The main sections of the standard are as follows
Category 1 : Packaging that comes into direct contact with high risk products (ref glossary for definition of high risk products).
Category 2 : Packaging for high risk products that does not come into direct contact with such products
Category 3 : Packaging for products with low risk with regard to standards of hygiene but which must clearly meet defined functional requirements.
Requirements
| 1 |
Senior Management Commitment and Continual Improvement |
| 2 |
Hazard and Risk Management System |
| |
| 2.1 |
Hazard and Risk Management Team |
| 2.2 |
Hazard and Risk Analysis |
| 2.3 |
Hazard and Risk Management Pre-requisites |
|
| 3 |
Technical Management System |
| |
| 3.1 |
Technical Management Policy |
| 3.2 |
Quality Manual |
| 3.3 |
Customer Focus and Contract Review |
| 3.4 |
Internal Audits |
| 3.5 |
Supplier Monitoring |
| 3.6 |
Subcontracting of Production |
| 3.7 |
Documentation Control |
| 3.8 |
Specifications |
| 3.9 |
Record Keeping |
| 3.10 |
Traceability |
| 3.11 |
Complaint Handling |
| 3.12 |
Management of Incidents and Product Recalls |
|
| 4 |
Site Standards |
| |
| 4.1 |
Perimeter and Grounds |
| 4.2 |
Security |
| 4.3 |
Layout and Product Flow |
| 4.4 |
Building Fabric |
| 4.5 |
Maintenance of Plant and Equipment |
| 4.6 |
Staff Facilities |
| 4.7 |
Housekeeping and Cleaning |
| 4.8 |
Waste and Waste Disposal |
| 4.9 |
Pest Control |
| 4.10 |
Transport, Storage and Distribution |
| 4.11 |
Traceability |
|
| 5 |
Product and Process Control |
| |
| 5.1 |
Product Design and Development |
| 5.2 |
Process Control |
| 5.3 |
Product Inspection and Analysis |
| 5.4 |
In-line Testing Equipment |
| 5.5 |
Calibration |
| 5.6 |
Control of Non-conforming Product |
| 5.7 |
Foreign Body Control |
| 5.8 |
Chemical and Biological Control |
|
| 6 |
Personnel |
| |
| 6.1 |
Training |
| 6.2 |
Access and Movement of Personnel |
| 6.3 |
Personal Hygiene |
| 6.4 |
Medical Screening |
| 6.5 |
Protective Clothing |
|
