Article 53 The preparation procedures and standard operating procedures shall not be arbitrarily modified. If there is a need for modification, the procedures for revision and approval must be carried out in accordance with the procedures at the time of formulation.
Article 54 In the same preparation cycle prepared a certain number of routinely prepared preparations for a batch, a batch of preparations within the limits of the same nature and quality. Each batch of preparation shall be prepared with a batch number.
Article 55 Each batch of preparations shall be examined according to the material balance of inputs and outputs, and if there is any significant difference, the reasons must be identified, and after arriving at a reasonable explanation and confirming that there is no potential for quality accidents, the preparations may be handled in accordance with normal procedures.
Article 56 In order to prevent the preparation from being contaminated and confused, the following measures shall be taken in the preparation operation:
(1) The field shall be cleared after each preparation and the record of clearing shall be filled in. Before each preparation, it should be confirmed that there is no leftover from last time;
(ii) Preparation operations of different preparations (including different specifications of the same preparation) shall not be carried out in the same operation room at the same time.
If it is really unavoidable, the preparations must be made in different operating stations, and measures shall be taken to prevent contamination and confusion;
(iii) Cross-contamination caused by weighing, sieving, crushing, etc., which may result in powder dispersion, shall be prevented in the process of preparation;
(iv) Containers used in the process of preparation shall be labeled with signs indicating the name of the material, batch number, status, and quantity etc. (e) The containers used in the preparation process shall have signs indicating the name, batch number, status and quantity of materials.
Article 57: Selection of process water according to the preparation regulations. Process water shall meet the quality standards and regular inspection. According to the results of the verification, the test cycle.
Article 58 Each batch of preparations should be a complete record reflecting all aspects of preparation. The operator shall fill in the record in time, with clear handwriting, true content, complete data, and signed by the operator, reviewer and clearer. The record should be kept neat and clean, and should not be torn or altered arbitrarily. When changes are required, the person making the changes should sign the changes and make the changed part recognizable.
Article 59 The preparation process of new preparations and the main equipment shall be verified according to the verification program. When the main factors affecting the quality of the preparation, such as the preparation process or quality control methods, the main raw materials and auxiliary materials, the main preparation equipment, etc. changes, as well as the preparation of a certain period of time, re-validation should be carried out. All verification records should be archived.