Professional Documents
Culture Documents
The Company shall have a Quality Management System established, documented, implemented, maintained and where appropriate, improved.
1. 4 Complaint Handling
The Company shall have a system for the management of product complaints and their investigation.
1. 5 Management Review
The Company shall conduct management reviews to demonstrate the effectiveness of the system.
1. 6 Design Control
The Company shall ensure the product design is effectively controlled to meet with customer, safety, & legality requirements.
1. 8 Training
The Company shall ensure that all employees are adequately trained, instructed and supervised commensurate with their activity.
1. 9 Document Control
The Company shall ensure that all documents, records and data critical to the management of product safety, legality and quality are in place and
effectively controlled.
2 GOOD MANUFACTURING PRACTICE (GMP)
The Company shall apply Good Manufacturing Practice so as to prevent contamination and enable the production of safe and legal products.
2. 3 Lighting
The fabrication of the facilities including the lighting shall be suitable for the intended purpose with due regard to the risk of product
contamination and damage.
2. 4 Equipment and Maintenance
Equipment shall be suitably designed for the intended purpose and shall be used so as to minimize the risk of contamination and damage of
product.
2. 5 Cleaning
Appropriate standards of cleaning shall be maintained at all times.
2. 6 Health and Personal Hygiene
Appropriate standards of hygiene and housekeeping shall be maintained at all times.
2. 7 Pest Control
The Company shall be responsible for minimizing the risk of pest infestation on the site.
2. 8 Glass Control Program
Appropriate facilities and procedures shall be in place to control the risk of glass or other physical contamination or damage of product.
4. 1. 3 Pilot Run
4. 2 Reference Samples
The Company shall ensure that reference samples, or component samples are held and are available for appropriate personnel or referral.