ff. Internal windowsills, shall be sloped to prevent use as. shelves. lg Door shall have smooth, non-absorbent surfaces and, lwhere appropriate, be self-closing and close fitting. [h. drains shall be of adequate sized with traps I. Stars, lft cages and auniliary structures such as platforms, ladders, chutes, shall be so situated and |construted as not to cause contamination to food. (Chutes shall be constructed with inspection and cleaning hatches. [11 Is the processing of materials for food products |separated from the production of non-food products? 2. 1s there a separate for cleaning mobile equipment Jand storage of cleaning materials? 113. Is there a provision of locker/gowning room directly connected but separated from processing areas? 114. Is the toilet facilities not directly opened to production? 115. Does the toilet water and ventilation? fes with adequate supply oF 116. Is there a defined areas for the following loperations? fa. gowning / change rooms for all personnel [b. receiving of starting materials. [incoming goods quarantine [d: sampling room for sampling deliveries of starting. materials le. storage for approved materials (chemical and packaging) f. storage of reject materials lg. Quality Control facilities, [h. Preparation of materials I. Processing Operations Equipment washing k. Storage of cleaned, idle / non-functional equipment I major repair and maintenance activities im. storage of cleaning tools and supplies [n. staging / storage of bulk products o. packaging / labeling operations [p- Quarantine storage for finished productsa. storage / warehouse for approved finished products F.canteen 117. 1s there an adequate natural or artificial lighting provided throughout the establishment? /18. Are shatter proof equipment installed protected lagainst food contamination in case of glass breakage? 19. Is there an adequate ventilation provided to prevent excessive build up of heat, dust odors and [vapors (including steam and noxious fumes) in areas lwhere they may contaminate food? 20. Are the fans and other air-blowing equipment located in a manner that minimizes the potential for contaminating food, food-packaging materials, and |food-contact surfaces, ie. the direction of the air flow within the plant shall never be from a dirty area to clean area [22. Are the ventilation openings were provided by the |screens or other protecting enclosure of non-corrodible material, and be easily removed for cleaning? 22. Are the screen provides protection against pests? C. Equipment N/A Remarks [1 Are the equipment and utensils directly utilized for {food manufacturing designed and constructed using |material that is easily and adequately cleanable and Imaintained? 2. Are the equipment corrosion resistant? [3. Are the equipment made of non-toxic materials and [designed to withstand the environment of intended. use? [4. Are the seams of equipment smoothly bonded and maintained to minimze accumulation of food particles? /5. Are the equipment installed and located suitable to eliminate cross-contamination and facilitate the [cleaning and its adjacent spaces? 6. Is the holding, conveying and manufacturing systems including gravimetric, pneumatic, closed and lautomated systems designed and constructed to enable lto maintain in appropriate sanitary condition. 17. Are the other equipment in the processing area that |does not come in contact with the food constructed in [a manner that facilitate their cleaning and maintenance?8. Does the freezer and other cold storage equipment, incubators and other controlled environment lequipment fitted with proper measuring devices for regulating the control parameters such as tempratures? [9 Are the instrument for regulations of control calibrated and maintained in good condition? 110. Are record of calibration kept and maintained? [ia Are the clean and sanitized portable equipment and utensils with product-contact surfaces stored in a manner that product-contact surfaces are protected from splash, dust and other contamination? 112. Are the equipment installed with shatter proof for glass parts? 23, Are the equipment not lacquered nor painted? [14. Are the equipment do not have hollow bodies |where there is a chance of product contact? 115. Are all equipment allow for sampling and measuring| of product quality? D. Sanitation and Hygiene (Personnel, Education and ‘Traininga and Supervision) NA Remarks 1. Has the Management defines its policy and document its procedures on sanitation and personnel hygiene and take all reasonable measures and [precautions to ensure Disease Control and Hygienic Practices? 2. 1s there a personnel who, by medical examination or supervisory observation, is shown to have, or appears to have possible source of microbial contamination be lexcluded from any food handling / contact operations luntit condition is corrected? [3 Is there an established / documented procedures for |disease control including specific instruction for all personnel to report such health conditions to their lsupervisors?, as there an established / documented procedures and lwork instructions made known to all appropriate [personnel for maintaining cleanliness to include but are not limited to: fa, Wearing outer garments including working shoes suitable to the operation in a manner that protects against the contamination of food, food-contact. jsurfaces, or food-packaging materials. [b. Maintaining adequate personal cleanliness.