Presentation T 23

MCT Beginning T 23

1 Good Manufacturing Practices T 23

MCT GMP T 23

2 Process approach T 23

MCT Process approach T 23

3 Personnel T 23

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 Premises

Let's continue with this MCT (multiple-choice test) to see what you have learned about premises
(One or more correct answers are possible)

1. The premises ensure the risk reduction of mixing:

Products
Containers
Ingredients
Production areas

2. A separate area is provided for activities such as:

Training
Quarantine
Laboratory
Packaging
Shipment

3. Preferred means of cleaning:

Brush
Vacuum cleaner
Wet cloth
Compressed air

4. Clause 4 of ISO 22716 contains the following sub-clauses

Lighting
Ventilation
Consumables
Calibration

5. Lighting of production areas:

Is adequate
Is used, among other things, to heat the product
Is sufficient
Protects the products in case of breakage

Summary of clause 4 T 23