Daftar Isi
Artikel ini membahas utilitas farmasi yang mencakup sistem air, uap, gas, dan pendinginan sesuai standar EU GMP Annex-1. Untuk informasi lebih lanjut tentang pengendalian kontaminasi dalam manufaktur steril, lihat artikel tentang sterilisasi panas basah.
- 1. . The level of controls applied to utility systems shou…
- 2. . Utility system impact must be assessed and documented…
- 3. . Which of the following is considered a high-risk util…
- 4. . A utility that contacts materials that ultimately bec…
- 5. . Utilities must be designed, qualified, maintained, an…
- 6. . Critical parameters of high-risk utilities should be …
- 7. . Utility installation records must include: A. Equipme…
- 8. . Pipeline installation records should include: A. Empl…
- 9. . Pipes and ducts should NOT be present in cleanrooms u…
- 10. . If pipes must be present in cleanrooms, they should b…
- 11. . Water systems must be designed and maintained to prev…
- 12. . Measures to reduce microbial contamination in water s…
- 13. . Water produced should comply with: A. Internal SOPs o…
- 14. . Water systems must consider seasonal variation during…
- 15. . Turbulent flow in water distribution systems helps pr…
- 16. . Required flow rates for water systems must be: A. Est…
- 17. . WFI should be stored and distributed to minimize: A. …
- 18. . WFI distribution temperature is typically maintained:…
- 19. . WFI may be produced by distillation or: A. UV irradia…
- 20. . Hydrophobic vent filters on WFI tanks must be tested:…
- 21. . Controls must prevent what from forming on vent filte…
- 22. . Water system sterilisation or disinfection must follo…
- 23. . Chemical disinfection must be followed by: A. A valid…
- 24. . Microbial/endotoxin test results must be approved bef…
- 25. . Routine chemical and microbial monitoring of water sy…
- 26. . Sampling programmes must include: A. A single outlet …
- 27. . Sample plans must ensure that at least one representa…
- 28. . Alert level excursions require: A. No action B. Docum…
- 29. . Action limit excursions require investigation of: A. …
- 30. . WFI systems should include continuous monitoring such…
- 31. . Sensor locations for WFI continuous monitoring must b…
- 32. . Feed water to a clean steam generator must be: A. Sof…
- 33. . Clean steam must meet defined: A. Noise levels B. Col…
- 34. . Pure steam used for sterilisation must have condensat…
- 35. . Microbial testing of pure steam condensate is: A. Man…
- 36. . Quality of pure steam should be assessed periodically…
- 37. . Validated parameters for steam include: A. pH and col…
- 38. . Gases contacting product surfaces must meet appropria…
- 39. . Gases used in aseptic processes must be filtered with…
- 40. . Filters used on a batch basis must be: A. Stored outd…
- 41. . Any pipework after the final sterilising grade filter…
- 42. . Microbial monitoring of gas used in aseptic processin…
- 43. . Backflow risk from vacuum systems must be prevented b…
- 44. . Equipment associated with heating/cooling systems sho…
- 45. . Controls must exist for heating/cooling systems to co…
- 46. . Leaks in hydraulic or cooling systems must be: A. Ign…
- 47. . A suitable mechanism to prevent contamination from ut…
- 48. . One key design consideration for water systems is: A….
- 49. . A utility that “otherwise directly impacts the produc…
- 50. . Water system alert levels should be based on: A. Indu…
- 51. 1. Controls applied to utility systems should be based …
- 52. 2. The risk associated with utilities must be documente…
- 53. 3. Which utility is considered high risk? A. Office HVA…
- 54. 4. Utilities contacting materials that become part of t…
- 55. 5. Utilities that contact surfaces which contact produc…
- 56. 6. Utilities must be designed, qualified, and maintaine…
- 57. 7. High-risk utility critical parameters should undergo…
- 58. 8. Utility installation records must include: A. Employ…
- 59. 9. Pipeline records include all EXCEPT: A. Flow directi…
- 60. 0. Pipes and ducts should not be present in cleanrooms …
- 61. 1. If pipes are unavoidable in cleanrooms, they must be…
- 62. 2. Water systems must be designed to prevent: A. Temper…
- 63. 3. Water treatment systems should minimize: A. Mechanic…
- 64. 4. Filters within water systems require: A. No maintena…
- 65. 5. Water produced must comply with: A. Marketing claims…
- 66. 6. Water systems must be qualified and validated to mai…
- 67. 7. Seasonal variations must be considered in: A. Routin…
- 68. 8. Turbulent flow in water systems minimizes: A. Foamin…
- 69. 9. Flow rates for water systems must be: A. Guessed bas…
- 70. . WFI must be circulated at: A. Below 20°C B. Room temp…
- 71. 1. WFI may be produced by distillation or by: A. Sand f…
- 72. 2. WFI vent filters must be: A. Cleaned with alcohol B….
