Quality By Design- Fundamentals l Principles l Objectives l Applications (Part I) #qualitycontrol — Transcript

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1. 0:02Welcome to Simplify Pharma. Do subscribe
2. 0:04to my channel to stay updated with the
3. 0:06latest videos.
4. 0:11In this video, we will discuss the basic
5. 0:13concept of quality by design.
6. 0:15Why this concept was developed, what
7. 0:17does QBD mean, and how it is beneficial
8. 0:20for pharmaceutical industries.
9. 0:22An effort has been made to simplify it
10. 0:24for further understanding.
11. 0:28The basic concept of QBD is the quality
12. 0:31cannot be tested into the product, but
13. 0:33it should be built into it. And this
14. 0:35concept was first outlined by Joseph M.
15. 0:38Juran.
16. 0:40He believed that quality could be
17. 0:41planned, and that most quality crises
18. 0:44and problems they relate to the way in
19. 0:46which quality was planned in the first
20. 0:48place.
21. 0:49According to Joseph Juran, quality is
22. 0:52planned into the product from the very
23. 0:54first stage of designing the product,
24. 0:56and like this at each and every stage.
25. 0:59Only then we can build quality into the
26. 1:01product.
27. 1:05Pharmaceutical industry is constantly
28. 1:07searching the ways to ensure and enhance
29. 1:10product safety, quality, and efficacy.
30. 1:14However, manufacturing failure cost,
31. 1:17scale-up issues,
32. 1:20regulatory burden,
33. 1:22and drug recalls in recent past, they
34. 1:24have posed huge challenge for the
35. 1:26industry.
36. 1:28This is the reason
37. 1:29the pharmaceutical industry has
38. 1:31undergone a paradigm shift from
39. 1:33traditional quality by testing to the
40. 1:35systematic quality by design approach.
41. 1:38And this is to attain efficient product
42. 1:41development,
43. 1:42and that to the products that are
44. 1:43cost-effective with enhanced quality.
45. 1:49In traditional approach, end product
46. 1:52testing is used predominantly to ensure
47. 1:55the product quality
48. 1:56and product performance with limited
49. 1:59understanding of the product and process
50. 2:01parameters and critical process
51. 2:03parameters.
52. 2:04In the current scenario of regulatory
53. 2:06environments, the pharmaceutical
54. 2:08industry is continuously facing
55. 2:10challenges with respect to achieving the
56. 2:12desired quality of drug product.
57. 2:15Two major issues highlighted over the
58. 2:17years, they include
59. 2:20poor
60. 2:21GMP compliance, and lack of
61. 2:23understanding regarding the product and
62. 2:25process parameters.
63. 2:28Regulatory bodies are therefore focusing
64. 2:31on implementing quality by design, that
65. 2:34is a science-based approach. It improves
66. 2:36the process understanding by reducing
67. 2:39the process variation and enabling the
68. 2:42process control strategies.
69. 2:44Now, instead of relying on finished
70. 2:46product testing alone like traditional
71. 2:48approach,
72. 2:50QBD provides insights throughout the
73. 2:53development process.
74. 2:54That means in QBD planning,
75. 2:58in QBD planning is done from the very
76. 3:00first stage of designing the product,
77. 3:02and it goes on for each and every
78. 3:04development stage. As a result, a
79. 3:07quality issue can be efficiently
80. 3:09analyzed, and once we have analyzed the
81. 3:12reason for the default in quality,
82. 3:15the root cause can be quickly
83. 3:18identified.
84. 3:22QBD entered the pharmaceutical industry
85. 3:24quite late in 2004, when US FDA took
86. 3:28initiative for improving the standards
87. 3:30of pharmaceutical manufacturing.
88. 3:33FDA's emphasis on QBD began with the
89. 3:36recognition that increased testing does
90. 3:38not necessarily improve product quality,
91. 3:41whereas the quality must be built into
92. 3:44the product.
93. 3:46FDA announced certain amendments to the
94. 3:49CGMP in 2002 with an emphasis on
95. 3:53establishing
96. 3:5421st century outlook on pharma
97. 3:56manufacturing.
98. 3:58So, what was the goal over there? To
99. 3:59establish a more systematic science and
100. 4:02risk-based approach to the development
101. 4:04of pharmaceutical products.
102. 4:08In an initiative in July 2003, the ICH
103. 4:11instituted various regulatory guidances
104. 4:14like Q8, Q9, Q10, and set forth the
105. 4:17concept of quality by design as a
106. 4:20holistic approach which delivers high
107. 4:23quality, robust drug products.
