Vivat Keawdounglek (Ph.D.) Learning material of 1807307 (Food Sanitation and Safety) Part 10 to 11: Principle of Food Sanitation Laboratory Conclusion for chemical contamination on food ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… References Cappuccino, J.G. & Sherman, N. (2008). Microbiology: a laboratory manual. 9th ed. San Francisco: Benjamin Cummins. Dreamtime. (2000). Escherichia coli bacteria E. coli. Medically accurate 3D illustration, labeled. Infection, flagellum. Retrieved on February 12, 2016 from https://www.dreamstime.com/escherichia-coli-bacteria-e-coli-medically- accurate-d-illustration-labeled-illustration-showing-escherichia-coli-bacteria- e-coli-image151515456 G & A Warburtons Ltd. (2016). Borax. Retrieved on February 18, 2019 from https://www.warburtons.co.nz/shop/Shop+by+Category/Tools+%26+Supplies/ Soldering/BORAX+POWDER.html Hale Cosmeceuticals Inc. (2009). Chemical Peels. Retrieved on February 18, 2019 from https://www.halecosmeceuticals.com/peels/ Indian chemical company. (n.d.). Sodium Hydrosulfite. Retrieved on February 18, 2019 from https://www.exportersindia.com/indian-chemical-company/sodium- hydrosulfite-3089679.htm Indiantmart. (2019). Laboratory Reagent Formalin. Retrieved on February 18, 2019 from https://www.indiamart.com/proddetail/laboratory-reagent-formalin- 19674467488.html Microbe Online. (2019). EMB Agar: Composition, uses and colony characteristics. Retrieved on February 18, 2019 from https://microbeonline.com/eosin- methylene-blue-emb-agar-composition-uses-colony-characteristics/ Soleris. (2018). Coliform Vial-9 mL. Retrieved on February 18, 2019 from https://foodsafety.neogen.com/pdf/prodinfo/cc-109_ts_en-us_soleris.pdf Spilatro, S.R. (2004). Lactose Broth Results. Retrieved on February 12, 2016 from http://w3.marietta.edu/~spilatrs/biol202/labresults/lactose_broth.html U.S. Food and Drug Administration. (2015). Bacteriological Analytical Manual. Retrieved on March 3, 2016 from http://www.fda.gov/ Food/ FoodScienceResearch/ LaboratoryMethods/ucm2006949.htm Yanasinee Suma. (2015). Laboratory 8: Microbiological analysis of food products. Chiang Rai: Mae Fah Luang University. Page | 143
Vivat Keawdounglek (Ph.D.) Learning material of 1807307 (Food Sanitation and Safety) Part 10 to 11: Principle of Food Sanitation Laboratory วีรานุช หลาง. (2552). ค่มู ือการตรวจวิเคราะห์ดา้ นจุลชีววิทยาทางอาหาร. กรุงเทพมหานคร: มหาวิทยาลัยเกษตรศาสตร์. กรมวิทยาศาสตร์การแพทย์.(2551). ค่มู ือการใชช้ ุดทดสอบอาหาร. กรุงเทพมหานคร: โรงพิมพ์ สานักงานพระพุทธศาสตร์แห่งชาต.ิ Page | 144
Learning Material 1807307 (Food Sanitation and Safety) Part 12: Good Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Point (HACCP) At the end of the session, students must be able to 1. Describe the principle of GMP and HACCP 2. Describe the process of GMP and HACCP 3. Apply the principle of GMP and HACCP in the real situation Food industry or food processing has a complexity of production process. Therefore, the risk for food contamination is higher than a food shop or food restaurant. GMP and HACCP is the process to reduce the risk of food contamination in the food processing. In this part of learning material, the principle of GMP and HACCP are concluded to easily application for the food industry. 12.1 Standard Operating Procedure (SOP) National Food Service Management Institute, The University of Mississippi (2014) state that the Standard Operating Procedure (SOP) is a set of directions that should (must) be followed to ensure food safety when completing certain tasks such as cooking chicken, cooling a food, or sanitizing a work surface. These SOP's should be used as a guide to establishing a food safety program for your operation. There are several direction for SOP including good employee hygiene practices (i.e. handwashing), cross contamination control (i.e. keeping raw products separate from cooked and ready-to-eat foods), and environmental hygiene practice (i.e. effective cleaning and sanitizing of equipment and utensils). Figure 12.1 to 12.2 provide the format and the example of SOP for food establishment. 12.2 Good Manufacturing Practice (GMP) As can be seen in the definition of GMP created by World Health Organization (2015), Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active
