Chuyên mục: Quality

Good Documentation Practices (GDP) in EU-GMP Inspections

Good Documentation Practices – GDP are essential pillars within the pharmaceutical industry, serving as the

ICH: GLOBAL STANDARDS FOR PHARMACEUTICAL QUALITY

In the context of globalization, the demand for high-quality pharmaceuticals is increasing, especially as new

Critical aspects of temperature validation for sterilization equipment

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

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

Production Batch Record – Part 2: Electronic Batch Record

In the previous post, SEN Pharma pointed out some limitations of paper batch records, which

Introduction of process validation

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

Production Batch Record – Part 1: The limitation of Paper Batch Records

A batch record is a mandatory GMP document in which every factor and action impacting

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,