I. INTRODUCTION

The final step in packaging and labeling an active pharmaceutical ingredient (API) can also be considered as the first step in the manufacture of a dosage form. Consequently this step is important and should be performed in a manner consistent with the dosage form GMP requirements.

II. STANDARD REQUIREMENTS

A. Areas used for packaging of active pharmaceutical ingredients (API) where the API will not undergo further purification steps, need to meet the standards of the current GMP for cleanliness. The facilities and controls used should be nominally equal to those for the formulation of non-sterile drug products.

B. The generation and handling of labels for API must conform to customer and local requirements.

C. Appropriate procedures shall be in place to make sure the area used for the packaging and labeling operation has been cleared of other APIs, labeling, and packaging components from previous operations immediately prior to use.

D. The area, scales, equipment, utensils, etc., shall be cleaned if a different API was previously handled prior to processing the next scheduled batch such that cross contamination does not occur.

E. The clearance of the area will be described in unit procedures and documented in appropriate log(s) or records.

F. Systems shall be in place to assure the correct API is packaged, the correct labels applied, and appropriate packaging materials used.

G. Only containers and closures approved by QA/QC may be used. Approved in the above context means the packaging components are evaluated in the API stability testing program, conform to regulatory requirements and each batch of a container or closure which is in direct contact with the API is released by QA/QC.

H. Each container packaged must have a label or a suitable means of insuring the identity (API name and batch number) of the material in the package. A system based on use of identification tags on each container may be used for intra- plant shipment instead of a commercial label.

I. An electronic system or a 100 percent visual examination must be performed to make sure the containers are correctly labeled.