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

• 4.1 Principle
• 4.2 Areas
• 4.3 Space
• 4.4 Flow
• 4.5 Floors
• 4.6 Toilet facilities
• 4.7 Lighting
• 4.8 Ventilation
• 4.9 Pipework
• 4.10 Cleaning
• 4.11 Maintenance
• 4.12 Consumables
• 4.13 Pest control

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

 

The premises efficiently provide:

• the protection of the product
• maintenance, cleaning and sanitization
• reduction the risk of mix-up of:
  • products
  • raw materials
  • ingredients
  • packaging items
  • containers 
  • consumables

Decisions on the design of the premises take into account the type of cosmetic product manufactured, the existing environment, and the cleaning and sanitization methods used.

 

Receiving, production, inspection, storage, shipping, ancillary, toilet and sanitary areas are identified, defined and separated.

 

Necessary and preferably separate space is provided for all activities related to the cosmetic product such as:

•  receipt
• sampling
• quarantine
• storage in reception
• measurement and weighing in production
• distribution
• transformation
• storage of bulk products
• laboratory
• packaging
• inspection
• storage of finished products
• maintenance
• shipment

The flow of materials, productsany outcome of a process or activity (see also ISO 9000, 3.4.2) and personnel is clearly established. Establishing and adhering to one way flow greatly reduces the possibility of contamination.

The floors, walls, ceilings and windows of the production rooms facilitate cleaning and sanitization to keep them clean and in good repair.

When ventilation is adequate the windows do not open. If the windows do open a screen is put in place.

New constructions allow efficient cleaning and maintenance. It is preferable to use smooth surfaces that are resistant to the corrosive action of cleaning and sanitizing agents.

 

Toilets and washrooms are kept regularly clean and ventilated. Toilets and sanitary facilities are separated from production areas. Shower rooms may be provided.

 

The lighting is adequate and sufficient for all areas of the company. The lighting is such that in the event of breakage, the containment of debris is ensured and the productany outcome of a process or activity (see also ISO 9000, 3.4.2) is protected in all circumstances.

 

Ventilation is adequate to guarantee production activities and the productany outcome of a process or activity (see also ISO 9000, 3.4.2) is protected in all circumstances. Particular attention is paid to the treatment of dust-generating productsany outcome of a process or activity (see also ISO 9000, 3.4.2), such as compact powders or talcum powder.

Pipework, drains and ducts do not permit the contamination of materials, productsany outcome of a process or activity (see also ISO 9000, 3.4.2), surfaces and equipment by leakage or condensation.

Drainage lines are kept clean and are sloped sufficiently to prevent back flow.

When designing consider:

• avoid exposed overhead roof beams, pipes and ducts
• keep exposed pipes away from walls to allow for cleaning
• in all circumstances protect the product

Premises for receiving, production, inspection, storage and dispatch activities are regularly maintained in a clean condition to protect cosmetic products. Cleaning and sanitizing agents are specified and effective. Cleaning and sanitizing programs for each area are established and adhered to.   

The processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) "Clean and sanitize premises and equipment" describes the activities related to the cleaning and sanitization of premises and equipment.   

In order to avoid contamination, cleaning methods such as vacuuming and wet wiping are preferred over compressed air or brushes.

The maintenance in a good state of repair of the premises for the activities of reception, production, inspection, storage and shipment is established and followed.  

Consumables used for cleaning, sanitization and maintenance of the premises for receiving, production, inspection, storage and shipment do not affect the quality of the productsany outcome of a process or activity (see also ISO 9000, 3.4.2) manufactured.

Premises for receiving, production, inspection, storage and shipment activities are designed, constructed and maintained to limit the access of insects and pests. A cleaning and checking program is established and regularly monitored. Measures are taken to ensure that pests are not allowed to enter the premises.