[c. Washing hands thoroughly (sanitizing if necessary to protect against contamination with undesirable microorganism) in an adequate handwashing facility before starting to work, after each absence from the lwork station, and at any other time when the hands may have become soiled or contaminated jd. Removing all unsecured jewelry and othe objects that might fall into food, equipment, or containers and removing hand jewelry that cannot be adequately sanitized during periods in which foods is manipulated by hands. le. For hand jewelry that cannot be removed, it shall be |covered by material which can be maintained in an intact, clean and sanitary condition and which effectively protects against food contamination by these objects. [f- Maintaining gloves, if they are used in food handling, an intact, clean, and sanitary condition. The gloves should be of an impermeable material. [g: Wearing, where appropriate, in an effective manner hairnets, headbands, caps, beard covers, or other effective hair restraints. h. Storing clothing or other personal belongings in areas, other than where food is exposed or, where Jequipment or utensils are washed, i. Confining the following to areas other than where {food may be exposed or where equipment or utensils fare washed: eating food, chewing gum, drinking beverages, or using tobacco. [- Taking any other necessary precautions to protect Jagainst contamination of food, food-contact surfaces, lor food-packaging materials with microorganisms or |foreign substances including but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and Imedicines applied to the st 51s there a training program established and maintained to define appropriate training necessary for {food handlers and supervisors on proper food handling |techniques and food-protection principles? 6. Is the training regularly instituted and validated to lensure compliance of personnel to established procedures and work instructions?7-1 there an authorized personnel for assuring compliance to established procedures and work instructions and identifying sanitation failures or food contamination by all personne!? 8. Is the authorized personnel responsible for |identifying sanitation failures or food contamination |problems have an educational backgorund or lexperience, or a combination thereof, with a level of competency necessary for production of clean and safe food? E, Sanitary Facilities N/A Remarks 1. Is the water supply quality necessary for the product, process or use? 2. 1s the potable water can be used as a product ingredient, for cooling and heating, and in this case, it shall be of potable quality? 3. 1s there an ample supply of potable water under ladequate pressure and suitable temperature available with adequate facilitiesfor its storage, where necessary, land distribution? 4. 1s the potable water with adequate protection jagainst contamination of stored water? 5. 1s the non-potable water in the plant, €¢. for fire control, refrigeration and other similar purposes, not lused in food manufacture was identifed cicuits separated from potable water? 6. 1s there a facility that has an efficient effluent and waste disposal system and facilities for storage of waste| {and inedible materilas, which should at all times be /maintained in good order and repair and in conformance with DENR regulations? 7. Are the effluent lines (including sewer systems) large lenough to carry peak loads and constructed to avoid contamination of potable water supplies? 8. Is there a provision of adequate changing facilities? 9.1 there an adequate number of tollets in all establishments? 10. Is the toilet facility designed and constructed to lensure hygienic removal of waste matter? 114. Are hand-washing stations located in a passageway towards the processing areas? 112. Are hand-washing facilities with sufficient supply of potable water, hand cleaning preparation and with suitable hygienic means of drying hands? 13. Is there a facilities for hand disinfection?[14 Is the water used for handwashing potable? 115. Is there a suitable hygienic means of drying hands? 116, Is there a sufficient number of dispensers or receptacles provided adjacent to each washing facility if| jpaper towels are used? 117. Is there an optional taps of a non-hand operable type installed? 18. Is the facilities furnished with properly trapped lwastewater pipes leading to drains? 119. Where appropriate, is there a facilities for cleaning land disinfection of working implements and equipment Imade of corrosion resistant materials, capable of being easily cleaned with suitable means of supplying potable lwater in sufficient quantities? 20. Is there a Storage of waste and inedible mater prior to removal from the processing plant designed to prevent access by pests and possible contamination of |food, potable water, equipment, building or roadways lon the premises? [24. Has the plant prohibits the consumption of food in processing areas, warehouses and offices inside the production areas and in the laboratories unless lotherwise provided with pantry? [22. Is hygienic conditions and practices maintain in the leating facilities? F. Maintenance and Sanitation N/A Remarks 1. Is there a procedure for general maintenance of the plant and its premises? 2, Are all establishments and equipment maintained to facilitate proper sanitation procedures? 