1.1 Manufacturing Process
In the manufacturing process there are more chances for contamination from starting materials to packaging materials. To reduce contamination the following can be considered
The facility should be limited for manufacturing of a single product formulation
Products which are manufactured in campaign should be qualified with proper cleaning procedures and checks should be done to reduce quantity of product change overs
A closed manufacturing system is preferred as the product here is not exposed to room environment immediately
The line clearance should performed in accordance with procedures by following cleaning process between each batch
Divide the facility to zones
All the equipment’s used within the location should be labelled regarding their cleaning status
1.2 Clothing
Proper training should be given on good practices to be followed and bearing responsibility for consumer health.
Role and responsibilities of the employee should be explained during the employment and on the job training should also be given for the same
Gowning and degowning procedures should be detailed and monitored regularly
Personal should wear suitable clothing given by procedures in addition to the following:
Personnel protective equipment
Body coverings
Clothing which can withstand wear and laundry
Suitable footwear like shoe covers or steel capped shoes should be given by the company
1.3 Air
Clean filtered air should be given from raw material stage to finished product and packing stage
Contaminants due to air can be controlled by filtration and ventilation
Cross contamination during processing, manufacturing process, clothing, filtration, ventilation