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Pharmaceutical GMP Professional Certification
References
Code of Federal Regulations 21CFR (including FDA Preamble [Fed Register Vol. 43 No. 190] ) documents
* 210-211 Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding Finished Pharmaceuticals
* Section 7 Recalls (Including Product Corrections)
* Part 11 Electronic Records ; electronicsignatures
* Part 58 Good Laboratory Practices for Non-clinical Laboratory Studies
* 1308.11-1308.15 requirement for storage of controlled substances
* 205 Guidelines for State Licensing of Wholesale Prescription Drug Distributors
Food and Drug Administration (FDA) Guidances
* Changes to an Approved NDA or ANDA
* Container and Closure Integrity Testing in Lieu of Sterility Testingas a Component of the Stability Protocol for Sterile Products
* Container Closure Systems for Packaging Human Drugs and Biologics
* Current Good Manufacturing Practice for Combination Products
* for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
* General Principles of Software Validation
* PowderBlends and Finished Dosage Units--Stratified In-Process Dosage Unit Sampling and Assessment
* Product Recalls, Including Removals and Corrections
* Q1A (R2) Stability Testing of New Drug Substances and Products
* Q1E Evaluation of Stability Data
* Q3B( R) Impurities in New Drug Products
* Quality Systems Approach to Pharmaceutical CGMP Regulations
* Sterile DrugProducts Produced by Aseptic Processing
FDA Guide to Inspections
* Investigations Operations Manual (IOM) 2008
* Microbiological Pharmaceutical Quality Control Laboratories
* Pharmaceutical Quality Control Laboratories
* Topical Drug Products
* Validation of Cleaning Processes
* High Purity Water Systems
* Biotechnology inspection guide reference materials andtraining aids
FDA Guidelines
* Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs 
* Validation of the Limulus Amebocyte Lysate Test
* Inspections of Sterile Drug Substance Manufacturers
* Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and Validation
* Investigating Out of Specification Test Results
* GeneralPrinciples of Process Validation
FDA Policy Guides (Compliance Policy Guides (CPG))
* Preapproval Inspections 7346.832
* Sterile Drug Process Inspections Program 7356.002A
* Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections Program 7356.002
* Compliance Program Guidance Manual 7356.002F Active Pharmaceutical Ingredient (API) Process InspectionPharmaceutical Inspection Convention/Co-operation Scheme (PIC/S)
* PE 008-2 Explanatory Notes for Industry on the Preparation of a Site Master File
* PE 010-3 PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments
* Pl 006-3 Recommendations on Validation Master Plan Installation and Operational Qualification Non-Sterile Process ValidationCleaning Validation
* Pl 007-4 Recommendation on the Validation of Aseptic Processes
* Pl 009-3 Aide-Memoire on Inspection of Utilities
* Pl 010-3 Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects
* Pl 011-3 Good Practices for computerized systems in regulated “GXP” environments
* Pl 012-3 Recommendation on Sterility Testing
* Pl 014-3Recommendation on Isolators Used for Aseptic Processing and Sterility Testing
American National Standards Institute (ANSI)/International Organization for Standards (ISO)
* ANSI/ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
* ISO 19011:2002 Guidelines for Quality and Environmental Management Systems Auditing
* ISO 9001-2000 Quality Management...
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