In the pharmaceutical industry, quality risk assessment in pharma entails the identification of hazards as well as the investigation and assessment of the risks connected to their exposure. Three key questions are frequently used as a guide to precisely describing the risk(s) for Quality Risk Assessment purposes:
What might fail?
What is the chance that something will go wrong?
What are the repercussions’ severity?
Risk Analysis: The evaluation of the risk posed by the cited risks is known as risk analysis. The technique of relating the likelihood of occurrence and seriousness of injuries might be qualitative or quantitative.
Risk Evaluation: In a risk evaluation, the detected and analysed risks are compared to predetermined risk criteria.
Risk Reduction: Decision-making for risk reduction and/or risk acceptance is part of risk control. Risk control’s goal is to bring it down to a manageable level.
Risk Acceptance: Accepting risk means making the choice to do so. Risk acceptance may involve making a formal choice to accept the residual risk or it may involve making a passive decision without specifying the residual hazards.
Risk Communication: Information regarding risk and risk management is shared between decision-makers and other parties through risk communication. At any point of the risk management procedure, parties may communicate.
Risk Review: The process of quality management should include ongoing risk management. Implementing a system for reviewing or keeping track of events is necessary.
1. Risk Assessment for Sampling & Cleaning Station
2. Post Risk Assessment for Compression Machine
3. Post Risk Analysis For Automatic Measuring Cup Replacement
4. Post Risk Analysis for Automatic Rotary Vacuumetric Dry Syrup Filling with ROPP Capping Machine
5. Post Risk Analysis for Automatic Vertical Round Bottle Sticker Labelling Machine
6. Post Risk Analysis for Induction Cap Sealing Machine
7. Post Risk Analysis for Water System
8. Post Risk Assessment for Automatic Air Jet Bottle Air and Vacuum Cleaning Machine
9. Post Risk Assessment for Bin Blender
10. Post Risk Assessment for Blister Packing Machine
11. Post Risk Assessment for Coating machine
12. Post Risk Assessment for Colloidal Mill
13. Post Risk Assessment for FBD
14. Post Risk Assessment for HVAC
15. Post Risk Assessment for Metal Detector cum De-Dustor
16. Post Risk Assessment for Multimill
17. Post Risk Assessment for Octagonal Blender
18. Post Risk Assessment for Paste Kettle
19. Post Risk Assessment for Powder Transfer System
20. Post Risk Assessment for RMG
21. Post Risk Assessment for Roll Compactor
22. Post Risk Assessment for Strip Packing Machine
23. Post Risk Assessment for Tablet & Capsule Sorter
24. Post Risk Assessment for Tablet Inspection
25. Post Risk Assessment for Vacuum Transfer System
26. Post Risk Assessment for Vibro Sifter
27. Post Risk Assessment of Tube Filling Machine
28. Post Risk Assessment Protocol of Wimco Tube Filling Machine
29. Post Risk Assessment-Autocartonator
30. Pre Risk Analysis for Automatic Measuring Cup Placement
31. Pre Risk Analysis for Automatic Rotary Vacuumatric Dry Syrup Filling with ROPP Capping Machine
32. Pre Risk Analysis for Automatic Vertical Round Bottles Sticker Labelling Machine
33. Pre Risk Analysis for Combo Metal Detector cum Deduster
34. Pre Risk Analysis for Water System
35. Pre Risk Assessment for Automatic Air Jet Bottle Air and Vacuum Cleaning Machine
36. Pre Risk Assessment for Coating machine
37. Pre Risk Assessment for Colloidal Mill
38. Pre Risk Assessment for Comill
39. Pre Risk Assessment for FBD
40. Pre Risk Assessment for Multimill
41. Pre Risk Assessment for Octagonal Blender
42. Pre Risk Assessment for Paste Kettle
