WEBVTT

1
00:00:00.000 --> 00:00:01.621
Welcome to Module 2.

2
00:00:01.771 --> 00:00:06.187
Our fictional project is a jacketed mixing
vessel used to prepare an

3
00:00:06.337 --> 00:00:08.791
aqueous oral solution before filling.

4
00:00:08.941 --> 00:00:10.967
It is not an aseptic process.

5
00:00:11.117 --> 00:00:14.616
We will follow the project from planning
to a review decision.

6
00:00:14.766 --> 00:00:18.926
Begin by asking what product the system
supports, how it will be used,

7
00:00:19.076 --> 00:00:20.399
and what could go wrong.

8
00:00:20.549 --> 00:00:24.261
A polished protocol cannot rescue an
undefined purpose.

9
00:00:25.011 --> 00:00:28.189
The validation master plan describes the
programme.

10
00:00:28.339 --> 00:00:32.905
The user requirements specification
describes what the system must do.

11
00:00:33.055 --> 00:00:37.279
The risk assessment explains where
failures matter and how controls will

12
00:00:37.429 --> 00:00:38.623
be justified.

13
00:00:38.773 --> 00:00:41.717
In this course we say VMP and URS.

14
00:00:41.867 --> 00:00:44.413
These documents should agree with one
another.

15
00:00:44.563 --> 00:00:47.785
If the vessel needs controlled mixing, the
requirement,

16
00:00:47.935 --> 00:00:52.223
risk discussion and verification evidence
should all address that need.

17
00:00:52.973 --> 00:00:57.346
Imagine buying a vessel because the
catalogue says pharmaceutical grade.

18
00:00:57.496 --> 00:01:00.952
That description does not establish
fitness for our product.

19
00:01:01.102 --> 00:01:04.878
The team still needs to understand contact
materials, cleaning,

20
00:01:05.028 --> 00:01:07.012
measurement, mixing and records.

21
00:01:07.162 --> 00:01:11.514
The illustration connects a product vessel
to its temperature sensor and

22
00:01:11.664 --> 00:01:12.773
control panel.

23
00:01:12.923 --> 00:01:16.529
These are functional interfaces, not a
construction drawing.

24
00:01:16.679 --> 00:01:22.247
The same intended use must guide design
review, testing and routine operation.

25
00:01:22.997 --> 00:01:28.392
For the first activity, describe the
vessel's intended use in three sentences.

26
00:01:28.543 --> 00:01:33.300
Identify the product family, operating
purpose and important interfaces.

27
00:01:33.450 --> 00:01:35.989
Then list information that is still
missing.

28
00:01:36.139 --> 00:01:39.232
Do not invent operating limits to complete
a form.

29
00:01:39.382 --> 00:01:42.283
Assign each missing item to an appropriate
owner,

30
00:01:42.433 --> 00:01:45.036
such as process development or
engineering.

31
00:01:45.186 --> 00:01:49.730
Planning is useful when it exposes
uncertainty early enough to change the

32
00:01:49.880 --> 00:01:50.968
project.