The purpose of revising Annex 1 is to reflect the changes that have occurred in the legislation and production of sterile medicinal products since the first edition in 2007. The latest revised version of EU GMP Annex 1 starts from the chapter on isolator systems, specifically proposing the integrity testing of gloves on isolator devices. The new regulations involve the definition of the time intervals for glove testing, thus standardizing the usage criteria for manufacturers. In fact, the first edition of Annex 1 drafted in 2007 stipulated that glove leakage tests must be carried out frequently, but did not provide any further specifications. The newly released revised version precisely fills this gap, stating that for isolators, glove tests must be conducted at specified time intervals, at least at the start and end of each production batch.

Anified laboratory biosafety standard is adopted. Pathogenic microorganisms are managed in a classified manner, and laboratories are managed in a graded manner.

Based on the infectivity of pathogenic microorganisms and the degree of harm to individuals and groups after infection, pathogenic microorganisms are classified into four categories. Among them, Category I and Category II are collectively referred to as highly pathogenic microorganisms, which can cause very serious/serious diseases in humans or animals. According to the biosafety protection level of laboratories, laboratories are divided into Level 1, Level 2, Level 3, and Level 4. Level 1 has the lowest protection level, and Level 4 has the highest protection level.

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Biodeconta Decontamination conducted regular hydrogen peroxide - based spatial cleaning, purification, and disinfection for the biological laboratory of a cell - therapy company in Beijing. This laboratory was established in accordance with GMP standards, and the client required the disinfection effect to reach the log6 level.

Laboratory animals are artificially bred animals with controlled microorganisms they carry, and have clear genetic backgrounds or known sources. They are used for scientific research, teaching, production, inspection, and other scientific experiments. They are classified into conventional (CV), specific pathogen free (SPF), and germ free (GF) grades.
The requirements for the environment of a laboratory animal facility are relatively strict. Besides environmental parameters such as temperature, humidity, and illuminance, there are also corresponding requirements for cleanliness and sedimentation bacteria. Taking an SPF laboratory animal facility as an example, the environment