Preventing Contamination in GMP eBook

Training outcome of the module:

Contamination is the presence of any foreign substance in our products. It may be:

– Physical: hair, foreign objects, dirt, dust, pollens.

– Chemical: cleaning agents, lubricants, other products.

– Microbiological: bacteria, molds, spores, yeasts.

Cross-contamination of product is caused by either:

– Contamination of a batch with a previous batch of the same product.

– Contamination with a different product through carryover or proximity of production lines.

– Contamination by a foreign starting material usually of the dispensary or in the store.

The prevention of the cross-contamination requires:

– The proper sealing, separation, and storage of raw materials.

– Care in management of the dispensary so as to exclude the opening of different lots of containers in close proximity.

– The thorough and rigorous cleaning of all equipment, utensils, transfer lines, extraction systems, and vessels after use.

– Re-inspection of equipment before use and line clearances at all stages of manufacture.

– Ensuring all air conditioning systems are serviced and properly maintained.

After finishing this module, you will be able to:

– List the common types of physical and chemical contaminants.

– Describe the consequences of producing contaminated products.

– Identify the potential sources of contamination at your worksite.

– List some ways that you can prevent contamination.

– Potential sources of physical and chemical contamination.

– How your facility has been designed to control contamination?

– Some practical ways to prevent contamination.