Regulations for Registration of Medicinal Products Article 11

The Manufacturing and Control Standard mentioned in this Chapter refers to the Manufacturing and Control Standard in compliance with Part 2 of Good Manufacturing Practice Regulations (Good Manufacturing Practices for Pharmaceuticals), including data of the actual amount of material used in batch records.The manufacturing records mentioned in this Chapter refer to the manufacturing records of the same lot as the samples submitted for tests. In the case where the data of the same lot is not available or the products are exempt from testing, the applicant can submit the manufacturing records of any batch produced within two years from the date of application or a representative batch.The representative batch is a batch of drug product that is manufactured using the same formulation, manufacturing process, and in-process controls, etc. as the application for drug registration or post-approval changes. The applicant should provide proof of the unaffected product quality for the change of the manufacturing process and in-process controls, and should be approved by the central health competent authority.