QbD Quality by Design-6 Sages- Part II #Quality Assurance — Transcript

Full transcript

1. 0:01Welcome to simplify Pharma. First of
2. 0:03all, I want to thank all my viewers for
3. 0:06the overwhelming response in quality by
4. 0:09design part one video. And this is a
5. 0:11reason I have come with quality by
6. 0:13design part two
7. 0:15of that video in which we will discuss
8. 0:18various steps that are involved in
9. 0:19quality by design.
10. 0:22In the previous video, we saw the
11. 0:24principles of QbD in which
12. 0:28it was QbD means planning quality into
13. 0:31the product. That's why we say it
14. 0:33quality by plan and not by chance.
15. 0:37QbD facilitates improvement in quality
16. 0:39by thoughtful planning and meaningful
17. 0:41execution.
18. 0:43That's why we can say the objective of
19. 0:45QbD
20. 0:46the main objective is to achieve quality
21. 0:50product.
22. 0:51QbD is based on how materials and
23. 0:53process parameters they affect quality
24. 0:55profile of final product.
25. 0:58Now the applications of QbD
26. 1:01if used properly a QbD approach can help
27. 1:05address issues early in the product
28. 1:08development process and prevent failures
29. 1:11at an advanced state of development.
30. 1:14Nowadays, if you'll see uh especially in
31. 1:17pharmaceutical industries they no longer
32. 1:20can carry out any project without taking
33. 1:23into consideration
34. 1:25the ICH guidelines and since QbD is a
35. 1:28part of ICH guidelines, that's why the
36. 1:30pharmaceutical industry nowadays they
37. 1:32have to follow QbD approach.
38. 1:35The application of QbD
39. 1:38in product design and process design it
40. 1:41is based on good understanding of
41. 1:44sources of variability
42. 1:46and manufacturing process.
43. 1:49The QbD is based on materials and
44. 1:52process parameters and how they affect
45. 1:55the quality of the final product.
46. 1:59Here we can see different steps involved
47. 2:01in QbD.
48. 2:02There are six different steps that are
49. 2:04involved in QbD.
50. 2:06Defining the product profile that in
51. 2:09involves defining the TPP and QTPP. TPP
52. 2:14is target product profile and QTPP is
53. 2:18quality target product profile. This is
54. 2:21the step one.
55. 2:22Then step two is to identify critical
56. 2:25quality attributes.
57. 2:28Then step three is to carry out risk
58. 2:31assessment.
59. 2:33After that, once we have carried out a
60. 2:35risk assessment, we can determine the
61. 2:38critical material attributes and
62. 2:41critical process parameters. On that
63. 2:43basis, we can establish a design space
64. 2:46and describe control strategy with which
65. 2:50constitutes of using statistical process
66. 2:53control.
67. 2:55And then the last step is the continuous
68. 2:58improvement. It's like a life cycle
69. 3:00management. So this is overall a
70. 3:03continuous process.
71. 3:05These six steps you have to keep in mind
72. 3:07if you have to understand QbD more in
73. 3:10detail.
74. 3:11In next
75. 3:13video, I will cover different stages of
76. 3:16QbD in detail.
77. 3:19Now if you remember in our previous
78. 3:20video we saw QbD begins with predefined
79. 3:24objectives and emphasizes on product and
80. 3:28process understanding
81. 3:30and process control. In order to
82. 3:32initiate a successful QbD program, the
83. 3:35first step is to identify those process
84. 3:37parameters that are essential to product
85. 3:40quality and develop well validated
86. 3:43analytical methods to monitor those
87. 3:46parameters.
88. 3:48Now in similar manner
89. 3:50if we take a look at the steps of QbD
90. 3:53uh the as we saw them previously, now on
91. 3:57the basis of product understanding and
92. 3:59process understanding, we can see the
93. 4:01first two steps of QbD they are more
94. 4:04about product understanding whereas the
95. 4:07third and fourth step is more about
96. 4:10process understanding.
97. 4:11And the control strategy, it is mainly
98. 4:14of two types, process control strategy
99. 4:16and analytical control strategy.
100. 4:20Let us see these steps in detail
101. 4:23on the basis of product understanding
102. 4:24and process understanding.
103. 4:27Now the step one, that is to define
104. 4:29product profile, TPP and QTPP. That is
105. 4:33target product profile and quality
106. 4:35target product profile.
