Good Manufacturing Practice

Objectives

• Acknowledge and understand the consequences of inadequate manufacturing practice;
• Analyse such consequences of negligent compounding, esp. in the context of complex compounding (e.g., sterile compounding); and
• Understand what a pharmacist is allowed to compound in Australia.

Principles

Rules of engagement are simple

• GMP: compulsory guidance about what, where, who, how etc. of the medicines manufacturing process

• All meds manufactured must follow the GMP

• Compounding is also medicines manufacturing, just smaller scale (typically 1 patient)

• GMP in compounding is used as a guide but not compulsory

Exercise 1: Analysing recalls

1. Check TGA Recalls shorturl.at/x1IIy (ex one eye eye why)
2. Query for 01-JAN-2017 – 28-NOV-2017

What are the three classes of recalls?

• I: potentially life-threatening or could cause a serious risk to health;
• II: could cause illness, injury or result in mistreatment (but not under Class I);
• III: may not post significant hazard to health, but the action may be initiated for other reasons e.g., QC issues.

Exercise 1: Analysing recalls (35 mins)

Objectives

1. Go over the recalls analysis questions
2. Prepare a brief presentation on your selected recall
3. As a group, we'll present to the class

How many recalls were there?

Exercise 2: When compounding goes wrong

1. Have a read thru New England Meningitis Outbreak shorturl.at/LjEKM

2. What were the problems?

3. What GMP violations? Link to GMP shorturl.at/R4NXj

Exercise 2: When compounding goes wrong

What were the problems?

• 800 cases of fungal meningitis
• nearly 100 died
• 83 out of 321 vials ... contained greenish black foreign matter
• “clean room” had mould and bacteria, A/C was also off
• Dark particulate and white, filamentous substances were covering the air duct

Exercise 2: When compounding goes wrong

GMP Violations

• Ch 1: Quality system is faulty

• Ch 2: Personnel not trained

• Ch 3: Premise and equipment

• Ch 4: False records