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7.1 Good manufacturing practices for biologicals
The Committee supported collaboration between the two Expert Committees (Specifications for Pharmaceutical Preparations, and Biological Standardization) in the area of GMP for biologicals.
The Committee was informed that, in order to define a strategy for the revision, a series of workshops assembling regulators and manufacturers of biological products had been conducted to gather information on the users' needs for the interpretation and implementation of GMP. Based on a gap analysis, it was recommended that a biologicals-specific core section should be provided, in which the requirements common to all biologicals …