2 - GMP June 2022 - CQS.pdf

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The document discusses the importance of good manufacturing practices (GMP) in ensuring drug quality and safety. It emphasizes that GMP provides documentation, traceability, trust, and predictability to assure the identity, quality, strength and correct manufacturing of drugs. While testing can verify quality, building quality into the manufacturing process through adherence to GMP is even more important. Ongoing monitoring processes like surveillance, complaint handling and recalls are also needed to protect patients even after a batch passes testing. Non-compliance with GMP can lead to disasters like mix-ups and contamination that endanger public health.

Connecting Dots &
Creating Big Picture
to Focus

GMP for Quality &
Quality for Life
Ignorance brings Disaster
Compliance is not
Choice but Obligation
Confusion Promotes Mix up
& Mix up is nothing but
Disaster
1
2
4
5
Humans Contaminate
Drugs
Feel smoke before it
appears
3 6
Connect dots & create a big picture to focus

GMP for Quality &
Quality for Life
1
Removing Fog to Enhance Clarity

GMP for Quality &
Quality for Life
1
Respect its claim
Perform as committed
Deliver benefits
Protects hope
Removing Fog to Enhance Clarity

Compliance is not
Choice but Obligation
2
Removing Fog to Enhance Clarity

Compliance is not
Choice but Obligation
2
Health is a constitutional right
Law and rules
Removing Fog to Enhance Clarity

Compliance is not
Choice but Obligation
2
Health is a constitutional right
Law and rules
Penalty and criminal proceedings
Removing Fog to Enhance Clarity

Compliance is not
Choice but Obligation
2
Drug manufactured under non-
GMP environment is an adulterated
drug and subject to penalty &
criminal proceedings
Health is a constitutional right
Law and rules
Penalty and criminal proceedings
Removing Fog to Enhance Clarity

Humans Contaminate
Drugs
3
Removing Fog to Enhance Clarity

Humans Contaminate
Drugs
3
Training & Professional Development
Removing Fog to Enhance Clarity

Humans Contaminate
Drugs
3
Skill, knowledge, ability, aptitude,
experience
Shed particles from skin, hair, clothes
Become source of microbial load
Ignorance, negligence, omission,
commission
Training & Professional Development
Removing Fog to Enhance Clarity

Ignorance brings Disaster
4
Removing Fog to Enhance Clarity

Ignorance brings Disaster
4
Mix up
Contaminated
Fail to deliver
Loss of potency
Etc. etc.
Removing Fog to Enhance Clarity

Confusion Promotes Mix up
& Mix up is nothing but
Disaster
5
Removing Fog to Enhance Clarity

Confusion Promotes Mix up
& Mix up is nothing but
Disaster
5
Physically safe and secure is the requirement
Removing Fog to Enhance Clarity

Confusion Promotes Mix up
& Mix up is nothing but
Disaster
5
Physically safe and secure is the requirement
Dedicated flow and movement control
Removing Fog to Enhance Clarity

Confusion Promotes Mix up
& Mix up is nothing but
Disaster
5
Free flowing
Heavy traffic
Crossing lines
Insecure and unsafe
Unattended
Physically safe and secure is the requirement
Dedicated flow and movement control
Removing Fog to Enhance Clarity

Feel smoke before it
appears
6
Removing Fog to Enhance Clarity

Feel smoke before it
appears
6
Improve certainty and protect quality
Removing Fog to Enhance Clarity

Feel smoke before it
appears
6
From reactive to preventive &
from preventive to predictive
Improve certainty and protect quality
Removing Fog to Enhance Clarity

Regulatory Methodology to
inspect manufacturing practices
of drugs is called

Good Manufacturing Practices
Regulatory Methodology to
inspect manufacturing practices
of drugs is called

Integrity & Quality
of manufactured products
for human use is protected by

Good Manufacturing Practices
Integrity & Quality
of manufactured products
for human use is protected by

Production & Control of
consistent products is ensured by

Good Manufacturing Practices
Production & Control of
consistent products is ensured by

• Documentation
• Traceability
• Trust
• Predictability
is provided by

Good Manufacturing Practices
• Documentation
• Traceability
• Trust
• Predictability
is provided by

• Identity, quality & strength of drugs
• Correct procedures are followed
• Timely documented
• Reviewed before release
is assured by

Good Manufacturing Practices
• Identity, quality & strength of drugs
• Correct procedures are followed
• Timely documented
• Reviewed before release
is assured by

Quality cannot be observed by every one and/or by naked eye
Quality cannot be tested in a laboratory but has to be built in to the product
We know
We know

If a drug is manufactured in GMP
environment & qualifies all tests,
Is it sufficient for quality or something
remains?

Surveillance
Complaints
Recalls
Vigilance

Pure
Consistent
Zero Mix
Up
DRUG
1 2 3
Batch after Batch
Within Batch
Time after Time

Doctor does not want to kill patient,
pilot does not want crash ….
But it happens sometime

Batch manufactured ……..
Testing completed …..
Batch history reviewed …………
But
Temperature recording of room was
found out of limit when batch was
manufactured
Can the batch be
released?

This presentation discusses creating a sustainable culture of quality in the pharmaceutical industry. It covers topics such as what good manufacturing practices (GMP) are and how they help ensure drug quality and safety. The presentation notes several past drug contamination incidents that harmed or killed patients. It emphasizes that quality cannot be tested into products but must be built into the manufacturing process. The presentation also discusses quality culture and attributes like leadership, continuous improvement, and understanding human behavior and motivations. The overall message is that a robust quality system and culture are needed to avoid quality issues and protect patients.