- 73. 3. Condensation on vent filters must be prevented by: A…
- 74. 4. Water system sterilization/disinfection must follow:…
- 75. 5. Chemical disinfection must be followed by: A. Visual…
- 76. 6. Water may be returned to use only after: A. Temperat…
- 77. 7. Ongoing monitoring of water systems includes: A. Che…
- 78. 8. Alert levels should be based on: A. Industry average…
- 79. 9. Sampling programmes must include: A. Tanks only B. A…
- 80. . Sample plans must include at least one sample: A. Per…
- 81. 1. Alert level excursions require: A. Immediate shutdow…
- 82. 2. Action limit excursions require investigation of: A….
- 83. 3. WFI systems should include continuous monitoring for…
- 84. 4. Sensor locations for WFI monitoring must be based on…
- 85. 5. Pure steam generator feed water must be: A. Softened…
- 86. 6. Pure steam must meet defined: A. pH limits only B. C…
- 87. 7. Condensate from pure steam must meet monograph requi…
- 88. 8. Microbial testing of steam condensate is: A. Mandato…
- 89. 9. Pure steam quality is periodically assessed using pa…
- 90. . Gases contacting product must meet: A. Odor requireme…
- 91. 1. Gas quality specifications must consider: A. Type an…
- 92. 2. Gases used in aseptic processing must be filtered us…
- 93. 3. Filters used for gases on a batch basis must be: A. …
- 94. 4. Pipework after the final sterilising grade filter mu…
- 95. 5. Microbial monitoring of gas used in aseptic processi…
- 96. 6. Backflow risks in vacuum/pressure systems must be pr…
- 97. 7. Heating and cooling equipment should be located: A. …
- 98. 8. Heating/cooling systems must have controls to contai…
- 99. 9. Leaks from hydraulic or cooling systems should be: A…
- 100. 0. A system to detect leaks from heating/cooling equipm…
1. . The level of controls applied to utility systems should be based on: A. Historical data B. Auditor preference C. Risk to product quality D. Cost of maintenance ANSWER – C
Jawaban: C2. . Utility system impact must be assessed and documented as part of the: A. Preventive Maintenance Plan B. CCS (Contamination Control Strategy) C. Training Matrix D. Recall Process ANSWER – B
Jawaban: B
3. . Which of the following is considered a high-risk utility? A. Lighting system B. HVAC condensate C. Utilities that directly contact the product D. Office compressed air ANSWER – C
Jawaban: C
4. . A utility that contacts materials that ultimately become part of the product is considered: A. Low risk B. Moderate risk C. High risk D. No risk ANSWER – C
Jawaban: C
5. . Utilities must be designed, qualified, maintained, and monitored to: A. Improve building energy efficiency B. Ensure the system functions as expected C. Reduce employee workload D. Meet financial targets ANSWER – B
Jawaban: B
6. . Critical parameters of high-risk utilities should be subject to: A. Annual review only B. Regular trend analysis C. Only manual checks D. No monitoring ANSWER – B
Jawaban: B
7. . Utility installation records must include: A. Equipment prices B. Staff shift schedules C. Current drawings and system specifications D. Manufacturing batch records ANSWER – C
Jawaban: C
8. . Pipeline installation records should include: A. Employee qualifications B. Pipeline flow direction and slopes C. Vendor audit reports D. Cleaning SOPs ANSWER – B
Jawaban: B
9. . Pipes and ducts should NOT be present in cleanrooms unless: A. Required for production B. Avoidable C. Unavoidable D. Cheap to install ANSWER – C
Jawaban: C
10. . If pipes must be present in cleanrooms, they should be: A. Buried in walls B. Installed to avoid recesses and allow easy cleaning C. Left exposed without cleaning access D. Painted for easier identification ANSWER – B
Jawaban: B
11. . Water systems must be designed and maintained to prevent: A. Excessive temperature B. Noise C. Microbiological contamination D. Water hardness ANSWER – C Sterilization EUGMP- Annex-1
Jawaban: C
