Contamination Control In and Out of the Cleanroom: Contamination Control and CGMP

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Contamination Control In and Out of the Cleanroom: Contamination Control and CGMP

Controlling the fabrication environment is not an end in itself. Manufacturers who process and assemble their product in controlled environments know that the clean-room or mini-environment must be appropriately designed and must also be maintained clean and contamination free. H...

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Changes to ISO 9001 – Implications for Organisations

Organisations may have to align their management systems with the structure of the revised standard. As an example the organization’s quality manual may need to be amended. A risk management processes may need to be developed to determine the level and extent of control for “...

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