How to Monitor Quality in the Pharmaceutical Industry

Each lot of pharmaceuticals must be tested to meed FDA approval standards.

The Food and Drug Administration has strict guidelines and requirements that pharmaceutical manufacturers must adhere to with regard to quality. Whether you are bottling honey for grocery stores or manufacturing antihistamine tablets, there are strict guidelines regarding purity, potency and sterility.

Things You'll Need

• FDA recommended lab testing chemicals

Instructions

1. Contact the FDA and request quality monitoring training for your business.

2. Attend the quality monitoring classes with the FDA agent and mention all specific products and concerns.

3. Obtain the agent's recommended list of testing chemicals for your specific product. This will vary for every product on the market. Examples of tests recommended by the FDA include capillary electrophoresis, spectroscopy and gas chromatography.

4. Pull a sample from each lot as it comes off of the production line and run each quality test.

5. Track the results by lot number. To avoid the bad publicity associated with recalls, always complete testing before that particular lot leaves the warehouse.

6. File your results annually or more often upon request with the FDA.

References

• FDA: Analytical Procedures And Methods Validation
• Consumer Healthcare Products Association: FAQs About Manufacturing Quality
• FDA: Q10 Pharmaceutical Quality System