Definitions
This is the dating that tells a customer when the product is expired
Expiration Dating
This system supports manufacturing by testing, releasing, approving and rejecting materials and finished product
Laboratory System
Clean Room
Classified
In both of these series is to outline and general operations of the systems
PL100 and PR100 series
Careful not to go over that open container
PL300
A distinctive combination of letters, numbers, or symbols, from which the complete history of the manufacturing, processing, packaging, holding, and distribution of a batch or lot of drug product or other material can be determined.
Lot Number
These two systems are responsible for Compounding, sterile fill, and packaging and labeling.
Production System and Packaging and Labeling system
Compounding A and B1
Non-Classified
In this series you would find the operation of the Westcapper
PL500
12 in a box
PL500
A labeled product that is not compliant with cGMP regulations.
Adulterated-miss branded
In this system your responsibilities may include pulling and returning materials, FIFO, and duck/goose watching
Material System
Container Bulk A
Non- Classified
In this SOP series compounding and weighout processes are described
PL500 Series
Send me a set
PL600
What is Acceptance Criteria?
the product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan, that are necessary for making a decision to accept or reject a lot or batch
Better get a wrench and a sledge hammer the lab sterilizer needs to be fixed
Facilities and Equipment System
Vestibule
Non- Classified
In this series you will find DR performing Changeover procedure
PR400 series
Put the small nozzles on
PR400
This refers to one or more of the elements exposed to aseptic conditions and ultimately making up the sterile finished drug product.
Sterile Product
Better make sure you cross your t's and dot your i's or this department will hunt you down
Quality System
Packaging Labeling A
Both
Label Prep
PL400
Prep the Becodisc Filter
PL500