Tag: Wrexham Qatar

SOP ON SWAB /RINSE SAMPLING PURPOSE: To lay down a procedure for sampling a swab or rinse sample from different equipment or areas.    SCOPE: This SOP applies to sampling rinse or swabs from different equipment/parts/areas at various stages of product processing. REFERENCE: In-House CROSS-REFERENCE DOCUMENTS Quality Risk Management SOP on Investigation ATTACHMENTS: S.No. Attachment No. Attachment…

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PRODUCT PROCESS QUALIFICATION (PPQ) PURPOSE: The purpose of this procedure is to provide a high degree of assurance of meeting all the predefined attributes and the process is capable of consistently delivering quality products. SCOPE: This SOP is applicable for Process Qualification activities of drug products manufactured. REFERENCE(S) ISPE, Volume 5, Commission & Qualification. Guidance for Industry:…

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