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The manufacture of sterile products covers a wide range of sterile product
types (such as active substances, excipients, primary packaging materials and
finished dosage forms), packed sizes (single unit and multiple units), processes
(from highly automated systems to manual processes) and technologies (for
example, biotechnology, small molecule manufacturing and closed systems).
This guideline provides general guidance that should be used in the design and
control of premises, equipment, utilities, systems and procedures used for the
manufacture of all sterile products. The principles of quality risk management
should be applied to ensure that microbial, particulate and endotoxin/pyrogen
contamination is prevented in the final product.
The principles of quality risk management should be applied in all
sections of this document and will not be referred to in specific paragraphs.
Where specific limits, frequencies or ranges are reflected, these should be
considered as a minimum requirement. They are referred to based on historical
regulatory experience where issues that have been identified could impact the
safety of products and patients.
WHO Expert Committee on Specifications for Pharmaceutical Preparations Fifty-sixth report
The intent of this guideline is to provide guidance for the manufacture
of sterile products. Some of the principles and guidance, such as contamination
control strategy (CCS), design of premises, cleanroom classification, qualification,
validation, monitoring and personnel gowning, may be used to support the
manufacture of other products that are not intended to be sterile, such as certain
liquids, creams, ointments and low bioburden biological intermediates, where
the control and reduction of microbial, particulate and endotoxin/pyrogen
contamination are considered important. Where a manufacturer elects to apply
guidance in this document to non-sterile products, the manufacturer should
clearly document which principles have been applied and acknowledge that
compliance with those principles should be demonstrated