You will not always be informed about an FDA inspection in advance, so you need to be fully prepared if you want to avoid those pesky warning letters and citations! (Form 483).
The FDA (Food & Drug Administration) has gotten more stringent with their acceptance criteria, especially when it comes to food and drug or medical device companies.
Here are a few tips to help you prepare:
Cleaning, Care and Maintenance of Microscopes
Microscopes are sophisticated optical instruments that require periodic maintenance and cleaning to guarantee production of high-contrast images equal to the quality of the optical, electronic, and mechanical components. When neglected by exposure to dust, lint, pollen, and dirt, failure to remove immersion oil in a timely manner, or when expensive objectives are abused, optical performance can experience a serious decline that increases over time.
A Microscope that remains unused for a lengthy period can accumulate dust and debris from the air, which can lead to deterioration of image quality even though the instrument may be practically new. Proper use and regular maintenance of the microscopes mechanical components are equally important to prevent impairment of operation and eventual damage to the entire mechanical integrity of the instrument.
To protect your microscope, it requires a regular cleaning and maintenance schedule to ensure your images remain crisp and artifact free.
Calibration can be defined as a process where a comparison is made between (2) two entities; One whose value must be measured and the other entity, known as the standard, which is used as the reference in the comparison. This process includes the adjustment of any instrument to bring it into alignment with the standard.
Electronic equipment calibration involves the scientific comparison of two instruments. One instrument should have a known, or proven, correctness so that the other may achieve the same quality. The biggest electronic calibration objective is to achieve accuracy and precision. The correctness in turn guarantees efficiency of measurements in healthcare centers, laboratories, and other FDA industries. The proper diagnosis and treatment of patients is assured while prescription of drugs in in order.
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