Vivat Keawdounglek (Ph.D.) Learning material of 1807307 (Food Sanitation and Safety) Part 12: Good Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Point (HACCP) ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. 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. Table 12.1 is provide the component of food GMP Name of facility………………………………………………………page……..of…………. SOP Number__________________________Title__________________________________ Revision number________________________________ Written by____________________ Edited By__________________________ Authorization signature_________________Department_______________Date__________ Effective date_________________________Replaces______________________________ Purpose: WHY Why is this procedure written? Why is it being performed? Scope WHEN: Indicate when this procedure needs to be performed. WHERE: Indicate where this procedure applies. Responsibility WHO: Who performs the procedure, who is responsible to see it is performed correctly. Materials and equipment WHAT: What is needed to perform the test. The list should be complete and specific. Procedure HOW: Clear concise, step by step instructions on how to perform the procedure. This should be written as instructions for the operator to follow, without a lot of theoretical background. A section on fundamental principles can be included if necessary. It should include: a) Preliminary steps that must be done before beginning the actual procedure. b) Safety considerations: Precautions for work with physical, chemical, or biological hazards (containment facility clothing, masks, hoods, goggles, gloves, cleanup of spills etc.). c) The chronological instructions. It is useful to number the steps so that repeat steps can be referred to rather than making the SOP very long. d) Calculations: Explanations and sample of how to do any required calculations. Reporting WHAT NEXT: a) Indicate where the results should be recorded. b) Explain what to do if there are problems during the test. c) Indicate that deviations to the procedure must be approved and recorded. d) Identify the person to whom the final results should be reported. Reference documents: List other SOPs which directly affect or are relevant to this procedure. For example, the SOP for making a buffer used in the procedure, or the SOP for the operation of a piece of equipment used in the procedure. Figure 12.1 Format for a standard operating procedure (SOP) Source: World Health Organization, 1997, pp. 15-16. Page | 146
Vivat Keawdounglek (Ph.D.) Learning material of 1807307 (Food Sanitation and Safety) Part 12: Good Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Point (HACCP) Cleaning and Sanitizing Food Contact Surfaces (Sample SOP) PURPOSE: To prevent foodborne illness by ensuring that all food contact surfaces are properly cleaned and sanitized. SCOPE: This procedure applies to foodservice employees involved in cleaning and sanitizing food contact surfaces. KEY WORDS: Food Contact Surface, Cleaning, Sanitizing INSTRUCTIONS: 1. Train foodservice employees on using the procedures in this SOP. 2. Follow State or local health department requirements. 3. Follow manufacturer’s instructions regarding the use and maintenance of equipment and use of chemicals for cleaning and sanitizing food contact surfaces. Refer to Storing and Using Poisonous or Toxic Chemicals SOP. 4. If State or local requirements are based on the 2001 FDA Food Code, wash, rinse, and sanitize food contact surfaces of sinks, tables, equipment, utensils, thermometers, carts, and equipment: Before each use Between uses when preparing different types of raw animal foods, such as eggs, fish, meat, and poultry Between uses when preparing ready-to-eat foods and raw animal foods, such as eggs, fish, meat, and poultry Any time contamination occurs or is suspected 5. Wash, rinse, and sanitize food contact surfaces of sinks, tables, equipment, utensils, thermometers, carts, and equipment using the following procedure: Wash surface with detergent solution. Rinse surface with clean water. Sanitize surface using a sanitizing solution mixed at a concentration specified on the manufacturer’s label. Place wet items in a manner to allow air drying. Figure 12.2 Example of a standard operating procedure (SOP) Source: National Food Service Management Institute, The University of Mississippi, 2014. Page | 147
