Validation Introduction - GMP Consultants, pharmaceutical ......Validation EU Annex 15 FDA:...

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Validation Introduction Presented by John Montalto 27 March, 2013

Transcript of Validation Introduction - GMP Consultants, pharmaceutical ......Validation EU Annex 15 FDA:...

Page 1: Validation Introduction - GMP Consultants, pharmaceutical ......Validation EU Annex 15 FDA: Pharmaceutical cGMPs For The 21st Century ICH Q9 FDA: Quality System Approach to Pharmaceutical

Validation Introduction

Presented by John Montalto

27 March, 2013

Page 2: Validation Introduction - GMP Consultants, pharmaceutical ......Validation EU Annex 15 FDA: Pharmaceutical cGMPs For The 21st Century ICH Q9 FDA: Quality System Approach to Pharmaceutical

Slide 2 © PharmOut 2013

John Montalto

Bachelor of Science

Management Diploma

>15 years of Industry Experience

Consultant to United Nations various Government Regulatory Agencies

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Lei Hao

This activity is a “getting to know you” exercise:

• Introduce yourself

• Validation experience/exposure

5 min/?

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Course structure

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Course objectives

PIC/S Annex 15 Qualification and validation

Process validation

Cleaning validation considerations

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Activity

• With the person next to you, discuss the following:

• Define the term ‘Validation’

• What does ‘Quality’ mean to you?

• What do you expect from a validation program?

• Contribute to the group discussion

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The history of validation

The concept of validation was initially proposed in the mid-1970’s

Several significant issues with high volume aseptic products were realised

The early concept of validation was to verify the robustness of the manufacturing processes

Two US FDA regulators Ted Byers and Bud Loftus are recognised as having significant influence in validation

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The history of validation

Where the early concept of validation was to verify the robustness of the manufacturing processes, later efforts spread to:

Production environments

Media fill processes

Purified water production

Equipment sanitation

Facility services

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The history of validation

Validation activities were (and still are) based on engineering practices.

› For example, how large, complex items of equipment are manufactured, tested, delivered and accepted to fulfil contractual obligations.

› More recently in 2005 the concept of validation spread to cold chain distribution processes.

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The history of validation

Validation continues to evolve, but the core attributes remain consistent:

Improve patient safety

Verify the adequacy of processes

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Influences on validation

|1987 | 2000 |2002 | 2004 | 2006 | 2008 2010 | 2011 |

FDA Guide to Process Validation

EU Annex

15

FDA: Pharmaceutical cGMPs For The

21st Century

ICH Q9

FDA: Quality System

Approach to Pharmaceutical

cGMP

PICS VMP

ISPE C&Q Baseline 5

Guide

ISPE 21st Century

Qualification White Paper

ICH Q8

ASTM E2500-

07

FDA Process

Val. Guidance

Draft EMA

Process Val

ASTM E2500-

07

ICH Q10

ICH Q11

EU / PIC/S Annex

15

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Top 10 Most Frequently Cited GMP Deficiencies (PIC/S Member Authorities) (July 2010 – June 2011)

1. Documentation on manufacturing

2. Design & maintenance of premises

3. Documentation – quality systems elements/procedures

4. Personnel issues – training

5. Design & maintenance of equipment

6. Cleaning validation

7. Process validation

8. Product Quality Review

9. Supplier & contractor audit

10. Calibration of measuring & testing equipment

Source: Presentation by H. Smallenbroek (IGZ, Netherlands) & B. Meow Hoe (HSA, Singapore) on “Review of similarities &

differences of top 10 deficiencies cited by PIC/S participating authorities”, PIC/S Seminar, Cape Town, Nov’11.

Will be repeated (& further discussed) at PDA-PICS Workshop, Geneva 9-10 May 2012.

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Top 10 Most Severe GMP Deficiencies (PIC/S Member Authorities) (July 2010 – June 2011)

1. Design & maintenance of premises

2. Contamination, potential for (chemical, physical, microbial)

3. Design & maintenance of equipment

4. Sterility assurance

5. Batch release procedures

6. Process validation

7. Cleaning validation

8. Investigation of anomalies

9. Documentation – quality systems elements/procedures

10. Regulatory issues – noncompliance with marketing authorisation

Source: Presentation by H. Smallenbroek (IGZ, Netherlands) & B. Meow Hoe (HSA, Singapore) on “Review of similarities &

differences of top 10 deficiencies cited by PIC/S participating authorities”, PIC/S Seminar, Cape Town, Nov’11.

Will be repeated (& further discussed) at PDA-PICS Workshop, Geneva 9-10 May 2012.

Page 15: Validation Introduction - GMP Consultants, pharmaceutical ......Validation EU Annex 15 FDA: Pharmaceutical cGMPs For The 21st Century ICH Q9 FDA: Quality System Approach to Pharmaceutical

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Top Ten GMP Deficiencies found by MHRA (UK) (from MHRA web site Aug 2011)

1. Investigation of Anomalies

2. Quality management

3. Quality management (Change Control)

4. Validation Master Plan & Documentation

5. Corrective Action/Preventative Action (CAPA)

6. Complaints and Product Recall

7. Documentation

8. Equipment Validation

9. Quality Management –Product Quality Review

10. Investigation of Anomalies - OOS

Slide 15

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Why validate?

Validation is:

• A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation.

• Testing a sample of a final product is not considered sufficient evidence that every product within a batch meets the required specification

"Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.“

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Laying the foundations

Understanding the principles of validation is the foundation for

ensuring the process produces a quality product consistently.

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Thank you for your time. Questions?

John Montalto

[email protected]

Training Manager / Lead Consultant

www.pharmout.net


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