12. . Measures to reduce microbial contamination in water systems include: A. Using high pressure B. Sloping pipes for drainage C. Adding dyes D. Storing water at room temperature ANSWER – B
Jawaban: B
13. . Water produced should comply with: A. Internal SOPs only B. Current monograph of the relevant Pharmacopeia C. VIP inspection reports D. Management approval ANSWER – B
Jawaban: B
14. . Water systems must consider seasonal variation during: A. Calibration B. Qualification and validation C. Construction only D. Risk assessment only ANSWER – B
Jawaban: B
15. . Turbulent flow in water distribution systems helps prevent: A. System vibration B. Biofilm formation C. Rust D. Evaporation ANSWER – B
Jawaban: B
16. . Required flow rates for water systems must be: A. Estimated B. Recorded during validation only C. Established during qualification and routinely monitored D. Not monitored ANSWER – C
Jawaban: C
17. . WFI should be stored and distributed to minimize: A. Temperature fluctuations only B. Microbial growth C. Operator handling D. Particulate shedding ANSWER – B
Jawaban: B
18. . WFI distribution temperature is typically maintained: A. Below 20°C B. Above 70°C C. At 35°C D. Room temperature ANSWER – B
Jawaban: B
19. . WFI may be produced by distillation or: A. UV irradiation alone B. Reverse osmosis + appropriate techniques C. Carbon filtration alone D. Chlorination ANSWER – B
Jawaban: B
20. . Hydrophobic vent filters on WFI tanks must be tested: A. Every five years B. Only before installation C. Before installation and after use D. Never ANSWER – C
Jawaban: C
21. . Controls must prevent what from forming on vent filters? A. Dust buildup B. Condensation C. Oil residue D. Ice crystals ANSWER – B
Jawaban: B
22. . Water system sterilisation or disinfection must follow: A. Operator preference B. A predetermined schedule C. Annual review D. No documented plan ANSWER – B
Jawaban: B
23. . Chemical disinfection must be followed by: A. A validated rinsing procedure B. Visual inspection only C. Microbial testing only D. Immediate system restart ANSWER – A
Jawaban: A
24. . Microbial/endotoxin test results must be approved before: A. Cleaning equipment B. Water system is returned to use C. The next audit D. Any maintenance is done ANSWER – B
Jawaban: B
25. . Routine chemical and microbial monitoring of water systems is: A. Optional B. Required only annually C. Required regularly D. Only for new systems ANSWER – C
Jawaban: C
26. . Sampling programmes must include: A. A single outlet B. All outlets and points of use at specified intervals C. Only critical points D. Only routine sampling of tanks ANSWER – B
Jawaban: B
27. . Sample plans must ensure that at least one representative sample is taken: A. Per month B. Every hour C. Every day that water is used in manufacturing D. Only during qualification ANSWER – C
Jawaban: C
28. . Alert level excursions require: A. No action B. Documentation and review C. Automatic shutdown D. Operator reprimand ANSWER – B
Jawaban: B
29. . Action limit excursions require investigation of: A. Market complaints B. Root cause and impact on product quality C. Employee attendance D. Utility cost ANSWER – B
Jawaban: B
30. . WFI systems should include continuous monitoring such as: A. UV absorbance only B. TOC and conductivity C. Pressure only D. Color monitoring ANSWER – B
Jawaban: B
31. . Sensor locations for WFI continuous monitoring must be based on: A. Equipment availability B. Operator preference C. Risk D. Cost ANSWER – C
Jawaban: C
32. . Feed water to a clean steam generator must be: A. Softened only B. Appropriately purified C. At room temperature D. Chlorinated ANSWER – B
Jawaban: B
33. . Clean steam must meet defined: A. Noise levels B. Color criteria C. Chemical and endotoxin limits D. Odor criteria ANSWER – C
Jawaban: C
34. . Pure steam used for sterilisation must have condensate that meets the monograph for: A. Drinking water B. Sterile water for irrigation C. WFI D. Process water ANSWER – C