Vivat Keawdounglek (Ph.D.) Learning material of 1807307 (Food Sanitation and Safety) Part 12: Good Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Point (HACCP) Table 12.1 The component of food GMP Component of food GMP Detail Key Provisions Personnel o -Disease control o -Cleanliness o -Education and training, supervision Plants and grounds o -Grounds o -Plant design and construction Sanitary operations o -General maintenance o -Substances used for cleaning o -Pest control o -Sanitation of food-contact surfaces o -Storage and handling. Sanitary facilities and controls o -Water supply o -Plumbing o -Sewage disposal o -Toilet facilities o -Hand-washing facilities o -Rubbish and offal disposal Equipment and utensils Processes and controls o -Raw materials o -Manufacturing operations Warehousing & distribution Training Appropriate training for food handlers and supervisors in proper food handling techniques and food protection principles. Training should ensure awareness of the dangers of poor personal hygiene and insanitary practices. Audits Audits are not explicitly specified Documentation No documentation requirements explicitly specified, Evaluation/ Validation except for supplier certification for cleaning compounds and raw materials. There are no evaluation/validation requirements to determine whether a performed activity is achieving its goal. Only for raw materials, the facility is to \"verify\" compliance using supplier certification or some other method. Source: U.S. Food and Drug Administration, 2013. Page | 148
Vivat Keawdounglek (Ph.D.) Learning material of 1807307 (Food Sanitation and Safety) Part 12: Good Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Point (HACCP) 12.3 Hazard Analysis and Critical Control Point (HACCP) According to Pierson and Corlett (1997, p.1), the concept of the Hazard Analysis and Critical Control Point (HACCP) system was directly related to the Pillsbury Company’s projects in food production and research for the space program. The basics were developed by the Pillsbury Company in 1959 to ensure that the food product for The National Aeronautics and Space Agency (NASA) was not be contaminated with bacterial or vital pathogens, toxins, chemicals, or physical hazard causing an illness or injury. In other words, HACCP system enables food managers to identify the food and the processes that are most likely to cause foodborne illness. Moreover, HACCP approach is based on controlling time, temperature, and specific factors that are known to contribute to foodborne disease (McSwane, Rue, & Linton, 2005, p. 172). Although the HACCP system was significantly improved for food processing and manufacturing, it can be applied to all part of food supply chain including procurement, storage, cooking, and serving. In fact, standard operating procedures (SOP) for sanitation practice are a prerequisite for HACCP system. There are seven principles for HACCP system as can be seen in figure 12.3. 1.Conduct a Hazard Analysis 2. Identify the Critical Control Point 3.Establish critical limits for each critical control point 4.Establish monitoring procedures 5. Establish corrective action 6. Establish recordkeeping Procedures 7. Establish verification procedures Figure 12.3 Seven Principles for HACCP approach Source: Adapted from Knechtges, 2012, p. 280. Page | 149
Vivat Keawdounglek (Ph.D.) Learning material of 1807307 (Food Sanitation and Safety) Part 12: Good Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Point (HACCP) 12.3.1 Conduct a Hazard Analysis First of principals for HACCP system is hazard analysis. This process starts with a thorough review of your menu or product list to identify all of the potentially hazardous foods you serve. The flow diagram for food establishment (as can be seen in figure 11.4) should be demonstrated to easily identify the food hazard including biological, chemical, and physical hazard. For food preparation operations, three generalized process flows are described as being the most common (Knechtges, 2012, p. 294): 1) Food preparation without cooking step. An example process flow is as follows: ReceiveStore Prepare Hold Serve follows: 2) Food preparation with a cooking step. An example process flow is as ReceiveStore Prepare Cook Hold Serve 3) Food preparation involving complex step and procedures, usually passing through the temperature “danger zone” more than one. An example process flow is as follows: ReceiveStore Prepare Cook Cool Reheat Hot Hold Serve 12.3.2 Identify the Critical Control Point (CCP) As can be seen in McSwane et al. (2005, p.179), a critical control point (CCP) is an operation (practice, preparation steps, or procedure) in the flow of food which will prevent, eliminate, or reduce hazard to acceptable levels by creating the hazard control measures. The Critical Control Point (CCP) decision algorithm is provided in figure 12.5 and table 12.2 Page | 150
