Where relevant standard data or Infusion mould Suppliers are concerned, the relevant documents or standard names and numbers should be clearly marked to increase the scientificity and reliability of the simulated filling test assessment. After the above table is evaluated, the test plan and supporting test records are designed according to the proposed content.
Formation of simulated filling test plan
Compared with the conventional process verification, the special content of the simulation filling test is that in the process of critical process control points and key process parameters evaluation, attention should be paid to the design and investigation of the *difference conditions and manual intervention in the process operation. The full picture of the filling test can be simulated by evaluating and summarizing all production steps throughout the aseptic filling process. Combined with the HACCP method assessment, the medium simulated filling test protocol and production record should include:
(1) Evaluation of key process control points. Based on the decomposition of the operation steps in the whole process of filling, the key control points of the process operation are determined through the evaluation of the impact on the microbial load or sterility, and any increase in microbial load, aseptic performance or GMP risk may be As a key control point.
(2) According to the operational requirements and management requirements of the key control points, formulate specific control measures, process parameters, and control methods. If there is a document, directly quote the contents of the relevant documents.
(3) According to the operation situation of key control points, list the manual interventions that may affect the microbial limit, aseptic performance and GMP risk, and formulate the investigation plan of manual intervention, and make test records.
(4) According to the requirements of vacuum infusion moulding process, formulate the *difference conditions of the production operations of the key control points, formulate the inspection plan, and make the test records. According to the design process, according to the requirements of the verification scheme, a detailed test plan and test records are formed, and the simulation filling test plan and batch production record are respectively formed.