MANUFACTURING

Question 1

The packaging, repacking, or changing the container, wrapper or label of any drug package in preparation for its distribution from the manufacturer to the final user.

Answer 1

Manufacturing

Question 2

Small scale preparation of drug products, prescription order specific to a particular patient

Answer 2

Extemporaneous compounding

Question 3

Finished dosage form with or without active ingredients

Answer 3

Drug product

Question 4

Pharmaceutical form of the preparation based on official pharmacopeia

Answer 4

Dosage form

Question 5

Produced from a single order within same cycle of manufacturing

Answer 5

Batch

Question 6

Specified portion of batch

Answer 6

Lot

Question 7

Means a desgination printed on the label of a drug or device that identifies the batch, and oermits thr production history of the batch including all stages of manufacture and control, to be traced and reviewed

Answer 7

Batch number

Question 8

Refers to any distinctive combinations of letters and/or numbers assigned to a particular lot, herein drfined as a portion of a batch

Answer 8

Lot number

Question 9

Any establishments engaged in operations involbed in the production of a drug, including propagation, processing, compounding, finishing, filling, packing, repacking, altering, ornamenting and labeling with the end in view of storage, distribution or sale of the product: provided that for the purpose of this regulation the compounding and filling of prescriptions in drugstores and hospital pharmacies shall not be considered as production operations

Answer 9

Drug manufacturer

Question 10

Any establishment which is a registered owner of the drug product, procures the materials and packaging components, and provides the production monographs, quality control standards and procedures, BUT sub-contracts, the manufacture of such product to a licensed manufacturer. In addition, a trader may also engage in distribution, and/or marketing of its product.

Answer 10

Drug trader

Question 11

Means any establishments that imports raw materials, active ingredients and/or finished products for its own use or for wholesale distribution to other drug establishments or outlets

Answer 11

importer

Question 12

Means any drug establishments that exports raw materials, active ingredients and/or finished products to another country

Answer 12

exporter

Question 13

Means any drug estsblishment that exports raw materials, active ingredients and/or finished products from local establishments for local distribution on wholesale bases

Answer 13

Wholesaler

Question 14

Department in drug establishment responsible for the sale and distribution of drugs

Answer 14

Marketing department

Question 15

Department in a drug establishment responsible for procuring raw materials and packaging materials

Answer 15

Purchasing department