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• Defines specs and methods for all products and methods of manufacture and CommandRoutinely evaluation and update files to replicate present practices and specifications. Utilize Variation Command mechanisms to avoid the inadvertent usage of outdated variations.Paperwork/data which have a diminished use and people whose storage in a distan
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Sensitive biologics can destabilize if frozen or heated incorrectly, leading to unsafe and unusable ultimate product. Also they are sensitive to numerous interactions within the lyophilization process that may induce the proteins to unfold, resulting in loss of therapeutic efficiency with the patient2. Multi-part mixtures which will not crystalliz