Jawaban: C
35. . Microbial testing of pure steam condensate is: A. Mandatory B. Not mandatory C. Optional D. Prohibited ANSWER – B
Jawaban: B
36. . Quality of pure steam should be assessed periodically against: A. HVAC setpoints B. Vendor recommendations C. Validated parameters D. Marketing requirements ANSWER – C
Jawaban: C
37. . Validated parameters for steam include: A. pH and color B. Non-condensable gases, dryness, superheat C. Conductivity only D. TOC only ANSWER – B
Jawaban: B
38. . Gases contacting product surfaces must meet appropriate: A. Color and odor B. Chemical, particulate, and microbial quality C. Oxygen content D. Pressure levels only ANSWER – B
Jawaban: B
39. . Gases used in aseptic processes must be filtered with maximum pore size: A. 0.45 µm B. 5.0 µm C. 1.0 µm D. 0.22 µm ANSWER – D
Jawaban: D
40. . Filters used on a batch basis must be: A. Stored outdoors B. Replaced after each use C. Integrity tested and reviewed during batch release D. Not labeled ANSWER – C
Jawaban: C
41. . Any pipework after the final sterilising grade filter must be: A. Heated B. Painted C. Sterilised D. Disconnected ANSWER – C
Jawaban: C
42. . Microbial monitoring of gas used in aseptic processing should be performed: A. Never B. Only at installation C. Periodically at point of use D. Only after a deviation ANSWER – C
Jawaban: C
43. . Backflow risk from vacuum systems must be prevented by: A. Employee training B. Cooling the lines C. Mechanisms preventing backflow D. Increasing vacuum strength ANSWER – C
Jawaban: C
44. . Equipment associated with heating/cooling systems should be located: A. Inside the filling room B. Next to product contact surfaces C. Outside the filling room D. Near exit doors ANSWER – C
Jawaban: C
45. . Controls must exist for heating/cooling systems to contain: A. Temperature drift B. System fluids and spillage C. Employee access D. Electrical usage ANSWER – B
Jawaban: B
46. . Leaks in hydraulic or cooling systems must be: A. Ignored if small B. Painted over C. Detectable D. Repaired only annually ANSWER – C
Jawaban: C
47. . A suitable mechanism to prevent contamination from utilities is: A. Flow meters B. Backflow preventers C. Color indicators D. Larger pipes ANSWER – B
Jawaban: B
48. . One key design consideration for water systems is: A. Creating dead legs B. Ensuring sloped piping C. Increasing holding times D. Eliminating circulation ANSWER – B
Jawaban: B
49. . A utility that “otherwise directly impacts the product” is considered: A. High risk B. Low risk C. Medium risk D. No risk ANSWER – A
Jawaban: A
50. . Water system alert levels should be based on: A. Industry averages B. Historical manufacturing deviations only C. Initial qualification data, requalification data, and ongoing monitoring D. Auditor preference ANSWER – C
Jawaban: C
51. 1. Controls applied to utility systems should be based on: A. Cost of equipment B. Auditor preference C. Risk to product quality D. Operator experience ANSWER – C
Jawaban: C
52. 2. The risk associated with utilities must be documented as part of the: A. Environmental Monitoring Plan B. Contamination Control Strategy (CCS) C. Change Control D. Training Matrix ANSWER – B
Jawaban: B
53. 3. Which utility is considered high risk? A. Office HVAC B. Electrical power cables C. Water directly contacting product D. Lighting utilities ANSWER – C
Jawaban: C
54. 4. Utilities contacting materials that become part of the product are considered: A. Low risk B. No risk C. High risk D. Medium risk ANSWER – C
Jawaban: C
55. 5. Utilities that contact surfaces which contact product are considered: A. High risk B. Low risk C. No risk D. Negligible risk ANSWER – A
Jawaban: A
56. 6. Utilities must be designed, qualified, and maintained to: A. Minimize installation costs B. Function as expected C. Reduce downtime only D. Meet ergonomic requirements ANSWER – B
Jawaban: B
