GMP Training Course · These lessons allow you to learn and practice the skills used throughout the course

Department TRG Project No. 200102_PHA Document No. PHA001 Doc Rev. 01

© 2020 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited. Page 1 of 11 pages

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GMP Training Course Blood, Tissue and Cellular Therapy

Training Handbook

Presented By

Maria Mylonas



TRG_TMP650_05_r03

How to use this handbook

The handbook is organized to focus on particular skills and revisions. These lessons allow you to learn and practice the skills used throughout the course. This intellectual property remains the property of PharmOut Pty Ltd. It is intended for training purposes and its format and contents are copy written by ©PharmOut 2020. For further information go to www.pharmout.net



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Table of Contents

How to use this handbook ............................................................................... 2 Table of Contents ............................................................................................. 3 1. What is GMP? .......................................................................................... 4 2. Quality Definition .................................................................................... 4 3. Quality Management System (QMS) ....................................................... 4 4. CAPA ....................................................................................................... 5 5. Departmental Risk Identification ............................................................ 6 6. Control of Contamination ........................................................................ 8 7. Cheat Sheet vs SOPs ............................................................................... 9 8. Good Documentation Practice .............................................................. 10 9. FDA Warning Letter Review .................................................................. 11



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1. What is GMP?

Write down your definition.

2. Quality Definition

• What does quality mean? • What do you expect from a quality product?

3. Quality Management System (QMS)

• What is a QMS? • Why do you need a QMS??



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4. CAPA

There are many problems that you will encounter during your manufacturing processes. In your groups, create a problem scenario. Scenario: What would be your Correction(s), Corrective Action(s) and Preventive Action(s)?

Correction(s)

Determine your Root Cause(s)

Root Cause(s)

Corrective Action(s)

Preventive Action(s)



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5. Departmental Risk Identification

There are various risks associated within our departments. These may be risks to the product, risks to the patient, risks to personnel etc. Within your groups, analyse the risks in your department and fill in the table on the next page.

Risk Level Risk Level = Severity x Probability x Detectability e.g. H = high M = medium L = low

Training Handbook Department TRG Project No. 200102_PHA Document No. HBK001 Doc Rev. 01


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Risk Analysis (Identify potential risks)

Risk Rating (L/M/H)

What controls are in place/should be in place?

Department TRG Project No. 200102_PHA Document No. HBK001 Doc Rev. 01


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6. Control of Contamination

We have different levels of control based on the requirements of our different products. Prevention of contamination is a critical component of quality compliance.

1. Think about your work area and list the potential sources of contamination/cross-contamination.

2. What controls should be in place to avoid each potential source that you listed? 3. Are the controls working? Or not working?

Potential source of contamination/cross-contamination

Control Strategy / Mitigation Controls working? Not working?



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7. Cheat Sheet vs SOPs

You are required to follow actual SOPs and not personal notes that you have written down during your training in a process.

Question Answer

Why can’t you use your own notes?

What are some of the current challenges you have with your SOPs?

Are there any current procedures that you use that you have extra side notes on or that you know lack information and need an update? If yes, list them and discuss the issues.

What improvements would you suggest are needed to your current documentation and records?



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8. Good Documentation Practice

For this activity we will identify the documentation issues associated with the batch record below and highlight potential risks to product quality.

Tip Circle all examples of bad documentation practices and provide reasons in this sample batch record.



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9. FDA Warning Letter Review

Review the warning letter case study provided. Summarise the main issues

DOCUMENT END

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GMP Training Course · These lessons allow you to learn and practice the skills used throughout the course