Vivat Keawdounglek (Ph.D.) Learning material of 1807307 (Food Sanitation and Safety) Part 12: Good Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Point (HACCP) Receiving Receiving Receiving Packaging Nonmeat Nonmeat Material Ingredients Ingredients Storage Storage Storage Packaging Nonmeat Nonmeat Material Ingredients Ingredients Assemble/ Grind/blend Assemble/ preweigh weight meat nonmeat ingredients Sausage Rework stuffer Process category: Raw product, Packaging/ ground labeling Product: Fresh pork sausage Finished Product Storage (cold) Shipping Figure 12.4 Example of Food Process Diagram for Fresh Pork Sausage Source: FSIS 1999, cited in Knechtges, 2012, p. 281. Page | 151
Table 12.2 Example of CCP 1. Process Step 2. Food Hazard 3. Resonably Likely to Occur? Receiving-Meat Biological-Samonella Yes Samonel and other pathogens in incomin pork trimmings Chemical-none Physical-Foreign No Plant rec material has been foreign m received Receiving-Nonmeat Biological-none ingredients/ Packaging Chemical-Not No Letter of Materials acceptable for intended received use nonmeat packagin Physical-metal, glass, No Plant rec wood that fore contami occurred several y Storage (cold)-meat Biological-Samonella Yes Pathoge and other pathogens likely to if tempe maintain level suf the grow Chemical-None Page152 Physical-None Source: FSIS 1999 cited in Knechtges, 2012, p. 285. Remark: B refer to biological hazard, C refer to chemical hazard, P refer
4.Basis 5. If “Yes” in column 3, what CCP measures could be applied to 1B lla may be present on prevent, eliminate, or reduce the ng raw product hazard to an acceptable level? 2B Certification from suppliers that product has been sampled for Samonella and meets performance standard cords show that there n no incidence of material in products d into the plant f guaranty are Maintain product temperature at or d from all supplier of below a level sufficient to preclude t ingredients and pathogen growth. ng material cords demonstrated eign material ination has not d during the past years. ens are reasonably o grow in this product erature is not ned at or below a fficient to preclude wth r to physical hazard.
Vivat Keawdounglek (Ph.D.) Learning material of 1807307 (Food Sanitation and Safety) Part 12: Good Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Point (HACCP) 12.3.3 Establish critical limits for each critical control point The critical limit is the application to reduce the hazard risk in safe level. Set critical limits to make sure that each critical control point effectively blocks a biological, chemical, or physical hazard. Critical limits should be thought of as the upper and lower boundary of food safety. To be effective, each criteria limit should be information from food regulatory code, scientific literature, experimental studies, and food safety expert (McSwane et al., 2005, p.183). Table 11.3 provide the criteria most frequency used for criteria limits. Table 12.3 Criteria most frequency used for critical limits Critical Limits Boundaries of Food Sanitation and Safety Time Limit the amount of time food is in the Temperature temperature dander zone during preparation and service process to 4 hours or less. Water Activity Keep potentially hazardous food at the below pH (acidity level) 5oC or above 57oC. Maintain specific cooking, cooling, reheating, and hot-holding temperature. Food with a water activity (Aw) of 0.85 or less do not support growth of disease-causing bacteria. Disease-causing bacteria do not grow in foods that have a pH of 4.6 or below. Source: McSwane et al., 2005, p. 183. 12.3.4 Establish monitoring procedures Monitoring criteria control points is one of the most importance activities in HACCP system. Monitoring is like quality control in that the monitoring step is going on during the process so adjustments can be made in the process before the product leaves the production line (Pierson & Corlett, 1997, p. 92). The loss of control of CCP for even a short period of time can result in the distribution of unsafe in food production. Thus, the HACCP team should carefully consider, plan, and implement the monitoring frequency. Whenever feasible, continuous monitoring using automated instrumentation is preferable such as a computer-controlled sensor. For biological monitoring, traditional microbiological laboratory methods are rarely useful for monitoring (Knechtges, 2012, p. 289). The example of critical limit and monitoring method as can be seen in table 12.4. Page | 153
