Quality Risk Assessment #QbD #Quality by Design Part 6 — Transcript

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1. 0:01welcome to simplify farmer in this
2. 0:04lecture we will discuss the tools of
3. 0:06quality by Design and how are they
4. 0:09useful in pharmaceutical
5. 0:11Industries there are three tools qbd
6. 0:15tools that are used in pharmaceutical
7. 0:17industry design of experiment doe risk
8. 0:20assessment and process analytical
9. 0:23technology
10. 0:25P now we will discuss risk assessment in
11. 0:28detail in this lecture if you remember
12. 0:32we were talking about different stages
13. 0:34or steps in qbd and amongst that the
14. 0:38third step was risk assessment the
15. 0:40earlier steps we have already covered in
16. 0:42our previous lectures you can refer to
17. 0:44those videos risk assessment it is
18. 0:47defined as combination of probability of
19. 0:50occurrence of harm and severity of that
20. 0:54harm probability of occurrence of harm
21. 0:58if that harm can occur or or not and if
22. 1:01it occurs what is the severity of harm
23. 1:04this is called as risk assessment it
24. 1:07helps to increase quality of method or
25. 1:11process now risk assessment it consists
26. 1:14of identification of Hazard then
27. 1:18analysis of risk associated with these
28. 1:21hazards and evaluation of risk
29. 1:23associated with the
30. 1:25hazards let's take an example to
31. 1:28understand this in analytical method
32. 1:31development small changes in methods
33. 1:34like a reagent or instrument analys lab
34. 1:39days temperature humidity they all are
35. 1:42included in risk assessment why because
36. 1:46any small change it can cause a big
37. 1:51impact uh the principle of quality risk
38. 1:54management it says scientific knowledge
39. 1:58based evaluation of the risk we are
40. 2:01evaluating the risk based on some data
41. 2:04for quality which eventually links to
42. 2:07the protection of the patient so main
43. 2:09aim that we have in our mind is overall
44. 2:13protection of the patient safety and
45. 2:16efficacy we have to keep in mind while
46. 2:18assessing the risk the initial list of
47. 2:22potential parameters that can affect
48. 2:24cqas it is usually very long very
49. 2:28extensive but we can reduce that list if
50. 2:31we use quality risk assessment it is
51. 2:35commonly understood that risk is defined
52. 2:37as combination of probability of
53. 2:39occurrence of harm and the severity of
54. 2:42that harm then risk assessment helps to
55. 2:45increase quality of method or
56. 2:48process also it is determinant for
57. 2:51effect of input variable on method or
58. 2:55process from risk assessment one can
59. 2:58recognize critical quality attributes
60. 3:00that are going to affect the final
61. 3:02quality of the product so this is a
62. 3:06reason we use risk
63. 3:09assessment we need to understand the
64. 3:12relationship between risk and
65. 3:14criticality in order to understand how
66. 3:17to assess the risk risk includes three
67. 3:21things that we have to always remember
68. 3:24severity of harm probability of
69. 3:27occurrence and
70. 3:28detectability how SE is the harm and
71. 3:32what is the probability it will occur
72. 3:35and if it occurs can we detect it so
73. 3:38these are the three main pillars how we
74. 3:41assess the risk therefore the level of
75. 3:44risk can change as a result of risk
76. 3:47management if we detect the risk and
77. 3:50somehow reduce its probability obviously
78. 3:53the level of risk will
79. 3:56change now if we talk about cqa and CP P
80. 4:00there are things a bit different cqa is
81. 4:04primarily based upon severity of the
82. 4:06harm if you remember how severe the harm
83. 4:09will be based upon that we pick up the
84. 4:12critical quality attributes therefore it
85. 4:14does not change as a result of risk
86. 4:18management whereas CPP it is linked to
87. 4:21parameters effect on cqa so if we change
88. 4:24those
89. 4:25parameters then you know any critical
90. 4:28potential parameter process parameter
91. 4:32that we can change so it is based upon
92. 4:35probability of occurrence and
93. 4:37detectability therefore CPP it can
94. 4:40change as a result of risk management
95. 4:43risk assessment is used in product
96. 4:47development to identify relative risk
97. 4:50levels at the beginning of product
98. 4:53development to prioritize The Limited
99. 4:55development resources we all are aware
100. 4:58when it comes to Pharmaceutical industry
101. 5:00the resources money
102. 5:04Manpower time all these things they are
103. 5:08you know very limited so we need to
104. 5:10prioritize whatever we are
105. 5:13using to document the decision making
106. 5:16process throughout the
107. 5:18development to assess the needs of
108. 5:20additional studies for scaleup and
109. 5:22Technology transfer to identify
110. 5:25appropriate specification critical
111. 5:27process parameters manufacture
112. 5:30control and to reduce any variation in
113. 5:34critical quality attributes so this is
114. 5:37how risk assessment help us in
115. 5:38pharmaceutical
116. 5:40industry the various steps involved in
117. 5:43risk assessment are first of all we need
118. 5:46to list out all the components or
119. 5:48processes then we need to prepare the
120. 5:51process flow
121. 5:53chart upon preparing the process flow
122. 5:56chart we have to identify what might go
123. 5:59wrong wrong so this is called as risk
124. 6:03identification then we have to determine
125. 6:06what is the likelihood that's why we say
126. 6:08probability that it will go WR this is
127. 6:11called as risk
128. 6:13analysis then the step comes what are
