The Ministry of Food and Drug Safety (MFDS) has released new guidelines to improve manufacturing and quality control of generic drugs made through consignment contracts.

The new rules have made clear the consignor and consignee's roles and responsibilities and the contents required for making quality agreements.

It defines consignors as manufacturers of raw materials, additives, in-process material, and finished drugs. Consignees are those who do all or part of the manufacturing on behalf of the consignor.

Making medicines include several individual tasks or activities. The manufacturing company can complete all the works and businesses by themselves or select companies to do so, depending on the contract.

In the case of consignment manufacturing, the consignor's quality assurance department is responsible for final approval or disapproval of drugs made by the consignee. Moreover, the quality department's responsibilities and procedures must be documented and followed under regulations.

The quality agreement has to clearly define the roles, manufacturing activities, and responsibilities of consignors and consignees according to the good manufacturing practice (GMP) standards. Also, the agreement has to include personnel in charge of communication between the two parties.

So far, the contracts for consignment manufacturing have been managed without specifying details related to complying with the GMP standards. However, the ministry has decided to clearly distinguish and manage consignors and consignees' duties and responsibilities to have manufacturing and quality control carried out thoroughly.

"We are planning to improve the quality and supervising capabilities of generic drugs by promoting revisions to the regulations on manufacturing and quality control of medicines to require well-defined responsibilities of consignors and consignees," the ministry said.