Sterile Drug Process Inspections

ARTICLES

Quality System - Sterile

As noted in Compliance Program 7356.002, the inspection of the quality system is two-phased. The first phase is to evaluate whether the Quality Unit has fulfilled their responsibility regarding the review and approval of procedures and assured their suitability for use. The second phase is to assess the data collected by the firm to identify potential quality problems. Read More

Facilities and Equipment System - Sterile

Compliance Program 7356.002 lists the general areas to cover when inspecting the Facilities and Equipment System. The areas are applicable to sterile drug products and should be covered if this system is selected. Read More

Materials System - Sterile

In sterile operations, the quality attributes of each of the materials (ingredients, WFI, containers, closures) have a bearing on the critical attributes of the finished product. Read More

Production System - Sterile

Compliance Program 7356.002 lists areas to cover when inspecting the Production System. Read More

Packaging and Labeling - Sterile

Compliance Program 7356.002 lists the areas to cover when inspecting the Packaging and Labeling Control System. All of the areas that are applicable to sterile drug products and should be covered if this system is selected for coverage. Read More

Laboratory Control System - Sterile

Compliance Program 7356.002 lists general areas to cover when inspecting laboratories. Inspections of sterile drug manufacturers should also cover microbiology laboratories. Read More

Sampling - Sterile

Samples of sterile drug products should be collected to document suspected contamination, adulteration or misbranding encountered during an inspection. Read More

Inspection Questions To Consider - Sterile

Here is an extensive list of questions provided as an aid in conducting inspections and obtaining information needed to assess a firm’s operations. Read More