Vivat Keawdounglek (Ph.D.) Learning material of 1807307 (Food Sanitation and Safety) Part 12: Good Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Point (HACCP) Table 12.4 Example of Critical limit and monitoring method Critical Control Potential Hazard control Critical Limit Monitoring Point (CCP) Hazard Measure Method Samonella may Supplier Receiving raw be on incoming Certification certification for Receiving meat for making raw product from suppliers Samonella must personnel will sausage (1B) that product has accompany each check each Pathogens are been sampled for shipment. shipment for Cold Storage of reasonably likely Samonella and Samonella meat (2B) to grow in this meets Raw product certification product if performance storage area shall temperature is not standard not exceed 5oC Maintenance maintained at or Maintain product personnel will below a level temperature at or record raw sufficient to below a level product storage preclude the sufficient to area temperature growth preclude every 2 hours pathogen growth. Source: Adapted from FDA, 2001 & FSIS, 1999 cited in Knechtges, 2012, p. 288. Remark: Critical limits are example only and should not be used for specific processes 12.3.5 Establish corrective action (McSwane, et al., 2005, pp. 189-190) If you detect that a critical limit was exceeded during the production of a HACCP monitored food, correct the problem immediately. The flow of food should not continue until all CCPs have been met. In first, determine what went wrong. Next, chose and apply the appropriate corrective action. For instance, if the temperature of the BBQ pork on your stream table is not at 57oC or higher, check the stream table to make sure that it is working properly and will keep food hot. At the same time, put the pork on the stove and reheat it rapidly to 74 oC. The pork should be discarded if you suspect it has been in the temperature danger zone for 4 hours or more. Additional corrective actions include having employees measure the temperature of the product at more frequent intervals and stir the pork to ensure the even distribution of heat throughout the product. Record the additional steps and verify that the critical limit is met using the revised system. Taking immediate corrective action is vital to the effectiveness of your food safety system. 12.3.6 Establish recordkeeping Procedures HACCP recordkeeping should include document related to development of HACCP Plan including list of HACCP team member and their assigned responsibilities, description of the food product and its intended use, flow diagram of the food preparation steps with CCPs note, hazard associated with each CCP and hazard control measure, critical limits, monitoring systems, corrective action plans for deviations from criteria limits, record keeping procedures, and procedure for verification of the HACCP system (McSwane et al., 2005 , pp.192-193). Table 12.5 is an example of Tubular format for HACCP plan. Page | 154
Vivat Keawdounglek (Ph.D.) Learning material of 1807307 (Food Sanitation and Safety) Part 12: Good Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Point (HACCP) 12.3.7 Establish verification procedures According to Pierson & Corlett (1997, p. 92),verification is like quality assurance in that it is a check on the system to confirm that the established critical control point were properly verified and corrective action, if need, was properly taken. There are two phase for HACCP plan verification, one is the improvement of the process or hazard control measure and the critical limits revised by publishing processing guideline, scientific article, and regulatory performance standard. The latter is the element of validation involves in-plant observation, measurements, testing or other procedure to ensure that the HACCP system is working as planned (Knechtges, 2012, p. 288). Hence, verification procedures may include (McSwane et al, 2005, pp. 191-192): -Imitation of appropriate verification inspection schedules; -A review of HACCP plan; -A review of CCP record; -A review of departures from critical limits and how they were corrected; -Visual inspection of food production operations to determine if CCPs are under control; -A random sample collection and analysis; -A review of the written record of verification inspections which certifies compliance with the HACCP plan or deviations from the plan and the corrective action taken; -Validation of the HACCP plan, including on-site review and verification of flow diagrams and CCP; -A review of the modification made to the HACCP plan. Verification inspections should be conducted under the following condition: -Routinely and unannounced to ensure that the selected CCPs are under control; -If it determined that intensive coverage of a specific food is needed because of new information concerning food safety; -When foods prepare at the establishment have been linked to a foodborne illness; -When established criteria have not been met; -To verify that change have been implemented correctly after a HACCP plan has been modified. Page | 155
