(F) this specification and professional and technical training system and records.
Article 50: Preparation management documents include:
(1) Preparation procedures and standard operating procedures
Preparation procedures include: the name of the preparation, dosage form, prescription, preparation process requirements, raw materials, intermediate products, finished products, quality standards
qualified and technical parameters and storage precautions, finished product containers, packaging materials, and other requirements.
Standard operating procedures: unit operations involved in the preparation process (e.g., heating, stirring, shaking, mixing, etc.) specific provisions and requirements to be achieved
.
(2) Preparation records
Preparation records (preparation form) should include: number, preparation name, date of preparation, preparation batch number, the name of the relevant equipment and operation records,
the amount of raw materials, the number of finished and semi-finished products, the control of the preparation process records and records of the handling of special circumstances and the operator of each process, the reviewer,
the signatures of the clearing house. .
Article 51 The quality management documents of the preparation mainly include:
(1) quality standards and inspection operation procedures of materials, semi-finished products and finished products;
(2) records of investigation of stability of the quality of the preparation;
(3) inspection records.
Article 52 Requirements for preparation preparation management documents and quality management documents:
(1) The formulation of documents shall be in accordance with the requirements of the Drug Administration Law and relevant laws, rules and regulations;
(2) A management system for documents shall be established. Documents used shall be the approved current text, and withdrawn and outdated documents shall not be present at the work site, except for keeping them in the file
for inspection.
(C) the responsibility for the formulation, review and approval of documents should be clear and signed by the responsible person;
(D) the relevant preparation records and quality inspection records should be completely filed and kept for at least 2 years for inspection.
Chapter VIII Preparation Management
Article 53 The preparation procedures and standard operating procedures shall not be modified arbitrarily. If there is a need for modification must be in accordance with the procedures for the formulation of the revision
Ordering, approval procedures.
Article 54 In the same preparation cycle to prepare a certain number of routinely prepared preparations for a batch, a batch of preparations in the prescribed limits
degree of the same nature and quality. Each batch of preparation shall be prepared preparation 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 shall be confirmed that there is no leftover from last time;