I. Catalogue of application materials for application materials for pharmaceutical packaging materials
(1) Provincial (Food) Drug Administration's assessment report on the production status of the drug packaging materials of the reporting unit.
(2) Three batches of declared product quality inspection reports issued by the pharmaceutical packaging materials inspection agency set up or determined by the State Food and Drug Administration.
(3) Clean room (area) cleanliness inspection report issued by the State Food and Drug Administration's pharmaceutical packaging materials or issued by the drug inspection agency.
(4) Applying for a business license.
(5) A summary of the production, sales and application of the declared products.
(6) Formula of declared products.
(7) Description of the production process and main production and inspection equipment of the declared product.
(8) The quality standards of the declared products.
(9) Self-inspection report of the three batches of products declared by the manufacturer.
(10) Research data of the stability test (drug compatibility test) carried out at the same time as the drug packaged with the declared product.
(11) Floor plan of the declared product production plant area and clean room (area).
(12) Relevant certificate of conformity obtained by applying for environmental protection, waste gas and waste water discharge, safety and fire protection of the declared product manufacturing enterprise in compliance with relevant national laws and regulations.
Application requirements for the production of pharmaceutical packaging materials
(1) The above materials (1), (2), and (3) shall be provided in originals.
(2) A copy of the above-mentioned item (4) can be provided.
(3) If the materials in item (7) above are new drug packaging materials or enterprise standards, drafting instructions should be provided at the same time.
(4) The above-mentioned item (8) shall be submitted with the original test report within one year from the date of application.