Recognizing that mastering international standards is a prerequisite for operating a modern pharmaceutical factory, Reiwapharm Pharmaceutical Factory recently co-organized an intensive training course on the “Good Manufacturing Practices (GMP) Principles and Standards” for its factory personnel. This is regarded as a strategic step to strengthen internal capabilities, preparing for the official launch and operation of the factory.
What is GMP? Why Must a Pharmaceutical Manufacturing Plant Achieve This Certification?
First promulgated in 1962, the Good Manufacturing Practices (GMP) guidelines represent a set of principles and standards for the production of drugs and drug raw materials. They ensure that products are consistently produced and controlled according to quality standards appropriate to their intended use and as required by marketing authorizations.
In Vietnam, the Ministry of Health mandates that all pharmaceutical manufacturing and business establishments obtain GMP certification. Therefore, this standard serves not only as a mandatory legal framework for products to be legally distributed in the market, but also as proof that products are manufactured under safe conditions and strictly controlled processes, thereby building trust with consumers and partners.
The “Good Manufacturing Practices” Training Course: Momentum for Reiwapharm Pharmaceutical Factory
With over 10 years of experience in the pharmaceutical industry, TV TPI thoroughly understands the importance of GMP certification. Therefore, as part of preparations for the launch of Reiwapharm Pharmaceutical Factory, TV TPI conducted a training course on “Good Manufacturing Practices” for personnel at Reiwapharm to enhance knowledge and stay updated on current regulatory changes.
The training session was honored to welcome Pharmacist Ta Thi Phuc Chan – Former Head of the Quality Control Department and Former Head of the Drug Registration Department at the Drug Administration of Vietnam (Ministry of Health), and Founder of CPharma Pharmaceutical Co., Ltd.
Drawing from her extensive industry experience and work with numerous pharmaceutical manufacturers, Pharmacist Ta Thi Phuc Chan delivered valuable insights on GMP certification to the trainees at Reiwapharm:
- WHO GMP Principles: Exploring the regulatory documentation framework governing GMP in Vietnam, the 5 core elements of GMP, and the procedures for GMP assessment and validation.
- WHO GMP Guidelines for Sterile Medicinal Products: Learning fundamental GMP principles in the manufacturing of sterile pharmaceutical products, as well as quality assurance aspects in sterile product manufacturing and control.
- Updates on Current Regulations and Requirements for Sterile Injectable Manufacturing Plants.
Proactively equipping personnel with standardized knowledge during the pre-operational phase not only strengthens technical competence and process understanding among Reiwapharm Pharmaceutical Factory’s staff, but also creates a solid launchpad. This prepares the factory to complete evaluation procedures smoothly and confidently establish its position as a high-quality, compliant pharmaceutical manufacturing plant in the industry.