3. Are all establishments and equipment maintained to function as intended? |4. Are all establishments and equipment maintained to prevent contamination, e.g. from metal shards, flaking plasters, debris and chemicals? IS. Is there a procedure on removing food residues and dirt, which may be a source of contamination? 6. Is there a cleaning method and materials used? 71s disinfection done after cleaning?fa. Is there a procedure for cleaning and maintaining sanitary conditions of buildings, fixtures and other physical facilities of the plant to avold the danger of |contamination of food and food-contact surfaces? 9, Are the detergents, sanitizers and other supplies lemployed in cleaning and sanitizing procedures safe land effective for thelr intended uses? 110. Are toxic materials used in laboratory, equipment maintenance and operation, and manufacturing or processing operations identified and used under |conditions that ensures their safe use? IIL. Are the cleaning chemicals, detergents and sanitizers handled in accordance to manufacturer's instruction, and are separated from food to avoid the risk of contaminating food? 112. Are food and equipment protected from the |cleaning agents during maintenance? 113. Are cleaning agents used are of food grade? [14 Are plant maintenance personnel trained on specific maintenance procedures on quality and hygiene before allowing them to work during Plant maintenance? 115. Is there an existing Cleaning procedures and methods for each process? And How? 116. Does the cleaning procedure includes the following, lwhere appropriate? fa. Removing gross debris from surfaces. lb. Applying a detergent solution to loosen soil and bacterial film and hold them in solution or suspension. [Rinsing with water to remove loosened soll and residues of detergents. id. Dry cleaning or other appropriate methods for removing and collection residues and debris. je. where necessary, disinfections with subsequent rinsing unless the manufacturer's instructions indicate lon scientific basis that rinsing are not required. 27. 1s there a cleaning program in place? 118. Does the program includes cleaning of cleaning Jequipment? '19. Does the program includes all parts of establishments? 20. Are the following item in the cleaning programs included:fa. Areas, items of equipment and utensils to be cleaned; [b. responsibility for particular tasks; [c. Method and frequency of cleaning: [d. Monitoring arrangements. 21. Was the program consulted with relevant specialist lexpert advisors? 22. 1s there a procedure for controlling animal and lvermin? 23. Is there a control for animals or birds in any area in |those essential as raw materials of a food plant? 2. is there a measure taken to exclude pests from the processing areaa and to protect against the [contamination of foods on the premises by animals, birds, and vermin (including but not limited to, rodent land insects)? 25. Is there a control of insecticides or rodenticides lusage to prevent the contamination of food, food contact surfaces or packaging materials with toxic and hazardous residue? 26. Is there a Pest Control Activity in the plant? 27. Are buildings kept in good repair to prevent pest access and to eliminate breeding sites? [28. Are holes, drains, and other places where pest are likely to gain access kept sealed? 29. 1s there a presence of animals on grounds of factories? 30. Is there a presence of potential food sources for pest in the area? 31. Is the area both inside and outside food premises kept clean? 32. Are refuse stored in covered, pest proof containers: [33. Is the area regularly examined for evidence of infestation? [34. Is there a treatment with chemical, physical or biological agents carried out without posing a threat to [the safety and suitability of food? G. Production and Process Controls (Production Processes and Controls, Manufacturing Operations) N/A Remarks i. Is there a Sanitation Guidelines in receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and stoing of food? 2. 1s there a quality control procedure to ensure that lfood is suitable for human consumption? 3. Is the food- packaging materials used are safe and suitable for human consumption?[4. Are production processes do not contribute contamination from any source? 5. Is there a procedure for contar iated products? 6. 1s there a rework process? 7. 1s there a control for each line which could affect consumer safety or satisfaction to prevent problems? 8. Is there a hazard and root cause analyses used to specifically control measure for Critical Control Points (CPs) for food safety and Controt Points (CPs) for consistency? 9. 1s there a sanitary procedures and work instructions lon handling raw materials and ingredients? [10. Are the raw materials being inspected and either segregated or otherwise properly handled to ascertain that they are clean and suitable for processing ir food? 111. Are raw materials and ingredients stored under [conditions that will protect against contamination and minimize deterioration? 112. Are tranporters containers of raw materials and ingredients inspected on receipt to ensure that thelr |condition has not contributed to the contamination or deterioration of food? 113. Are raw materials and ingredients does not contain levels of microorganisms that may produce food poisoning or other disease in humans? 114, is there a subsequent treatment during manufacturing operations so that they no longer [contain levels that would cause the product to be adulterated? 