Table 1 Requirements for a batch production and QC record

Production

The name, batch number, total radioactivity, volume and expiry time and date of the SSRP

The name and weight or measure of each active ingredient and component as well as a statement of the total weight or measure of any dosage unit

Records of any checks and system suitability tests performed

The batch numbers of all components used (expiry dates may be included)

A complete list of components and equipment designated by sufficiently specific names or codes

Names (initials or signatures) of persons performing or checking each significant step in the operation and any investigations conducted

A statement of practical yield, including the maximum and minimum percentages of practical yield beyond which investigation is required

Deviations from written procedures

Quality Control (QC)

A description of the sample received for testing including its source, batch or lot number, date and time the sample was taken

A description of each method used in the testing of the sample, a record of all calculations performed in connection with each test and a statement of the weight or measure of the sample used for each test, if relevant

Records of any checks and system suitability tests performed

A record of relevant data obtained during each test, including graphs, charts, and spectra from laboratory instrumentation, properly identified to show the specific component, in-process material, or SSRP for each lot tested

A statement of the test results and how the results compare with established acceptance criteria

The initials or signature of the person performing the test and the date and time of the test

Deviations from written procedures

A clear statement of approval or rejection including the time and date of release and the signature of the person designated to release the batch