This document discusses Good Manufacturing Practices (GMP) for pharmaceutical products as outlined by the World Health Organization (WHO). It provides definitions and explanations of key GMP concepts including quality assurance, quality management, and ensuring consistent production of pharmaceuticals according to appropriate quality standards. It also discusses WHO involvement in establishing GMP guidelines and differences between GMP and current Good Manufacturing Practice (cGMP). The document outlines basic GMP principles for quality management, sanitation, qualification and validation, complaints and recalls, and more. It emphasizes that quality failures can result in regulatory warnings, market withdrawals, supply disruptions, and loss of credibility with patients and regulators.

1. 5/18/2021
Dr. Ashwani Dhingra
9996230055
ashwani1683@gnkgei.ac.in

2. WHO GOOD
MANUFACTURING
PRACTICES FOR
PHARMACEUTICAL
PRODUCTS
General Principles

3. WHAT ARE GOOD
MANUFACTURING
PRACTICES?

4. Good manufacturing practice (GMP) is
that part of quality assurance which
ensures that products are consistently
produced and controlled to the quality
standards appropriate to their intended
use and as required by the marketing
authorization.

5. ■part of quality assurance
■ensures that products are
consistently produced and
controlled
■quality standards appropriate to
their intended use
■as required by the marketing
authorization

6. Why is the WHO involved in GMP?
GMP is aimed primarily at diminishing the risks inherent in
any pharmaceutical production, which may broadly be
categorized in two groups:
 cross contamination/mix-ups
 false labelling
Above all, manufacturers must not place patients at risk due to
inadequate safety, quality or efficacy; for this reason, risk
assessment has come to play an important role in WHO quality
assurance guidelines.

7. WHO GMP versus WHO cGMP
At the most basic level, GMP stands for Good
Manufacturing Practice and cGMP stands for
current Good Manufacturing Practice.
Regulators seek to impress upon drug
manufacturers the need for continuous
improvement in their approach to product quality.

8. Basic Principles of GMP
Quality
Management
Sanitation
and Hygiene
Qualification
and
Validation
Complaints
and Recalls
Contract
Production
and Analysis

9. Basic Principles of GMP…. Contd.
Self Inspection
and Quality
Audits
Personnel
Premises Equipment
Materials

10. Basic Principles of GMP…. Contd.
Documentation
Good Practices
in Production
and Quality
Control
Sterile
Production
Active
Pharmaceutical
Ingredients
GMP Inspections

11. Quality Management Objectives
■ To understand key issues in quality assurance/ good manufacturing
practices/quality control.
■ To understand specific requirements on quality management and quality
assurance including:
 Organization
 Procedures, processes and resources.
■ How to use Quality Management to resolve your current problems?

12. Quality Relationships
Quality Management
Quality Assurance
GMP
Production and Quality Control

13. What is Quality Management?
 The aspect of management function that determines and implements the
“quality policy”
 The overall intention and direction regarding quality, as formally expressed
and authorized by top management

14. QUALITY
POLICY

15. GSK Quality Policy
Quality is at the heart of all activities that support the discovery, supply and
marketing of products to our patients and customers.
Quality is critical to building trust with society and therefore, to our future business
success.

16. INDIVIDUAL YET
COLLECTIVE
RESPONSIBILITY

17. Basic Elements of Quality
Organization
Structure
Quality
System
Processes
Procedures
Resources
The totality of these actions is termed “Quality Assurance”

18. What do Quality Failures lead to?
• Regulatory Authority Warning Letters
• Complaints, Market Withdrawals and Recalls
• Loss of credibility with Regulator
• Supply disruptions and Loss of Credibility with Patients and Customers
• Huge amount of re-work – Investment of Money and Time

19. AND WHAT LEADS
TO A QUALITY
FAILURE?

20. An Eye Off the Ball is all it
takes!!
Big Mess!!

21. Let us see some live examples
FAILURE TO HIRE RIGHT EMPLOYEES
- Right mix of experience and qualification
- Relevant to current product line
- Technical knowledge
- Attention to detail
- Understand the cGMP principles
- Make others realize value of GMP

22. https://www.fda.gov/ICECI/E
nforcementActions/WarningL
etters/ucm601181.htm

23. Do the Production and Quality Assurance Personnel have
adequate knowledge?

24. FAILURE TO MAINTAIN ADEQUATE FUNDS
- GMP requires resources – defined budget, fund allocation
- Materials, processes are expensive - Cannot be commanded at gunpoint
- Technical staff need to emphasise the importance to senior management
- Technical Staff at senior levels
- May be a challenge in family owned businesses

25. https://www.fda.gov/ICECI/En
forvementActions/WarningLet
ers/2017/Ucm546483.htm

26. Your response indicates that you evaluated the impact of these
laboratory deviations and believe they pose a low risk. The response
lacks a commitment to perform a comprehensive evaluation of your
microbiology laboratory controls and practices.
NEED TO DEMONSTRATE COMMITMENT TO cGMP COMPLIANCE

27. FAILURE TO MANAGE TIME
- GMP needs to be built in ahead of production
- If TIME FOR GMP = ZERO, there will be ZERO GMP.
- Prioritize trainings…continuous education
- Spend time in facility design evaluation and selection of the right equipments
- Identify internal auditors and conduct mock audits.

28. Who is responsible for Quality?

29. THANK YOU!
QUESTIONS?