A. The product must not be in accord with the specifications of the foreign purchaser.

B. The product must not be sold or offered for sale in domestic commerce.

C. The product must not be in conflict with the laws of the country to which it is intended for export.

D. The product must not be labeled on the outside of the shipping package that it is intended for export.

A. Introduction of the API starting material

B. Production of Intermediate(s)

C. Isolation and purification

D. Physical processing and packaging

A. Inventory control

B. Safety assurance

C. Quality verification

D. Efficacy confirmation

A. The process information and the comparative analytical result of APIs from both companies

B. Information deemed appropriate by the regulatory authority

C. The process information and analytical result of Company X API

D. The process information and analytical result of Company Y API

A. To provide scientific evaluation of applications for international marketing authorization for safe, effective, and high-quality medicines for the ICH regions

B. To lobby for improved industry standards for the development of new safe, effective, and high-quality medicines for the ICH regions

C. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions

D. To protect and promote public health through the evaluation and supervision of safe, effective, and high-quality medicines for the ICH regions