5. [s there a suppliers guarantee or certificate to lensure that raw materials and ingredients are safe? 116. For rework items, is there a procedure to ensure its safety for human consumption? 117. Are the rework items being scheduled and identified? [18. Are there any frozen raw materials used? 19. Is there a procedure and work instruction lestablished for the sanitary handling and maintenance lof equipment and utensils for manufacturing loperations? 20. 1s there a maintenance of equipment an utensils land finished food containers in a sanitary condition Ithrough appropriate cleaning and sanitizing?21. Is there a monitoring of physical factors and |manufacturing operation to ensure that mechanical breakdowns, time delays, temperature fluctuation, and luncontrolled events do not contribute to the |decomposition or contamination of food. [22. 1s there a procedure for specific manner for food {that can support the rapid growth of undesirable microorganisms, particularly those of public health significance to prevent the food from becoming |contaminated? 23. Are work-in-process handled in a manner that, protects against contamination? 124, Is there a separation of handling finished food from raw materials, other ingrdients, or refuse in a receving, loading, or shipping area that could result in |contaminated food? [25. Are there sieves, traps, magnets, electronic metal |detectors, and other sultable means to protect against the inclusion of metal or other extraneous material in lfood? 26. 1s there a procedure on how to deal with broken lglass in food? 27. Is there a procedure on handling adulterated / contaminated food, raw materials, and other ingredients that protect against the contamination of lother food? 28. Is there a established method proven to be effective| {or adulterated / contaminated food as reconditioned? 29. 1s there a test done before being incorporated into jother food? 30. Is the monitoring done for mainataining moisture level that relies on the control of preventing lundesirable microorganism? 31. Is there a monitoring of processes that are taken to destroy or prevent the growth of undesirable Imicroorganisms, particularly those of public health significance, under the conditions of manufactur, handling, and distribution to prevent food from being |contaminated within the meaning of the act? 32, Is there amonitoring done for physical protection of |food from contaminants that may drip, drain, or be |drawn into the food operations like washing, peeling, {trimming to protect food against contamination?33. Is there a monitoring procedure using time and ltemperature controls at and between each manufacturing step by cleaning and sanitizing food contact surfaces? 34. Is there a procedure in monitoring thermophilic growth and contamination in blanchers through periodic cleaning? 35. Is there a procedure for protecting food against, |conatmination on the preparation of batters, sauces, breading, gravies, dressings and other similar preparations? 36. Is there a procedure on protecting food against |contamination through filling, assembling, packaging, repacking and other operations? 37. 1s the pH monitored and maintained at 4.6 or below for food such as, but not limited to, acid and acidified |food for preventing the growth of undesirable microorganisms? 38. Is the ice used in contact with food made from potable water and itis manufactured, stored and handled in accordance with good manufacturing practices? 39. is the steam used in contact with food of food grade| quality? 40. Is make up water potable and comply with current {food legislation standards? [41. Are steam pipe insulation sealed in a manner that it |does become hiding place for insects? 42. 1s the food manufacturing areas and equipment, lused for nonhuman food food grade animal feed or inedible products? [43. Is there no possibility for the contamination of the human food? [44. Are allergens control in a manner where no possibilities of contamination to other food that do not, normally contain these allergens and that do not normally carry a specific mention in the ingredient statement? H. Quality Control (Quality Management, Testing of Reprocessed Products and Returned Goods, Laboratory Facilities and Controls) N/A Remarks i. is there an established quality control system to lensure that products contain the correct materials of specified quality and quantity and are manufactured lunder proper conditions following standard procedures to ensure quality and safety of the product?[21s the quality control involves sampling, inspecting, land testing of starting materials, in process, intermediate, bulk and finished products? 3. 1s the quality control includes where applicable, review of batch documentation, sample retention program, stability studies, product complaints, product recalls, and maintaining correct specifications of. materials and products? 4. is the method of testing of reprocessed products levaluated to ensure that they do not affect the quality lof the product? 5. 1s there an additional testing performed of finished product, which has been reprocessed? 6. Is there an established procedure for testing done for returned goods? 7. Are returned products identified, stored separately either in allocated area or by movaeble barrier such as, rope or tape? [8. Are returned products testing if necessary, in laddition to physical evaluation before being released lfor distribution? 