Question

Identify the consequences of the following cGMP violations:

1. NOT taking daily temperature readings for a blood refrigerator

2. Extending test incubation times beyond what the SOP states

3. Overloading a refrigerator beyond its capacity

4. Cutting an employee's training short

5. Running proficiency samples over and over until the sample is used up

6. Using expired reagents 7. Reporting test results when controls are out of range

8. Not performing preventative maintenance on an instrument as required by the manufacturer

Answer 1

     1. NOT taking daily temperature readings for a blood refrigerator

If the daily temperature of the blood refrigerator is not taken as high or low temperature can damage the blood cells and platelets. It is important to store the blood at temperature range of 4 to 6 degree Celsius and although the blood refrigerator has temperature setting, it is important to monitor the temperature. The maintenance of an appropriate temperature is necessary to ensure that RBC can retain its ability to carry the oxygen.

      2. Extending test incubation times beyond what the SOP states

If the incubation time is extended beyond what is stated by the SOP state, it tends to increase the chance of contamination. It tends to cause the haemolysis and hence the rate of sedimentation increases leading to increase in the contamination.

3. Overloading a refrigerator beyond its capacity

On overloading the refrigerator beyond capacity, it will lead to spoiling of sample due to the decreased cooling caused by reduced airflow across the refrigerator.

4. Cutting an employee's training short

On cutting an employee’s training short, the employee will not have proper knowledge leading to errors and mistakes in handling. The handling mistakes can lead to a lot of loss.

5. Running proficiency samples over and over until the sample is used up

Proficiency test is basically external quality test which helps in identifying the quality and scope of improvement. If the test is done again and again, it will reduce the sample and hence there will be shortage.

6. Using expired reagents range

It is not recommended to use expired products as the pharmaceutical ingredient, or the main ingredients lose its potential and might lead to side effect.

7. Reporting test results when controls are out of

When the controls are out of range, the test results produced are not reliable and hence it can lead to adverse effect. The test results can be wrong as there is nothing against which the comparison can be drawn.

8. Not performing preventative maintenance on an instrument as required by the manufacturer

If the preventive maintenance is not done on the instrument, it might lead to spoilage or damage of the instrument and hence it might delay experiments and give errors. If it is a storage instrument, it will lead to spoilage and wasting of samples.