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[DOC File]Standard operating procedures (SOP) - Back Bone of ...
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A typical Pharmaceutical Industry has an average of 1200- 1300 SOPs. A Parenteral Drug Association (PDA) survey found that a typical pharmaceutical company must manage an average of 1250 CGMP …
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[DOC File]USER REQUIREMENTS TEMPLATE
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The wide range filler shall be designed to meet the appropriate GMP regulations including cGMP 21 CFR part 210 and 211 as published at the time of order. ... Training. User training shall consist of 8 hours of classroom training and 16 hours of equipment training.
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[DOC File]Audit Report with GMP Questionnaire
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Training 15. 5.8. Cleaning 15. 6. Audit Observations 15 ... qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable …
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[DOC File]Internal Audit Template
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Building Exterior and surrounding area is free from potential food contaminants. Building Interior is sound and free from potential food contaminants. Sanitary Facilities are in good working order and stocked …
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[DOCX File]Method of Removal / Dismissal
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Safety/cGMP Training Policy. Due to the technical hands-on experience required during the program, it is important for the Phlebotomy students to have documented safety training. LPS will provide such a training …
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[DOC File]Quality Assurance Plan Checklist - HUD
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9.0 Training To be completed by Author To be completed by Reviewer REQUIREMENT AUTHOR X REFERENCE Page #/Section # AUTHOR COMMENTS COMPLY REVIEWER COMMENTS Y N 1.0 …
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[DOC File]Overall PAI Readiness:
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( ( ( A written training procedure is available and it is followed. ( ( ( Personnel records indicate they have appropriate education, training, and experience to perform assigned functions. ( ( ( Personnel training records include documentation of cGMP orientation and ongoing cGMP training according to training …
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