108. 4:27With QBD around, the predefined
109. 4:29objectives of the target quality, they
110. 4:32enable the zero quality defect and avoid
111. 4:35quality crisis.
112. 4:38QBD means planning quality into the
113. 4:41product.
114. 4:43QBD facilitates improvement in quality
115. 4:46by thoughtful planning
116. 4:48and meaningful execution.
117. 4:50Hence, QBD is also called quality by
118. 4:52planning, but not by chance.
119. 4:58QBD ensures predefined product quality
120. 5:00objectives by means of designing and
121. 5:03developing
122. 5:04formulations and manufacturing
123. 5:06processes.
124. 5:09QBD begins with predefined objective
125. 5:12and emphasizes on product and process
126. 5:14understanding and process control.
127. 5:17In order to initiate a successful QBD
128. 5:19program, the first step
129. 5:21is to identify those product and process
130. 5:24parameters that are essential
131. 5:27for the product quality.
132. 5:31And then develop well-validated
133. 5:33analytical methods to monitor those
134. 5:35parameters.
135. 5:40Use of sound scientific principles and
136. 5:43quality risk management, these are the
137. 5:45two key enablers of QBD philosophy,
138. 5:48which provides enhanced product and
139. 5:51process understanding on the target drug
140. 5:53product.
141. 5:54Based on these principles, QBD delivers
142. 5:57enormous benefits, manufacturing and
143. 5:59business benefits.
144. 6:03QBD can ensure a safe and effective drug
145. 6:06supply
146. 6:07while also significantly improving the
147. 6:09quality of manufacturing performance.
148. 6:12It has become a new concept for
149. 6:14development of quality pharmaceutical
150. 6:15products.
151. 6:18Therefore, QBD is all about using
152. 6:20scientific knowledge for product and
153. 6:22process understanding,
154. 6:24thus designing a product and process
155. 6:26control in such a manner to achieve high
156. 6:29quality product.
157. 6:31Now, this is a comparative table that
158. 6:33explains in depth how QBD differs from
159. 6:36traditional process.
160. 6:37In traditional approach, it starts with
161. 6:39trial and error, whereas QBD is
162. 6:42completely planned. It starts with a
163. 6:45predefined objective.
164. 6:47Traditional, the quality is assured by
165. 6:49end product testing and inspection.
166. 6:52Whereas in QBD, the quality is built in
167. 6:55the into the product and process by
168. 6:57designing.
169. 6:58In traditional,
170. 7:00it is a very rigid process. It
171. 7:01discourage any kind of changes. QBD on
172. 7:04the other hand is a very flexible
173. 7:06process. It allows continuous
174. 7:08improvement.
175. 7:10Traditional, it focuses on
176. 7:12reproducibility.
177. 7:13It often ignores or avoids variation.
178. 7:17QBD, it focuses on robustness, that
179. 7:19means more quality, understanding and
180. 7:22controlling variation.
181. 7:25Traditional, there is a limited
182. 7:26understanding of process or critical
183. 7:28process parameters. QBD, it emphasizes
184. 7:32on product and process understanding
185. 7:33using scientific knowledge.
186. 7:37So, QBD approach, it has several
187. 7:39benefits to the industry like better
188. 7:41understanding of the process.
189. 7:43It minimize the deviations, less batch
190. 7:45failure,
191. 7:47more efficient and effective control of
192. 7:49change.
193. 7:50Thus, we can avoid the regulatory
194. 7:51compliance problem, increase the
195. 7:54manufacturing efficiency, and that leads
196. 7:57to more cost saving, cost-effective, and
197. 8:00more quality products.
198. 8:02Additional benefits in they include such
199. 8:05as reduction of post-approval
200. 8:06submissions,
201. 8:08more efficient technology transfer to
202. 8:09the manufacturing,
203. 8:11innovative process validation
204. 8:13approaches,
205. 8:14quality risk assessment and management,
206. 8:17and reduced end product testing.
207. 8:20Several QBD applications are like drug
208. 8:23substance development, analytical
209. 8:25development, formulation development,
210. 8:28pharmaceutical manufacturing,
211. 8:30bioequivalence studies, and clinical
212. 8:32trials. Thus, QBD is a very important
213. 8:36tool when it comes to pharmaceutical
214. 8:37industries and good product, that is
215. 8:40quality product manufacturing.
216. 8:43If you like the video, do
217. 8:47do like and subscribe my channel.
218. 8:49Thank you.