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Based on the scenario provided, here are the key steps I would recommend the finished goods manufacturer take: 1. Immediately notify the relevant regulatory authorities of the potential contamination issue and put all affected batches of finished product on hold. 2. Conduct a thorough investigation to determine the extent of contamination and identify which batches of API and finished product may be impacted. This should include testing retained samples. 3. Recall all affected batches of finished product that may contain terazosin contamination from the supply chain and inform customers. 4. Develop and implement a risk mitigation and communication plan to address potential safety issues and prevent further distribution of contaminated product. 5. Review manufacturing and quality control processes to identify any gaps that allowed

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Healthy economic development requires properly managing the banking industry of any country. Along with state-owned banks, private banks play a critical role in the country's economy. Managers in all types of banks now confront the same challenge: how to get the utmost output from their employees. Therefore, Performance appraisal appears to be inevitable since it set the standard for comparing actual performance to established objectives and recommending practical solutions that help the organization achieve sustainable growth. Therefore, the purpose of this research is to determine the effect of performance appraisal on employee motivation and retention.

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2 - GMP June 2022 - CQS.pdf

1. Connecting Dots & Creating Big Picture to Focus

2. GMP for Quality & Quality for Life Ignorance brings Disaster Compliance is not Choice but Obligation Confusion Promotes Mix up & Mix up is nothing but Disaster 1 2 4 5 Humans Contaminate Drugs Feel smoke before it appears 3 6 Connect dots & create a big picture to focus

3. GMP for Quality & Quality for Life 1 Removing Fog to Enhance Clarity

4. GMP for Quality & Quality for Life 1 Respect its claim Perform as committed Deliver benefits Protects hope Removing Fog to Enhance Clarity

5. Compliance is not Choice but Obligation 2 Removing Fog to Enhance Clarity

6. Compliance is not Choice but Obligation 2 Health is a constitutional right Law and rules Removing Fog to Enhance Clarity

7. Compliance is not Choice but Obligation 2 Health is a constitutional right Law and rules Penalty and criminal proceedings Removing Fog to Enhance Clarity

8. Compliance is not Choice but Obligation 2 Drug manufactured under non- GMP environment is an adulterated drug and subject to penalty & criminal proceedings Health is a constitutional right Law and rules Penalty and criminal proceedings Removing Fog to Enhance Clarity

9. Humans Contaminate Drugs 3 Removing Fog to Enhance Clarity

10. Humans Contaminate Drugs 3 Training & Professional Development Removing Fog to Enhance Clarity

11. Humans Contaminate Drugs 3 Skill, knowledge, ability, aptitude, experience Shed particles from skin, hair, clothes Become source of microbial load Ignorance, negligence, omission, commission Training & Professional Development Removing Fog to Enhance Clarity

12. Ignorance brings Disaster 4 Removing Fog to Enhance Clarity

13. Ignorance brings Disaster 4 Mix up Contaminated Fail to deliver Loss of potency Etc. etc. Removing Fog to Enhance Clarity

14. Confusion Promotes Mix up & Mix up is nothing but Disaster 5 Removing Fog to Enhance Clarity

15. Confusion Promotes Mix up & Mix up is nothing but Disaster 5 Physically safe and secure is the requirement Removing Fog to Enhance Clarity

16. Confusion Promotes Mix up & Mix up is nothing but Disaster 5 Physically safe and secure is the requirement Dedicated flow and movement control Removing Fog to Enhance Clarity

17. Confusion Promotes Mix up & Mix up is nothing but Disaster 5 Free flowing Heavy traffic Crossing lines Insecure and unsafe Unattended Physically safe and secure is the requirement Dedicated flow and movement control Removing Fog to Enhance Clarity

18. Feel smoke before it appears 6 Removing Fog to Enhance Clarity

19. Feel smoke before it appears 6 Improve certainty and protect quality Removing Fog to Enhance Clarity

20. Feel smoke before it appears 6 From reactive to preventive & from preventive to predictive Improve certainty and protect quality Removing Fog to Enhance Clarity

21. Regulatory Methodology to inspect manufacturing practices of drugs is called

22. Good Manufacturing Practices Regulatory Methodology to inspect manufacturing practices of drugs is called

23. Integrity & Quality of manufactured products for human use is protected by

24. Good Manufacturing Practices Integrity & Quality of manufactured products for human use is protected by

25. Production & Control of consistent products is ensured by

26. Good Manufacturing Practices Production & Control of consistent products is ensured by

27. • Documentation • Traceability • Trust • Predictability is provided by

28. Good Manufacturing Practices • Documentation • Traceability • Trust • Predictability is provided by

29. • Identity, quality & strength of drugs • Correct procedures are followed • Timely documented • Reviewed before release is assured by

30. Good Manufacturing Practices • Identity, quality & strength of drugs • Correct procedures are followed • Timely documented • Reviewed before release is assured by

31. Quality cannot be observed by every one and/or by naked eye Quality cannot be tested in a laboratory but has to be built in to the product We know We know

32. If a drug is manufactured in GMP environment & qualifies all tests, Is it sufficient for quality or something remains?

33. Surveillance Complaints Recalls Vigilance

34. Pure Consistent Zero Mix Up DRUG 1 2 3 Batch after Batch Within Batch Time after Time

35. Lets see from another angle

36. Doctor does not want to kill patient, pilot does not want crash …. But it happens sometime

37. Batch manufactured …….. Testing completed ….. Batch history reviewed ………… But Temperature recording of room was found out of limit when batch was manufactured Can the batch be released?

2 - GMP June 2022 - CQS.pdf

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