Chuyên mục: Quality

Critical aspects of temperature validation for sterilization equipment

Sterilization Process Sterilization is an important process used in the healthcare industry, pharmaceutical companies, and

Pharmaceutical companies in Vietnam pursue EU-GMP

EU GMP is a standard of good manufacturing practice for medicines issued by the European

Data Integrity – The achilles heel in pharmaceutical factories

In 2022, many pharmaceutical factories were entangled in data integrity (DI) issues during inspections by

Cleaning validation in pharmaceutical manufacturing

Medicine is of significance for human well-being, thus, the pharmaceutical production process must adhere strictly

Recurrence of quality defects – A serious issue

With the mission of promoting the development of the pharmaceutical industry, SEN Pharma always encourages

Introduction of process validation

What is the process validation? Process validation is the collection of data and documents that

Does the entire batch have to be destroyed if it does not meet pre-defined specifications?

Even if the process is validated, the equipment is qualified, the in-process parameters are controlled,

The need for Nitrosamine risk assessment?

The below video will summarize risk assessment methods for nitrosamines in drug products. Since 2018,

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