The Difference Between ISO and GMP Standards
Good Manufacturing Practices (GMP, also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
Source: World Health Organisation
ISO certifications are global standards that are internationally recognised and agreed upon by a collection of experts, distilling the wisdom of people with expertise in their subject matter and an understanding of the needs of the organisations they represent.
Source: ISO
What are ISO Standards?
The governing cleanroom standard is ISO 14644, which is a suite of standards covering a breadth of cleanroom related areas such as cleanroom design, construction, airflow, maintenance and particulate testing. ISO 14644-1 covers the classification of air cleanliness and dictates the number of particles accepted per cubic metre of air in order to be granted a certain ISO classification. These can be found on our cleanroom classifications page.
What are GMP Standards?
Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes.
GMP cleanrooms need more stringent levels of control than ISO cleanrooms, so the GMP Guidelines take reference from the ISO standards, adding more layers of compliance for materials, airflow patterns, occupancy states, validation states, and more.
What do ISO and GMP standards mean for cleanrooms?
A GMP-compliant cleanroom will also have an ISO classification, but an ISO 14644-1:2015 graded cleanroom may not qualify for a GMP cleanroom grade, as GMP Annex 1 requires extra conditions (above those stipulated in ISO 14644-1:2015) to meet the minimum requirement for medicines manufacture.
The GMP guidelines reference the ISO standard, both with an at-rest particulate contamination level of acceptance and as an operational level of acceptance. As client’s working towards GMP compliance go through go through a formal DQ IQ OQ PQ protocol; when it comes to PQ, they will look at their process and assess that their SOPs are in-line with the amount of particulate that’s getting generated.
This process gives the opportunity to formalise procedures and reduce the risk of going out of specification when in operation.
The latest EU GMP Annex 1 requirements focus on eliminating the risk of product contamination during the manufacturing process and when the completed product leaves the cleanroom environment. This is all about driving high standards in sterile pharmaceutical manufacturing and protecting patients from any potential ill effects of contamination.
Many industries are governed by their own regulations and through the implementation of cleanroom standards, Angstrom Technology deliver additional levels of compliance.
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