Regulations related to weighing
In gmp, there are as many as 55 search results for weighing, and the key parts of them are excerpted below:
Article 52: The weighing of raw materials and excipients of preparations should usually be carried out in a specially designed weighing room.
Article 53: Dust-generating operation rooms (such as sampling, weighing, mixing, packaging, etc. of dry materials or products) should maintain a relatively negative pressure or take special measures to prevent dust diffusion, avoid cross-contamination and facilitate cleaning.
Article 123: Ingredients should be made by designated personnel in accordance with operating procedures to ensure that qualified materials are accurately weighed or measured and properly marked.
Article 124: Each material prepared and its weight or volume shall be independently reviewed by others, and a record of the review shall be made.
Xianteng weighing system is developed in accordance with the GMP5 good automated production practice guidelines and FDA 21 CFR Part 11 specifications, so that the production and manufacturing process of the enterprise complies with GMP and cGMP regulations, and ensures the integrity of product quality and production data. Avoid weighing errors and improve weighing efficiency.
Pharmaceutical companiesThe weighing process without real-time MES has the following problems
1.The data generated in the weighing process cannot be transmitted to SAP in real time, and cannot be shared with orders and other processes;
2.There are certain risks in manual extraction of weighing data and manual calculation of formulas;
3.Manual label writing is time-consuming and labor-intensive.
After the implementation of MES weighing management, the production formula review, accurate weighing, weighing label issuance, and material traceability are solved. Real-time collection, real-time collection and transmission of weighing equipment data, so that managers can quickly know the changes in production, carry out targeted regulation and control of production, and achieve effective control of production.
Support PDA or tablet operation.
Feeding can be confirmed by scanning.
Automatically review the feeding material and the feeding port (to avoid the wrong material and the wrong feeding port).
The feeding sequence can be managed.
When the feeding requirements are not met (wrong delivery, wrong sequence, etc., interception) will be reminded.
Standardize weighing operations according to SOP specifications to reduce weighing errors.
Automatically check the weight of the material according to the recipe to avoid errors.