57. 7. High-risk utility critical parameters should undergo: A. Daily calibration B. Trending as needed C. Regular trend analysis D. No trend analysis ANSWER – C
Jawaban: C
58. 8. Utility installation records must include: A. Employee names B. Current drawings and specifications C. Vendor financial details D. Cleaning logs ANSWER – B
Jawaban: B
59. 9. Pipeline records include all EXCEPT: A. Flow direction B. Pipe slopes C. Pipe color D. Pipe diameter and length ANSWER – C
Jawaban: C
60. 0. Pipes and ducts should not be present in cleanrooms unless: A. They are unavoidable B. They are new C. They are easy to hide D. They are stainless steel ANSWER – A
Jawaban: A
61. 1. If pipes are unavoidable in cleanrooms, they must be installed to: A. Allow easy painting B. Avoid recesses and difficult-to-clean surfaces C. Maximize space usage D. Allow operator access ANSWER – B
Jawaban: B
62. 2. Water systems must be designed to prevent: A. Temperature rise B. Operator error C. Microbiological contamination D. High conductivity ANSWER – C
Jawaban: C
63. 3. Water treatment systems should minimize: A. Mechanical wear B. Microbial contamination and endotoxin formation C. Water pressure D. Filter differential pressure ANSWER – B
Jawaban: B
64. 4. Filters within water systems require: A. No maintenance B. Monthly replacement C. Special attention to monitoring and maintenance D. Color coding ANSWER – C
Jawaban: C
65. 5. Water produced must comply with: A. Marketing claims B. Current monograph of relevant Pharmacopeia C. Supplier recommendations D. Historic standards ANSWER – B
Jawaban: B
66. 6. Water systems must be qualified and validated to maintain: A. Microbial control only B. Physical, chemical, and microbial control C. Temperature control only D. Pressure stability ANSWER – B
Jawaban: B
67. 7. Seasonal variations must be considered in: A. Routine maintenance B. Qualification and validation C. Decommissioning D. Procurement ANSWER – B
Jawaban: B
68. 8. Turbulent flow in water systems minimizes: A. Foaming B. Pressure drops C. Microbial adhesion and biofilm formation D. Energy consumption ANSWER – C
Jawaban: C
69. 9. Flow rates for water systems must be: A. Guessed based on usage B. Established during qualification and routinely monitored C. Based on supplier documents only D. Checked only annually ANSWER – B
Jawaban: B
70. . WFI must be circulated at: A. Below 20°C B. Room temperature C. Above 70°C D. Between 30–40°C ANSWER – C
Jawaban: C
71. 1. WFI may be produced by distillation or by: A. Sand filtration alone B. Reverse osmosis with additional techniques C. UV treatment only D. Boiling ANSWER – B
Jawaban: B
72. 2. WFI vent filters must be: A. Cleaned with alcohol B. Integrity tested before installation and after use C. Replaced monthly D. Stored at ambient temperature ANSWER – B
Jawaban: B
73. 3. Condensation on vent filters must be prevented by: A. Cooling the filter B. Heating the filter C. Spraying disinfectant D. Increasing airflow ANSWER – B
Jawaban: B
74. 4. Water system sterilization/disinfection must follow: A. Operator judgement B. A predetermined schedule C. Seasonal planning only D. Weekly scheduling ANSWER – B
Jawaban: B
75. 5. Chemical disinfection must be followed by: A. Visual inspection B. Validated rinsing/flushing C. Immediate system start-up D. Pressure testing only ANSWER – B
Jawaban: B
76. 6. Water may be returned to use only after: A. Temperature testing B. Chemical testing approval + microbial/endotoxin compliance C. Operator approval D. Vendor notification ANSWER – B
Jawaban: B
77. 7. Ongoing monitoring of water systems includes: A. Chemical and microbial monitoring B. Pressure monitoring only C. Temperature spot checks D. Operator logs ANSWER – A
Jawaban: A
78. 8. Alert levels should be based on: A. Industry averages B. Initial qualification and subsequent monitoring data C. Last year’s audit report D. Supplier recommendations ANSWER – B
Jawaban: B
