Dietary Supplement Good Manufacturing Practices

Dietary Supplement Good Manufacturing Practices

Preparing for Compliance

Mead, William J.

Taylor & Francis Ltd

10/2024

312

Mole

9781032922522

Pré-lançamento - envio 15 a 20 dias após a sua edição

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The Basics of Good Manufacturing Practice. Regulatory Overview. Personnel Matters. Physical Plant and Grounds. Equipment and Utensils. Cleaning and Sanitation. Maintenance and GMP. Calibration. Production and Process Controls. Specifications. Sampling. Deviations and Corrective Actions. Incoming Components, Packaging Materials and Labels. Master Manufacturing Record. Batch Production Record. Manufacturing Operations. Packaging and Labeling Operations. Quality Control Responsibilities. Laboratory Operations. Returned Goods. Product Complaint Handling. Holding and Distributing. Handling Recalls. Top Management Responsibility. Record Keeping, Documentation, SOPs. Change Control. Adverse Event Reporting and Records Keeping. Continuous Improvement. Supply Chain Integrity. Audits. Outsourcing. The FDA. FDA Inspections.
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Dietary Supplement Good Manufacturing Practices;Dietary Supplement;The Basics of Good Manufacturing Practice;Quality Control Personnel;Physical Plant and Grounds;Dietary Supplement Product;Holding and Distributing;Dietary Supplement GMPs;Top Management Responsibility;Dietary Ingredients;Supply Chain Integrity;GMP Regulation;CFR;PDA;FDA Inspection;Investigations Operations Manual;Follow;Preamble;Dietary Supplement Manufacturing;Disposition Decisions;Finished Batches;NSF International;ASQ;OTC Drug;Raton;Good Manufacturing Practice;Contact Surfaces;DS Product;In-process Specifications;Batch Production Records