Do you have a program in place to ensure that your facility is inspecting these materials before use?
A company recently received this 483 observation:
….. There is a lack of written procedures describing in sufficient detail the receipt, identification, storage, sampling, examination and testing of labeling and packaging materials.
Specifically, your company’s written procedure for receiving and shipping of products does not describe in sufficient detail the receipt, identification, storage, sampling, examination, testing of labeling and packaging materials.
a. There are no records kept for each different labeling and packaging material shipment.
b. There is no data recorded for the receipt, results of examination or testing, and a statement of whether the shipment was accepted or rejected.
c. Labeling and packaging materials are not sampled, examined or tested upon receipt and before use in packaging and labeling of a drug product.
d. Labels and other labeling materials are not stored separately with suitable identification for each different drug product, strength, dosage form or quantity of contents.
e. Access to the storage area for labels and labeling materials is not limited to authorized personnel.
f. Your facility does not have established physical or spatial separation for packaging and labeling operations to prevent mix-ups.
g. Obsolete or outdated labels, labeling and packaging materials are not destroyed.
For more observations pertaining to packaging and labeling see Issue 1033 available today. It also has observations pertaining to manufacturing controls, laboratory controls and medical device manufacturing controls.