9. Is there a procedure that any returned products that, Jd not comply with the original specification should be rejected? 10. Are rejected products disposed according to appropriate procedures? 111. Is there a record mainained for returned products? 1.2. Is the laboratory well desgned to suit the relevant loperations? 13. Is the laboratory separated physically from the Iproduction areas? 114. Are the concomitant facilities such as laboratory lequipment and instrument suitable to the testing procedures undertaken? |. Documentaion N/A Remarks 1 Are all documents related to the manufacture and loperations from raw materials, packaging materials, master production and control, batch production, laboratory control and batch production record review reviewed, approved and distributed according to writte spocedures? 2. Are documents controlled by maintianing revision histories that were issued, revised, superseded and withdrawn?3. 1s there an established procedure for retaining all appropriate documents (e.g. development history reports, scale-up reports, technical transfer reports, process vaalidation reports, training records, production records, control records, and distribution records)? Id. Is there a specific retention time for each records? 5. Does the record of major equipment use, cleaning, sanitation, and/or sterilization and maintenance shows the date, time, (if appropriate), product, and batch number of each batch processed in the equipment and the person who performed the cleaning and maintenance? 6. Is the a docuemnted and established specifications for raw materials, labelling and packaging materials? 17.1 there a documented and established acceptance [critieris for in-process controls? 4. Audits: N/A Remarks 1. Is there an existing quality audit which consists of an lexamination and assessment of all or part of a quality system with the specific purpose of improving it? 2. Is the quality audit conducted by outside or independent specialists or an internal audit team |designated by the management team? 3. Are the audits extended to suppliers and contractors? [a Is the audit made with reports after completion? K Warehousing and Distribution NAY Remarks 1. Is there a procedure for sanitary handling of food on [storage and distribution? 2. Is the storage and transportation of finished food lunder the conditions that will protect food against physical, chemical, and microbial contamination as well {as deterioration of the food and the container? 3 Is the warehouse kept free from rodents, insects, birds and other pests? [4. Are product spills cleaned up immediately to prevent harborage of pests? 5. Are there pesticides, disinfectants, toxic chemicals or lother contaminating materials must be stored in close proximity to finished products or incomng products?6. Is the in plant storage organized to ensure that, potentially contaminated incoming materials are not stored next to finished products? 7. Are defective stocks, market returns or complaint |goods stored in a separate area and locked? a. Is the storage facilities secure enough to prevent theft, tampering etc.? [9s the FIFO system and a stock control syster palce? 110. i the area kept clean and tidy-noy only inside but also in the surrounding areas? L Product Recall N/A Remarks 1. Are all quality related complaints, whether received lorally or in writing, recorded and investigated according | jto.a written procedure? 2, Are documented records of complaint retained to levaluate trends, product related frequencies and severity with a view to taking additional and if lappropriate, immediate corrective action? 3. Is the a written procedure that defines the circumstances under which a recall should be Iconsidered? 4. In the recall procedure, is there a designated person lwho should be involved in evaluating the information? 5. Is there a procedure on how recall is initiated? 6. Is there a procedure on whom should be informed labout the recall? 7. Is there a procedure on how the recalled material should be treated? [8. Arethe local and national authorities informed and their advice sought in the event of a serious or potentially life threatening situation? 9. Is there a procedure for the communication of international authority come from the national lauthorities and not from the local companies? 110. Is there a traceability record of raw materials, packaging materials, processing data and laboratory results which could be relevant to analyze the effectiveness of the implementation of procedure for product recall? M. Retention Samples N/A Remarks 1. Is the a retention sample system?2. 1s the retention sample adequate of samples of the finished batch product from the production / packaging line to serves as reserve or retention samples? 3.15 the number of sample adequate for complete testing, if when necessary to do? 4. Are the retention samples stored in an area |compatible with storage condition prevailing in the market? IN. Sub-Contracting of Manufacture NA Remarks 1. 1s the plant engage in a sub-contract manufacturing? 2. 1s the conditions of contract manufacturing defines, agrees and controls so as to avoid misunderstandings which could result in a product or work of unacceptable| quality? 3. Are all aspects of contracted work specifies to obtain! a quality product conforming to agreed standards? [4-1 the a written contract between the principal and the contract manufacturer to clearly establish the [duties and responsibilities?