GMP and ISO standards
GMP Standard
Principles and standards of good manufacturing practice (GMP) are recognized and widely applied worldwide in the field of pharmaceutical manufacturing. In many countries, GMP principles and standards are included in legal documents to ensure compliance by businesses involved.
Grade 1 packaging is an indispensable component in pharmaceutical production, they come into direct contact with pharmaceutical products and directly affect the quality of pharmaceutical products, so quality control of level 1 packaging is imperative in the operation. pharmaceutical production.
Pharmaceutical manufacturers act as the final checker for the quality of grade I packaging before they are put into production, but to truly ensure and improve the quality of primary packaging they need to be. must come from tier 1 packaging suppliers/manufacturers.
The general standard principles of GMP are fully applicable in the production of grade I packaging to ensure consistent and continuous quality of the product produced. Then, thanks to GMP raw materials, GMP grade 1 packaging combined with GMP manufacturing process, will create the final pharmaceutical with the best quality to care for human health.
In Vietnam, GMP for pharmaceutical packaging is a mandatory requirement, a content of the legal document issued by the state in Circular 14/2012/TT-BYT. That can be the importance as well as the attention of the national management agency in controlling the quality of grade 1 packaging.
Understanding the GMP quality system and the benefits of applying GMP standard principles in creating quality grade 1 packaging products, PGA Grade 1 Packaging Joint Stock Company has built a factory to manufacture bags. Grade 1 packaging meets GMP standards for pharmaceutical packaging to provide customers with the most prestigious and quality products.
ISO standards
ISO 15378 standard belongs to the international quality standard system applied in packaging production for the pharmaceutical industry. ISO 15378 is recognized and applied worldwide.
ISO 15378 is built on the basis of ISO 9001 with reference to the requirements of good manufacturing practice (GMP) so ISO 15378 is essentially similar to the GMP standard for pharmaceutical packaging.
Currently in Vietnam, companies producing grade 1 packaging for the pharmaceutical industry apply ISO 15378 more than GMP for pharmaceutical packaging.
However, ISO is an international standards organization, with a broad mandate, many organizations can evaluate and provide certificates while the compliance, quality and reputation of the certification bodies vary. are not the same. For the same reason, Vietnamese management agencies only accept ISO 15378 certification which is assessed by reputable certification organizations such as Bureau, Veritas, TUV, SQS, SGS, IQnet, BSI, DQS, GTU, International Certification Management GmBH.
Grade 1 packaging factory of Grade I PGA Joint Stock Company was built to meet GMP standards for pharmaceutical packaging. In the near future, the factory will also conduct appraisal to be granted ISO 15378 certificate to meet the requirements of all customers when coming to PGA.v
