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[DOC File]SITE FDA INSPECTION PREPARATION CHECKLIST
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SITE FDA INSPECTION PREPARATION CHECKLIST. Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks. Check each item as it is completed and record pertinent comments.
fda gmp inspection checklist

[DOCX File]APPLICATION CHECKLIST (ICH CTD)
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: GMP certificate/ proof of GMP compliance and the latest inspection report issued by the chosen reference agency should be submitted. If applicable, either the Application for GMP Evidence Evaluation or Application Form for Requesting An Overseas GMP Audit should be submitted for finished product manufacturing sites which are new to Singapore.
gmp audit checklist pdf

[DOCX File]APPLICATION CHECKLIST (ICH CTD)
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: a GMP certificate/proof of GMP compliance and the latest inspection report issued by the chosen reference agency should be submitted. If applicable, either the Application for GMP Evidence Evaluation or the Application Form for Requesting An Overseas GMP Audit should be submitted for finished product manufacturing sites which are new to ...
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[DOC File]Daily Pre-Shift Operation Checklist
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Daily Pre-Shift Operation Checklist - Upstairs 2. Order & Sealing Area: Check for cleanliness and proper operation. If unit is not used, mark with X. Note reason if not clean or not operating properly. Specify corrective action taken. Date: _____ Person Checking: _____ Sealing / Storage Area Pass Fail Fail Reason Corrective Action Taken Checked ...
fda gmp audit checklist pdf

[DOCX File]GOOD MANUFACTURING PRACTICE (EMP) CHECK LIST
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Good Manufacturing Practice – GMP . Audit . Checklist. Sr. # (Contents) Page # ... sterilizing, washing, depyrogenation, visual inspection, standard operating procedure etc. HYGIENE. Are all the personal under gone health examination to prior to employment?
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Gmp inspection checklist pdf