43. Pre Risk Assessment for Powder Transfer System
44. Pre Risk Assessment for RMG
45. Pre Risk Assessment for Roll Compactor
46. Pre Risk Assessment for Tablet and Capsule Sorter
47. Pre Risk Assessment for Vacuum Transfer System
48. Pre Risk Assessment for Vacuum Tray Dryer
49. Pre Risk Assessment for Vertical Deduster cum Metal Detector
50. Pre Risk Assessment for Vibro Sifter
51. Pre Risk Assessment of Strip Packing
52. Pre Risk Assessment-Autocartonator
53. Pre Risk Assessment-Blister Packing Machine
54. Pre-Risk Assessment for Bin Blender
55. Pre-Risk Assessment for HVAC
56. Pre-risk Assessment of Tube filling machine
57. Transport validation Risk Assessment
58. Risk assessment report on Nitrosamines Impurity-Cefpodoxime Proxetil
59. Risk Assessment of Water for Injection
60. Risk Assessment of Vial Washing Machine
61. Risk Assessment of Vial Sealing Machine
62. Risk Assessment of Vial Filling & Stoppering Machine
63.Risk Assessment of Vial Depyrogenation Tunnel
64. Risk Assessment of Sticker Labeling Machine
65. Risk Assessment of Sterile Formulation Facility
66. Risk Assessment of Purified Water System
67. Risk Assessment of Pure Steam Generation System
69. Risk Analysis for Online Non-Viable Particle Count Sampling Location
71. Protocol for Risk Assessment of Warehouse facility
72. Protocol for Risk Assessment & Mitigation of Process Simulation Study
76. Pre-risk Assessment Protocol of Wimco Tube filling machine
78. Risk Assessment for Process Validation for 5-AMINO LEVULINIC ACID HCL (Stage 1)
79. Risk Assessment for Process Validation for 5-AMINO LEVULINIC ACID HCL (Stage II)
80. Risk Assessment for Process Validation for 5-AMINO LEVULINIC ACID HCL (Final)
81. Risk Assessment of Holding Vessel
82. Risk Assessment of HPHV Steam Sterilizer (Micro)
83. Risk Assessment of HPHV Steam Sterilizer
85. Risk Assessment of Dispensing Booth
86. Risk Assessment of Compressed Air system
87. Risk Assessment of Compounding Vessel
88. Risk Assessment of Cartonator
89. Risk Assessment of Blister Packing machine
90. Risk Assessment of Ampoule Washing Machine
91. Risk Assessment of Ampoule Filling & Sealing Machine
92. Risk Assessment of Ampoule Depyrogenation Tunnel
93. Risk Assessment for Transfer of Product Transfer
94. Risk Assessment for the Steam Sterilizer
95. Risk assessment for the cross contamination in the common corridor
96. Risk Assessment for Rinse Sample Reduction
97. Risk Assessment for Process Validation
98. Risk Assessment for Process validation
99. Risk Assessment and Mitigation of Cefixime Trihydrate
100. Risk Assessment for Plant Equipment
101. Risk Assessment for Media Fill Activity
102. Risk Assessment for Lyophilizer
103. Risk Assessment for Liquid Vial Filling Machine
104. Risk Assessment for Laminar Air Flow
105. Risk Assessment for Filling machine (Eye Drop)
106. Risk Assessment for Facility Processes
107. Risk Assessment for effect of seasonal variation on HVAC system
108. Risk Assessment for Dry Powder Filling Machine
109. Risk Assessment for De-dusting tunnel
110. Risk Assessment for Compressed Air
111. Risk Assessment for Common Change Room
112. Risk Assessment for Change of Compression machine
113. Risk Assessment for Batch size
114. Risk Assessment for Air Handling Unit
115. Risk Assessment for Dispensed Raw Material Transferred to Manufacturing
116. Risk Assessment Document For Vial Washing Machine
118. Risk Assessment Document For Steam Heat Sterilizer (Autoclave)
119. Risk Assessment Document For Solution Preparation Tank
120. Risk Assessment Document For Dispensing Booth
124. Risk Assessment and impact analysis of PLC System for High Shear Mixer Granulator (RMG-600LTR)
125. Risk Assessment and Impact analysis of PLC System for Fluid Bed Dryer (FBD-250 KG)
