ABSTRACT
After a product is filled into a primary container, if the container is a vial, it is stoppered (partially inserted for lyophilized products) and crimped with an aluminum seal. If the container is a syringe, it is stoppered with a rubber plunger. If the container is an ampoule, it is heat sealed. Products filled into glass or plastic bottles are rubber stoppered and sealed and products filled into plastic bags are heat sealed, usually employing form-fill-finish technology. However, for all these products, before final labeling and placement in secondary packaging for distribution, inspection for product defects must be conducted. This is part of the quality control and assurance program to ensure that only product dosage forms meeting all current good manufacturing practice (cGMP) attributes are released and available to the marketplace consumer.