79. 9. Sampling programmes must include: A. Tanks only B. All outlets and points of use C. One outlet selected randomly D. Only points with highest flow ANSWER – B
Jawaban: B
80. . Sample plans must include at least one sample: A. Per month B. Per manufacturing shift C. Per day that water is used D. Every hour ANSWER – C
Jawaban: C
81. 1. Alert level excursions require: A. Immediate shutdown B. Documentation and review C. No action D. Filter replacement only ANSWER – B
Jawaban: B
82. 2. Action limit excursions require investigation of: A. Employee competence B. Root cause and product impact C. Market complaints D. Training records ANSWER – B
Jawaban: B
83. 3. WFI systems should include continuous monitoring for: A. UV absorbance B. Color C. TOC and conductivity D. Viscosity ANSWER – C
Jawaban: C
84. 4. Sensor locations for WFI monitoring must be based on: A. Cost B. Operator preference C. Risk D. Convenience ANSWER – C
Jawaban: C
85. 5. Pure steam generator feed water must be: A. Softened only B. Appropriately purified C. Derived from municipal water directly D. UV treated only ANSWER – B
Jawaban: B
86. 6. Pure steam must meet defined: A. pH limits only B. Chemical and endotoxin limits C. Pressure ranges only D. Flow rates only ANSWER – B
Jawaban: B
87. 7. Condensate from pure steam must meet monograph requirements for: A. Potable water B. Water for injection (WFI) C. Sterile water for irrigation D. Cold water ANSWER – B
Jawaban: B
88. 8. Microbial testing of steam condensate is: A. Mandatory B. Not mandatory C. Performed weekly D. Not allowed ANSWER – B
Jawaban: B
89. 9. Pure steam quality is periodically assessed using parameters including: A. TOC levels only B. Conductivity C. Non-condensable gases, dryness value, superheat D. Microbial count ANSWER – C
Jawaban: C
90. . Gases contacting product must meet: A. Odor requirements only B. Chemical, particulate & microbial quality requirements C. Pressure consistency D. Only microbial requirements ANSWER – B
Jawaban: B
91. 1. Gas quality specifications must consider: A. Type and use of gas B. Room size C. Employee shift patterns D. Operator convenience ANSWER – A
Jawaban: A
92. 2. Gases used in aseptic processing must be filtered using: A. 1.0 µm filters B. 0.45 µm filters C. 0.22 µm sterilising grade filters D. 5.0 µm filters ANSWER – C
Jawaban: C
93. 3. Filters used for gases on a batch basis must be: A. Painted B. Integrity tested and results reviewed at batch release C. Used indefinitely D. Washed with water ANSWER – B
Jawaban: B
94. 4. Pipework after the final sterilising grade filter must be: A. Labeled B. Sterilised C. Painted D. Replaced monthly ANSWER – B
Jawaban: B
95. 5. Microbial monitoring of gas used in aseptic processing should occur: A. Never B. Only during installation C. Periodically at point of use D. Only during deviations ANSWER – C
Jawaban: C
96. 6. Backflow risks in vacuum/pressure systems must be prevented by: A. Administrative controls B. Backflow prevention mechanisms C. Operator awareness D. Using wider pipes ANSWER – B
Jawaban: B
97. 7. Heating and cooling equipment should be located: A. Inside the filling room B. In the warehouse C. Outside the filling room D. Near product-contact areas ANSWER – C
Jawaban: C
98. 8. Heating/cooling systems must have controls to contain: A. Temperature fluctuations B. Spillage or cross contamination of system fluids C. Vibration D. Steam leaks only ANSWER – B
Jawaban: B
99. 9. Leaks from hydraulic or cooling systems should be: A. Covered B. Painted C. Detectable D. Ignored if small ANSWER – C
Jawaban: C
