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cGMP/GLP/R&D
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Chemic Document Control Outline of Chemic's QC/QA Manual 1.0 Scope ..............................................................Commitment to Quality 2.0 Table of Contents ...........................................Quick Reference Outline 3.0 Introduction......................................................Chemic History 4.0 References.......................................................Test Methods 5.0 Definitions........................................................Definitions 6.0 Organization & Management..........................Structure & Responsibilities 7.0 Quality Systems, Audit & Review ..................Documentation of Policy & Procedure 8.0 Personnel..........................................................Job Descriptions & Training 9.0 Accommodation and Environment..................Controlled Access 10.0 Facilities & Equipment..................................Descrip.of Facilities & Equip. 11.0 Handling of Test Chemicals.........................Test Chemical Control Procedure 12.0 Reference Chemicals....................................Quality Ref. Chemicals & Reagents 13.0 Measurement Traceability & Calibration....Stability Checks, Certificates 14.0 Test Methods.................................................Method Development 15.0 Quality Control / Quality Assurance.............Internal QC Checks 16.0 Records..........................................................Document Control 17.0 Certificates & Reports..................................Report Contents 18.0 Sub Contracting Testing................................Procedures for SubContracting 19.0 Outside Support & Supplies..........................Balances, Water Testing 20.0 Complaints.....................................................Audits in Response/Complaints Standard Operating Procedures Outline of Chemic's SOP Manual
1.0 Quality Assurance Procedures 2.0 Test Chemical Procedures 3.0 Health and Safety Procedures 4.0 Instrument and Equipment Procedures 5.0 Laboratory Procedures 6.0 Calculations / Data Interpertation / Reporting 7.0 Computer / Data Acquisition 8.0 Project - Specific Procedures |
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*Lauryl Lactate
Extractables & Leachables Analysis
Bioanalytical Sample Analysis Methods Dev., & Validation
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