126. Risk Assessment for PLC of Autocoater
127. Risk Assessment & Mitigation for uses of Under Test Beta -Naphthol Complex in Cefaclor batches
128. Quality Risk Assessment of Packing Operation
129. Risk Analysis Study Protocol cum Report for Chiller Shut Down
130. Risk Analysis Study Protocol cum Report for Containers used in Manufacturing
132. Risk Assessment for Cyclosporine Eye Drops
133. Risk Analysis Study Report for Rinse and Swab Discontinuation
134. Risk Analysis Study Protocol for Renovation
135. Risk Analysis Study Report for Renovation
136. Risk Assessment for Filter Integrity Testing
137. Risk Assessment for Warehouse facility
138. Risk Assessment for Purified Water Generation & Distribution System
141. Risk-Assessment for Softgel manufacturing facility
142. Risk Analysis Study Protocol cum Report for Reducing testing of Compressed Air User Points
143. Risk Assessment for missing of Manufacturing & Expiry date on Blister
146. Quality Risk Assessment (OSD) Manufacturing
147. Risk Assessment for Vendor Approval and Evaluation
148.Risk Assessment for House Keeping Personnel Administration
149. Risk Assessment Protocol for Mix up & Cross Contamination
150. Risk Assessment for Facility Process
151. Risk Assessment of Mix-Ups from Dispensing to Dispatch
152. Risk Assessment for Process Mapping from Dispensing to Dispatch
153. Elemental Impurities Risk Assessment for Paracetamol Tablets
154. Risk Assessment for Oral Solid Dosage form
155. Quality Risk Assessment (OSD) Quality Control
156. Risk Assessment for Role & Responsibility of QA
157.Risk Assessment for Introduction of New Hardgelatin Capsule in Manufacturing Facility
158 Quality Risk Assessment for External Preparations
159 Quality Risk Assessment (OSD) Transfer of scrap
160 Risk Assessment for Balance Verification
161 Quality Risk Assessment Dispensing of External Preparations
162 Quality Risk Assessment for Batch Release (OSD)
163 Quality Risk Assessment for Blending (OSD)
164 Quality Risk Assessment for Coating (OSD)
165 Quality Risk Assessment for Compression (OSD)
166 Quality Risk Assessment for Dispensing (OSD)
167 Quality Risk Assessment for Material Staging after Dispensing (OSD)
168 Quality Risk Assessment for Sampling(OSD)
169 Quality Risk Assessment for Storage & Dispatch of Finished Goods(OSD)
170 Quality Risk Assessment for Visual Inspection(OSD)
171 Quality Risk Assessment fro Labeling (OSD)
172 Risk Assessment for Blister Packing Machine (OSD)
173 Risk Assessment for Different API used in commercial batches
174 Risk Assessment Protocol for Mix up & Cross Contamination
175 Quality Risk Assessment Batch release
176 Risk Assessment Protocol for Product Recall & Withdrawal
177 Risk Assessment for New Product (Tablet)
178. Quality Risk Assessment for Vendor Evaluation (1)
179. Quality Risk Assessment Protocol for Vendor Approval and evaluation
180. Risk Assessment for Removal of Lower Secondary Packing area
181. Risk Assessment for Interlocking & Pressure Gauges of Facility
182. Risk Assessment for Topical Solution
183. Risk Assessment for New Packing Line
184. Risk Assessment for Interlocking
185. Risk Assessment for Malfunctioning of Metal Detector
186. Risk Assessment for Vendor Qualification through Questionnaire instead of Site Audit
187. Risk Assessment for Carton mixing
189. Risk Assessment for Coated Tablet Defects
190. Risk Assessment for Gowning procedure
191. Risk Assessment for Hydrocorticosone Sodium Succinate Dry Powder Injection
193. Risk Assessment for Purified Water Generation & Distribution System
194. Risk Assessment for Document Issuance Control
195. Risk Assessment for Additional Material taken during Process
196. Quality Risk Assessment for Punch Set Change of Product