100. 0. A system to detect leaks from heating/cooling equipment may include: A. Pressure gauges B. An indication system for leakage C. Temperature probes D. Manual inspections only ANSWER – B Reference – EU Guidelines for GMP- Annex-1 Categories Engineering , QUESTIONS & ANSWERS Tags Achalpur , Adoni , Agartala , Agra , Ahmedabad , Ahmednagar , Aizawl , Ajmer , Akola , Alappuzha , Aligarh , Alwar , Amaravati , Ambala , Ambarnath , Ambattur , Amravati , Amritsar , Amroha , Anand , Anantapur , Andaman and Nicobar Islands , Andhra Pradesh , Arrah , Arunachal Pradesh , Asansol , Assam , Aurangabad , Avadi , Badlapur , Bagaha , Baharampur , Bahraich , Bally , Baranagar , Bardhaman , Bareilly , Barshi , Bathinda , Beed , Begusarai , Belgaum , Bellary , Bengaluru , Berhampur Muzaffarpur , Bettiah , Bhagalpur , Bhalswa Jahangir Pur , Bharatpur , Bhatpara , Bhavnagar , Bhilai , Bhilwara , Bhimavaram , Bhind , Bhiwandi , Bhiwani , Bhopal , Bhubaneswar , Bhusawal , Bidar , Bidhan Nagar , Bihar , Bihar Sharif , Bijapur , Bikaner , Bilaspur , Bokaro , Bulandshahr , Burhanpur , Buxar , Chandigarh , Chandrapur , Chapra , Chennai , Chhattisgarh , Chittoor , Coimbatore , Cuttack , Dadra and Nagar Haveli district , Danapur , Darbhanga , Davanagere , Dehradun , Dehri , Delhi , Deoghar , Dewas , Dhanbad , Dharmavaram , Dhule , Dindigul , Durgapur , Eluru , Erode , Etawah , Faridabad , Farrukhabad , Fatehpur , Firozabad , Gadag-Betageri , Gandhidham , Gandhinagar , Gaya , Ghaziabad , Goa , Gondia , Gopalpur , Gorakhpur , Gudivada , Gujarat , Gulbarga , Guna , Guntakal , Guntur , Gurgaon , Guwahati , Gwalior , Hajipur , Haldia , Hapur , Haridwar , Haryana , Himachal Pradesh , Hindupur , Hinganghat , Hospet , Howrah , Hubli–Dharwad , Hugli-Chuchura , Hyderabad , Ichalkaranji Karnal , Imphal , Indore , Jabalpur , Jaipur , Jalandhar , Jalgaon , Jalna , Jamalpur , Jammu , Jammu and Kashmir , Jamnagar , Jamshedpur , Jaunpur , Jehanabad , Jhansi , Jharkhand , Jodhpur , Junagadh , Kadapa , Kakinada , Kalyan-Dombivli , Kamarhati , Kanpur , Karaikudi , Karawal Nagar , Karimnagar , Karnataka , Katihar , Kavali , Kerala , Khammam , Khandwa , Kharagpur , Khora , Kirari Suleman Nagar Barasat , Kishanganj , Kochi , Kolhapur , Kolkata , Kollam , Kota , Kottayam , Kozhikode , Kulti , Kurnool , Ladakh , Lakshadweep , Latur , Loni , Lucknow , Ludhiana , Machilipatnam , Madanapalle , Madhya Pradesh , Madhyamgram , Madurai , Maharashtra , Mahesana , Maheshtala , Malda , Malegaon , Mangalore , Mango , Manipur , Mathura , Mau , Meerut , Meghalaya , Mira-Bhayandar , Miryalaguda , Mirzapur , Mizoram , Moradabad , Morena , Morvi , Motihari , Mumbai , Munger , Murwara , Muzaffarnagar , Mysore , Nadiad , Nagaland , Nagarcoil , Nagpur , Naihati , Nanded , Nandurbar , Nandyal , Nangloi Jat , Narasaraopet , Nashik , Navi Mumbai , Nellore , New Delhi , Nizamabad , Noida , North Dumdum , Odisha , Ongole , Orai , Osmanabad , Ozhukarai , Pali , Pallavaram , Panchkula , Panihati , Panipat , Panvel , Parbhani , Patiala , Patna , Pimpri-Chinchwad , Prayagraj , Proddatur , Puducherry , Pune , Punjab , Purnia , Rae Bareli , Raichur , Raiganj , Raipur , Rajahmundry , Rajasthan , Rajkot , Rajpur Sonarpur , Ramagundam , Rampur , Ranchi , Ratlam , Raurkela Industrial Township , Rewa , Rohtak Korba , Rourkela Durg , Sagar , Saharanpur , Saharsa , Salem , Sambalpur , Sambhal , Sangli-Miraj & Kupwad , Sasaram , Satara , Satna , Secunderabad , Serampore , Shahjahanpur , Shimla , Shivamogga , Shivpuri , Sikar Thoothukudi , Sikkim , Siliguri , Singrauli , Sirsa , Siwan , Solapur , Sonipat , South Dumdum , Sri Ganganagar , Srikakulam , Srinagar , Sultan Pur Majra , Surat , Surendranagar Dudhrej , Suryapet , Tadepalligudem , Tadipatri , Tamil Nadu , Telangana , Tenali , Thane , Thanjavur , Thiruvananthapuram , Thrissur , Tiruchirappalli , Tirunelveli , Tirupati , Tiruppur , Tiruvottiyur , Tripura , Tumkur , Udaipur , Udgir , Ujjain , Ulhasnagar , Uluberia , Unnao , Uttar Pradesh , Uttarakhand , Vadodara , Varanasi , Vasai-Virar , Vellore , Vijayanagaram , Vijayawada , Visakhapatnam , Warangal , Wardha , West Bengal , Yamunanagar , Yavatmal Terminally Sterilized Products EUGMP- Annex-1 Personnel EUGMP- Annex-1
Jawaban: B
Sumber: EU Guidelines for GMP – Annex-1
