Presentation T 23

MCT Beginning T 23

1 Good Manufacturing ...T 23

MCT GMP T 23

2 Process approach T 23

MCT Process approach T 23

3 Personnel T 23

Case: Importance of work

Case: Clean room T 23

Summary of clause 3 T 23

MCT Personnel T 23

4 Premises T 23

Summary of clause 4 T 23

MCT Premises T 23

5 Equipment

Summary of clause 5

MCT Equipment

6 Raw materials

Case: Selecting suppliers

Summary of clause 6

MCT Raw materials

7 Production

Case: Task priority

Case: Process stability

Case: New line

Case: Change

Summary of clause 7

MCT Production

8 Finished products

Summary of clause 8

MCT Finished products

9 Laboratory

Summary of clause 9

MCT Maboratory

10 Nonconforming products

Case: Communication

Case: Nonconformities

Case: Kaizen and problem

Summary of clause 10

11 Wastes

Case: Customer and need

Summary of clause 11

MCT Nonconforming products

12 Subcontracting

Summary of clause 12

MCT Subcontracting

13 Deviations

Summary of clause 13

14 Complaints and recalls

Summary of clause 14

15 Change controls

Summary of clause 15

16 Internal audit

Case: Audit readiness

Case: Auditor question

Case: Audit program

Case: Audit report

Summary of clause 16

MCT Internal audit

17 Documentation

Summary of clause 17

MCT Documentation

18 Placing on the market

MCT End

MCT Beginning T 23

We will begin with a MCT (multiple-choice test) to evaluate the level of your knowledge

(One or more correct answers are possible, so make sure you tick all the right answers)

1. Examples of production process:

Sterilize
Stir the mixture
Fill the containers
Audit
Control documentation

2. The process approach, among other things:

Ensures document control
Relies on process management
Allows roles and responsibilities to be clarified
Allows reducing costs, delays and waste

3. The premises ensure the risk reduction of mixing:

Products
Containers
Ingredients
Production areas

4. The first edition of ISO 22716 appeared in:

2007
2008
2009

5. Laboratory release results meet acceptance criteria related with:

Quality and reliability of materials for use
Quality and reliability of products for shipping
Customer

Presentation T 23

1 Good Manufacturing ...T 23