Labeling, Packaging, Serialization


Labeling

Labeling

Lesson Code: PGI-780. The importance of accurate labeling in a pharmaceutical plant. What must be contained on a label, along with label distribution and reconciliation.

Labeling in API Plants

Lesson Code: BGI-580. The importance of accurate labeling in an API plant. What must be contained on a label, along with label distribution and reconciliation.

Packaging

Preparing for Packaging

Lesson Code: PGI-770. Pharmaceutical packaging is introduced and pre-packaging checks required before a packaging operation can begin, are explained.

Primary Packaging

Lesson Code: PGI-771. Principles of primary packaging and the processes involved.

Secondary and Tertiary Packaging

Lesson Code: PGI-772. Principles of secondary & tertiary packaging and the processes involved.

Serialization

Serialization and Product Tracking

Lesson Code: SER-800 (PREMIUM LESSON). An overview of serialization and product tracking including the commercial and regulatory drivers, the technologies involved and the process of implementing a serialization and product tracking solution.

Four Level Serialization Structure

Lesson Code: SER-801 (PREMIUM LESSON). An overview of serialization architecture in the pharmaceutical industry. It describes the four levels of a serialization system and the IT functions associated with each.

Serial Number Generation

Lesson Code: SER-802 (PREMIUM LESSON). How serial numbers are generated, transactions associated with serial numbers, and how serial numbers are classified and sorted.

Serial Number Transmission

Lesson Code: SER-803 (PREMIUM LESSON). How serial numbers are transmitted from point of origin, through the different levels to where they are printed on packaging. It also describes the function of individual devices on the packaging lines.

Serialization - Aggregation and Error Management

Lesson Code: SER-804 (PREMIUM LESSON). How aggregation in serialization is performed, along with aggregation-related concepts such as parent-child relationships and error management.

Serialization - Exception Events, Disaggregation, and Reaggregation

Lesson Code: SER-805 (PREMIUM LESSON). Events that require disaggregation along with procedures for performing disaggregation and reaggregation.

Serialization and the Supply Chain

Lesson Code: SER-806 (PREMIUM LESSON). What happens to serialized products when they leave the production facility, how change of ownership is accomplished and how compliance with the DSCSA and DQSA is achieved.