1. An inventory record must be maintained for the cotton used as a filler in a bottle of tablets because it touches the product; therefore, it is a container closure.
2. A copy or specimen of the label used to identify trays of unlabeled vials must be kept as a permanent record.
3. The laboratory must review, approve and maintain the records for the preparation of a primary reference standard used to test batches for release.
True False
4. You do not need to validate the cleaning of laboratory glassware by performing swab testing.
5. For an automated cleaning process, there is no requirement to periodically revalidate the cleaning procedure in the absences of changes. Visual examination is acceptable.
6. There is no GMP requirement to employ stock rotation for the use of pre printed cartons.
7. Personnel who work in a class 10,000 area (e.g., unloading the autoclave) do not have to participate in a media fill validation if they do not enter a class 10,000 aseptic processing area (e.g., aseptic filling room).
8. It is not acceptable to apply the USP content uniformity test criteria (i.e., 85-115%, RSD <6.0%) to the validation of blend uniformity.
9. When the purity of an active ingredient is less than 100.0%, a calculation is required to determine the excess amount needed to formulate the drug product at 100% of its label claim, as required by 211.101.
10. When the microbial load of the potable water exceeds the FDA action limit of 500 CFU per mL, it is acceptable to install a filter to reduce that microbial load.
11. When the stability sample is prepared as a composite of multiple dosage units (e.g., a grind of 20 tablets), this same method of preparing the composite must be used at all stability testing intervals.
