Part 2 of the Day: Training Session of Pharmaceutical Manufacturing Professionals conducted at Karachi

1. Documentation
The First & Last Exit in GMP
02 Nov 2019, Karachi
Policies & Procedures

3. 2 Policies and Procedures

4. Policies
• Documents used to influence and dictate
actions / decisions
• Broad in scope and affect typically
different organizational/ business/
geographical units
• Describes requirements but NOT
specifics on how to accomplish tasks

5. Policies
Directions reflecting vision
……Where to go ……
How to go? …
How to execute? …
How to move ? …
What not to do? …

6. Procedure
Set of instructions that describes a
task or process.
A specified way to perform an activity

7. Instructions
The specific, detailed requirements
for performing a particular task

8. Policy Procedure Instruction
Governance

9. Consistent Construct Continuous
What, Why and How

10. Consistent Construct Continuous
Clear CompleteCorrect

11. Question
You have a Cleaning Policy in place but don’t
have a procedure to execute for cleaning of
water tank inside GMP zone
It is outsourced & performed by 3rd party, you
are unaware about the procedure of cleaning
used by them.
What is your point of view? Explain please
5

12. Question
If a mixer is run for 15 minutes, it
mixes the materials because it is
repeated 3 times and validated,
So there is no need for
in-process tests
6

13. Workshop
Write instruction how to clean a pipe
piece used in filling of water in
manufacturing unit
Write instructions to hang a wall
clock, adjust its time, change of its
battery periodically, and its
monitoring
OR

14. Workshop
What others aspects should be
included in SOP other than
instructions

15. Workshop
How to write
• Concept …begin with the end in mind
• Select a format (approved)
• Collect the inputs
• Define scope
• Identify the audience
• Write SOP
• Send for review
• Answer the questions
• Get it authorized

16. Workshop
Write Cleaning Policy
(An outline)
• Statement
• Principle, values, philosophy
• Detail objectives
• Strategy to achieve objectives
• Specific actions when required
• Desired outcome of specific actions
• Performance indicators
• Review program

17. Thank You