129. 6:16the consequences first we have to
130. 6:17determine what might go wrong what is
131. 6:19the
132. 6:20likelihood it will go wrong then what
133. 6:23are the consequences that is called a
134. 6:25severity and this comes under risk
135. 6:28evaluation so the these are the steps
136. 6:30for risk
137. 6:31assessment then let's take a look at the
138. 6:34methods that are used for risk
139. 6:36assessment the failure mode effects
140. 6:39analysis which is called as
141. 6:41FMEA failure mode effects and
142. 6:43criticality
143. 6:45Analysis faultry analysis preliminary
144. 6:49Hazard analysis let's see in our nut
145. 6:52what does all these methods are used for
146. 6:56failure mode effects analysis break down
147. 6:59large complex process into manageable
148. 7:02steps then
149. 7:04FMEA
150. 7:06FMEA it is you know a more advanced
151. 7:09version of FMEA so
152. 7:12FMEA is used and along with that if we
153. 7:15link sity probability and detectability
154. 7:18to criticality it becomes FM
155. 7:21ECA then faultry analysis it is a tree
156. 7:24of failure modes combinations with
157. 7:27logical operators preliminary Hazard
158. 7:31analysis it is the possibilities that
159. 7:33the risk event happens Hazard and
160. 7:37operability
161. 7:39Analysis Hazard analysis and critical
162. 7:42control
163. 7:43points risk ranking and
164. 7:45filtering and statistical tools let's
165. 7:48take a look how these methods are
166. 7:52useful the H zop it is used because it's
167. 7:56a brainstorming technique then H CCP
168. 8:00systematic proactive and preventive
169. 8:02method on
170. 8:03criticality risk ranking and filtering
171. 8:06it compare and prioritize risk with
172. 8:08factors for each risk and the
173. 8:11statistical Tools in which we use
174. 8:13control charts and design of experiments
175. 8:16so these are the different methods that
176. 8:18are used for risk
177. 8:20assessment coming to the next part of
178. 8:22our lecture that is risk ranking and
179. 8:24filtering we need to understand this
180. 8:27only then we will be able to assess the
181. 8:29RIS risk the first step in Risk ranking
182. 8:32and filtering is potential risk are
183. 8:35identified then the then their
184. 8:37probability of occurrence is
185. 8:40estimated then on that basis the
186. 8:42severity of the harm is
187. 8:45estimated then each individual risk is
188. 8:48assigned a specific score based on the
189. 8:50probability and sity and based on this
190. 8:53score the overall score is determined
191. 8:55for each identified potential risk then
192. 8:59the risk are ranked and filtered using a
193. 9:02criteria specific to the circumstances I
194. 9:05know this is very theoretical let us
195. 9:06explain it with the help of case
196. 9:10studies this is how we uh Rank and
197. 9:13filter the risk if you can see over here
198. 9:17uh on this basis probability and
199. 9:19severity the number is given then this
200. 9:22is a risk ranking 1 to2 is low risk 3 to
201. 9:264 medium more than six is high
202. 9:30and if it is low broadly accepted risk
203. 9:34no further investigation is required if
204. 9:36it is medium risk is accepted though but
205. 9:40further investigation may be needed to
206. 9:43reduce the risk if it is high risk is
207. 9:46unacceptable and further investigation
208. 9:49is required you need to take more steps
209. 9:51in order to reduce the
210. 9:53risk so we need to understand that qbt
211. 9:57it begins with RIS risk
212. 10:00identification starting with high risk
213. 10:02quality attributes and process
214. 10:04parameters the development team carry
215. 10:07out design space study So based on these
216. 10:10results from these studies and research
217. 10:12that is prior knowledge literature
218. 10:13review clinical data the development
219. 10:16team it can go back to the initial risk
220. 10:20assessment and update the Risk
221. 10:22Index risk assessment should be updated
222. 10:25at every step of product development
223. 10:27life cycle before submitting a dose here
224. 10:30we must try to reduce the number of
225. 10:31highrisk items because if we leave any
226. 10:36point or any risk that is unresolved by
227. 10:38the time of submitting that dose here
228. 10:41then in that case you know the uh
229. 10:43regulatory authorities they can raise a
230. 10:46question mark and control strategy IT
231. 10:49addresses how we will manage them so in
232. 10:54this diagram if you'll see risk
233. 10:56assessment is used at each and every
234. 10:58stage throughout the development of life
235. 11:00cycle this is the reason risk assessment
236. 11:02is very important part of quality by
237. 11:06Design this is uh one case study that I
238. 11:09have pulled from the internet this is
239. 11:12the quality by Design example that the
240. 11:15FDA has given on their website for the
241. 11:17immediate release dosage form I will
242. 11:20give a link to this PDF file in the
243. 11:23description box download this PDF file
244. 11:25in this PDF file all the steps of qbd
245. 11:28Within example they took they have taken
246. 11:30one immediate release dosage from uh
247. 11:33aspon and using that example they have
248. 11:36explain all the steps of quality by
249. 11:38Design This is you can find on the usfda
250. 11:41website so this one case study if you
251. 11:44want me to explain this PDF in detail
252. 11:48you have to again leave the comments in
253. 11:50the comment box any other video that you
254. 11:54feel you want explanation you want a
255. 11:56lecture on that please leave coms in the
256. 11:59comment
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261. 12:11videos thank you thank you for watching