Department Project No. Document No. Doc Rev....Revision exercise or written task . Important : Important points to remember for the assessment : Quick Link or Tip : A shortcut, tip,

Training Handbook Department TRG Project No. 190101 Document No. HBK001 Doc Rev. 01

© 2019 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited. Page 1 of 13 pages

TRG_TMP650_05_r03

Good Distribution Practice Training Handbook

Presented By Maria Mylonas

Department TRG Project No. 190101 Document No. HBK001 Doc Rev. 01


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. The following icons are used in this handbook.

Activity Revision exercise or written task

Important Important points to remember for the assessment

Quick Link or Tip A shortcut, tip, or favourite link

Discussion Group discussion activity

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 2019. For further information go to www.pharmout.net



TRG_TMP650_05_r03

Table of Contents

How to use this handbook ............................................................................... 2 Table of Contents ............................................................................................. 3 1. What is GDP/GWP? ................................................................................. 4 2. Quality Definition .................................................................................... 4 3. Change Control ....................................................................................... 5 4. CAPA - Cold Chain Temperature Excursion ............................................. 7 5. Control of contamination ........................................................................ 9 6. Product Recall ....................................................................................... 10 7. Preliminary Hazard Analysis (PHA) – Cold Chain Distribution .............. 11 8. Transfer of Learning Plan ...................................................................... 13



TRG_TMP650_05_r03

1. What is GDP/GWP?

1. What is GDP/GWP? 2. Why is GDP/GWP required? 3. Why must you comply with GDP/GWP?

Write your answers below.

2. Quality Definition

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



TRG_TMP650_05_r03

3. Change Control

A new transport provider,” PharmaMove Transport” is required for cold chain transportationnationally. You have determined this is a major change.Complete the chance control form below to initiate this change.

PharmaMove Document ID: <FP703-1>

Revision No.: <01>

Training Handbook Effective Date: 18-Apr-19

Name Position Date

Prepared by: Steve Williamson QA Associate 16-Apr-19Reviewed by: James Dickson QA Manager 17-Apr-19Authorised by: Maria Mylonas QA Director 17-Apr-19

Change ID#: 20190401 Change request information: Change requested by: Date:

Description of change: Document Equipment Product Other

[list what changes are required, systems/product affected etc]

Reason for change: [Justify why the change is necessary]

Effect of change: Product affected: Yes No NA Revalidation required: Yes No NA

Equipment/facility change: Yes No NA Process flowchart affected: Yes No NA Procedures/Training update required: Yes No NA Customer approval required: Yes No NA

Registration impacted: Yes No NA Document update(s) required Yes No NA

Risk Assessment required: Yes No NA If ‘No’ provide justification: [eg. Minor change]



TRG_TMP650_05_r03

Change ID#: 20190401

Other impacts of the change:

Change Action Plan:

Department Manager: Title: Date: Approval of change Implementation date: Date: Approved Rejected Reason for Approval/Rejection:



TRG_TMP650_05_r03

4. CAPA - Cold Chain Temperature Excursion

An unbroken cold chain consists of an uninterrupted series of storage and distribution activities which maintains a given temperature range, based on sponsor’s recommended conditions for product stability integrity stated on the TGA approved product packaging. Scenario A cold chain product was delivered to ABC Pharmacy by PharmaMove Transport on Friday 26th April 2019. When the pharmacist was unpacking the delivery, they noticed that the ice packs had melted and the temperature tag within the box indicated that the product was out of the required specification of 4-8°C. The pharmacist rang the customer service department to raise the issue, and to arrange for a replacement delivery. The customer service department logged the non-conformance as per the internal non-conformance management process and the quality coordinator was informed. A CAPA investigation was initiated and the following issues were discovered: • The product was packed on April 24th but not delivered until the 26th due to Anzac day

public holiday on the 25th April. • The number of ice packs in the package was 2. The validated packaging configuration, for

this time of year requires 4 ice packs in each package.

What would be your Correction(s), Corrective Action(s) and Preventive Action(s)? Complete the table(s) below.



TRG_TMP650_05_r03

Correction(s)

Corrective Action(s)

Preventive Action(s)



TRG_TMP650_05_r03

5. Control of contamination

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

1. Review your work area and list the potential sources of contamination. 2. What controls do you have in place? 3. Are the controls working or have they failed previously?

Potential source of contamination

Control Strategy / Mitigation Working/

Not working



TRG_TMP650_05_r03

6. Product Recall

What were the issues with this recall?

What potential effect did the recall have on J&J?

What potential effect can a recall have on your company?



TRG_TMP650_05_r03

7. Preliminary Hazard Analysis (PHA) – Cold Chain Distribution

For this activity we will identify the hazards associated with Cold Chain Distribution. Consider aspects such as:

• Temperature • Light • Vibrations • Packaging • Storage

Use the table on the following page to record your answers:

a. In the first column, list the hazard (potential source of harm) b. In the second column, list the harm (the potential damage caused by the

hazard) c. In the third column list the control strategy



TRG_TMP650_05_r03

Hazard Harm Control Strategy / Mitigation

Storage temperature goes out of specification



TRG_TMP650_05_r03

8. Transfer of Learning Plan

Action Comments

What did you learn today?

What specifically will you implement from today?

What do you need to follow up on and learn more about?

What do actions do you need to take to find out more about the topics you wrote above?

DOCUMENT END

Documents

Department Project No. Document No. Doc Rev....Revision exercise or written task . Important : Important points to remember for the assessment : Quick Link or Tip : A shortcut, tip,