197. Quality Risk Assessment for Environmental Monitoring
198. Risk Assessment for Storage & Dispatch of Finished Goods
199. Risk Assessment of IPQC Isolator
200. Quality Risk Assessment for Dispensing of DPI
201. Quality Risk Assessment for Manufacturing of DPI
202. Quality Risk Assessment (DPI)
203. Risk Assessment for Wrong Batch Coding
204. Risk Assessment for Receipt and Storage of Bulk Material
205. Initial Risk Assessment of OGB
206. Risk Assessment for Cleaning and Sanitization of Equipment and Area
207. Risk Assessment for Tablet Inspection
208. Risk to product quality as inlet temperature fluctuation against set value in Auto coater
209. Risk Assessment for RLAF Cleaning Procedure
210. Risk Assessment for Similar looking product
211. Risk Assessment for Dry Syrup Bottle Cleaning machine
212. Risk Assessment for Equipment Handling
213. Risk Assessment for Dry Syrup Filling Machine and Area
214. Impact Assessment for Deviation in HPLC Calibration
215. Risk Assessment for Dry Powder Injection
216. Quality Risk Assessment for Coating Process of Levofloxacin 500 mg Tablets
217. Quality Risk Assessment Raniphir Injection 2 ml
218. Quality Risk Assessment Sampling (External Sampling)
219. Quality Risk Assessment for External Preparation 2
220. Quality Risk Assessment for Sampling (Liquid Injection)
221. Quality Risk Assessment Dispensing (Liquid Injection)
222. Quality Risk Assessment (Sampling DPI)
223. Risk Assessment document for HVAC System
224. Risk Assessment for Purified Water Generation & Distribution System
225. Risk Assessment for Entry & Exit With Common Change Rooms First Floor
226. Risk Assessment for Entry & Exit With Common Change Rooms for Second Floor
227. Risk Assessment for Elemental Impurities of Paracetamol 500 mg Tablet
228. Risk Assessment for Elemental Impurities of Allopurinol 300 mg Tablet
229. Risk Assessment for Entry & Exit with Common Change Rooms
230. Risk Assessment Product Processing of an Eye Drop
231. Risk Assessement for Environmental Monitoring
232. Risk Assessment for New Vendor Introduced
233. Risk Assessment for Bin Blender
234. Risk Assessment for Vibro Sifter
235. Risk Assessment for Sampling & Dispensing
237. Risk Assessment for Removal of Lower in Secondary Packing area
238. Protocol for Risk Assessment & Mitigation of Process Simulation Study
239. Report for Risk Assessment and Mitigation for Process Simulation Study
240. Protocol for Risk Assessment of Warehouse facility
241. Report of Risk Assessment of Warehouse Facility
242. Risk Assessment for Cone Mill
243. Risk Analysis for Process Preparation and 5-ALA Stage-1
244. Risk Assessment for Manufacturing Tanks
246. Risk Assessment for Containers used in Manufacturing Area
247. Risk Assessment for Paste Kettle
248. Risk Assessment for Dispensing, Sieving & Blending
249. Risk Assessment for Be-Coater
250. Risk Assessment for HVAC System
252. Risk Assessment for Extraneous Material in Tablets
253. Risk Analysis Study Protocol cum Report for reducing Testing of Rinse or Swab Samples
255. Risk Analysis Report for Discontinuation or Extension of Sampling Testing Frequency
256. Report for Risk Assessment and Mitigation for handling of Raw Material stored at below 25°C
257.Risk Assessment for Tablet Compression Machine
258. Quality Risk Assessment for Cross Contamination of Product in shared Manufacturing Facility
259.
thanks for the articles. really helpful
PLEASE SHARE CROSS CONTAMIANTION RISK ASSESSEMENT IN MICROBIOLOGY LABORATORY
Dear Sir,
Please contact through what app
Please share the performance qualification report for FPP machine
DEAR PLEASE CONTACT THROUGH WHATSAPP 6398636841
Please share the risk assessment for track and trace system software
contact through whatapps at site screen