107. 4:38When we say to define a product profile,
108. 4:41that is to define desired quality
109. 4:44character characteristics of the
110. 4:46product. Let's take a simple example.
111. 4:49For example, we want to buy a mobile
112. 4:51phone.
113. 4:52So for that mobile phone, before buying
114. 4:54that mobile phone, we have to understand
115. 4:57what are the desired characteristics
116. 4:59that we require in the mobile phone. For
117. 5:01example, the screen should be 6.5
118. 5:05uh inches long. Then the camera should
119. 5:08be minimum 60 megapixel.
120. 5:11Then the RAM, the internal memory space
121. 5:15all these things they are the
122. 5:17characteristics of the mobile phone. In
123. 5:19the similar manner, if we have to uh
124. 5:23design a product, we have to define the
125. 5:26desired quality characteristics that we
126. 5:28want in that in that pharmaceutical
127. 5:31product.
128. 5:32Step two, that is again understanding
129. 5:35the product is identify critical quality
130. 5:39attributes.
131. 5:41Once you have identified the TPP or QTPP
132. 5:45on the basis of QTPP, we can identify
133. 5:48the critical quality attributes. Now
134. 5:51again, we will take the simple example
135. 5:53of uh buying the mobile phone. Now once
136. 5:56we have written down all the qualities
137. 5:58that we want in the mobile that we want
138. 6:00to buy. Now out of that, if we say that
139. 6:03there are two qualities that I must want
140. 6:06in in that mobile phone before
141. 6:08purchasing. For example, camera, it
142. 6:10should be 60 megapixel and RAM should be
143. 6:1416 GB. Without these two qualities, I
144. 6:17will not buy the mobile phone. So these
145. 6:19two qualities are the critical quality
146. 6:22attributes. That means these two
147. 6:24qualities will determine how my mobile
148. 6:27will function, will it meet my
149. 6:28requirements or not. In the similar
150. 6:31manner in pharmaceutical industry
151. 6:33critical quality attributes. That means
152. 6:36once you have defined the QTPP, that is
153. 6:40quality target product profile, it is
154. 6:42like A to Z of the product, all the
155. 6:45information. Now out of all those
156. 6:47information, the important ones we have
157. 6:50to identify. The important ones comes
158. 6:52under critical quality attributes.
159. 6:57So what all comes under critical quality
160. 6:59attributes like the properties of the
161. 7:01finished product, physical, chemical,
162. 7:03biological, or microbiological.
163. 7:07Now we will come to the process
164. 7:09understanding steps. Now in order to
165. 7:11understand the process, what all we need
166. 7:13to identify? We need to identify process
167. 7:16performance indicators, critical
168. 7:18material attributes, critical process
169. 7:21parameters, process characterization
170. 7:24and all this why are we doing?
171. 7:26It helps to study the impact of if there
172. 7:29are any variations in the process
173. 7:30parameters or raw materials
174. 7:32on proposed CQAs. So and we can
175. 7:35determine the process parameter and raw
176. 7:37material criticality.
177. 7:39So in case of any variations, we can
178. 7:42determine what are the different process
179. 7:45parameters, critical process parameters,
180. 7:47or critical raw material.
181. 7:50So this all indicators they help us to
182. 7:53determine the critical process
183. 7:55parameters. Only then we can understand
184. 7:57the process.
185. 7:59Coming to the next part, that is the
186. 8:01control strategy. There are two types of
187. 8:04control strategies, process control
188. 8:06strategy and analytical control
189. 8:08strategy. So derived these both are
190. 8:11derived based on understanding and
191. 8:13control of sources of variability.
192. 8:16So in um previous stages we saw we have
193. 8:19to determine what are the various
194. 8:20sources of variability. In the next step
195. 8:23is we are trying to control those
196. 8:25sources of variability. Only then we can
197. 8:27ensure the product quality as well as
198. 8:29consistency.
199. 8:30Therefore, for execution of QbD, those
200. 8:33six steps, if you see, they are divided
201. 8:35mainly in under three main branches,
202. 8:37that is product understanding, process
203. 8:39understanding, and control strategy. So
204. 8:43through this we can understand the six
205. 8:45steps of QbD. In my next video, stay
206. 8:49tuned. I'll describe all the six stages
207. 8:51in detail so that it will give a proper
208. 8:54understanding of the QbD approach. Thank
209. 8:58you for watching my videos and stay
210. 9:00tuned.