Vivat Keawdounglek (Ph.D.) Learning material of 1807307 (Food Sanitation and Safety) Part 12: Good Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Point (HACCP) Verification report should contain the following information: -Existence of the HACCP plan and person(s) responsible for administering and updating plan; -The status of records associated with CCP monitoring; -Direct monitoring data of the CCP while in operation; certification that monitoring equipment is properly calibrated and in working order; deviations; and corrective action noted; -Direct monitoring data of the CCP while in operation; certification that monitoring equipment is properly calibrated and in working order; deviations; and corrective actions noted; -Any sample analyzed to verify that CCPs are under control (analyses may involve physical, chemical, biological or organoleptic method); -Modification to the HACCP plan; -Training and knowledge of individual responsible for monitoring CCPs. Page | 156
Table 12.5 Example of Tubular format for a HACCP plan Pro Me Firm name Firm Address Int 1 2 3 4 5 Critical Potential Critical What Control Hazard Limits Monitorin Point (CCP) How Fr Page | 157 Source: Adapted from FDA, 2001 cited in Knechtges, 2012, p. 291.
oduct Description ethod of distribution and Storage tended use and Consumer 6 7 8 9 10 ng Who Corrective Record Verification requency Action(s)
Vivat Keawdounglek (Ph.D.) Learning material of 1807307 (Food Sanitation and Safety) Part 12: Good Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Point (HACCP) Conclusion GMP or good manufacturing practice is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. Meanwhile, HACCP or hazard analysis and critical control point is an approach based on controlling time, temperature, and specific factors that are known to contribute to foodborne disease. There are seven process for HACCP as follows; 1) conduct a hazard analysis; 2) identify the critical control point (CCP);3) establish critical limits for each critical control point; 4) establish monitoring procedures; 5) establish corrective action plan; 6) establish recordkeeping Procedures; and 7) establish verification procedures. To control the quality of food product or food processing, GMP and HACCP should certificate in this processing. Questions; 1. Please describe the principle of GMP and HACCP. 2. If the process of ice-cream in a community has the process as this below, how to improve the quality of this process reducing the food hazard contamination? Preparation Mixing Cooling Packaging 3. What are the benefits of GMP and HACCP certification? Page | 158
Vivat Keawdounglek (Ph.D.) Learning material of 1807307 (Food Sanitation and Safety) Part 12: Good Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Point (HACCP) References Food Processing Environmental Assistance Center. (n.d.). Food Processing. Retrieved on April 7, 2015 from http://www.fpeac.org/fruit/ cornflowchart.html Knechtges, P.L. (2012). Food safety :theory and practice. Massachusetts: Jones&Bartlett Learning. McSwane, D., Rue, N.R., & Linton, R. (2005). Essential of food safety and sanitation (4th ed.).New jersey: Pearson Education. National Food Service Management Institute, The University of Mississippi. (2014). Standard Operating Procedures. Retrieved on April 7, 2015 from http://sop.nfsmi.org/ Pierson, M.D. & Corlett, D.A., editors. (1997). HACCP: Principles and Applications. New York: Chapman & Hall. U.S. Food and Drug Administration. (2013). Appendix E: Comparison of Food GMPs to Quality Systems and Other GMPs. Retrieved on April 21, 2015 from http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm110977.htm World Health Organization. (1997). A WHO guide to good manufacturing practice (GMP) requirements :part 1 Standard operating procedures andmaster formulae. Retrieved on April 21, 2015 from http://whqlibdoc.who.int/hq/1997/ who_vsq_97.01.pdf Page | 159
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