Source: https://iso9001group.com/good-manufacturing-practices-gmp-consultants/
Timestamp: 2020-08-10 07:43:14
Document Index: 405391738

Matched Legal Cases: ['art 210', 'art 211', 'art 210', 'art 211', 'art 210', 'art 211']

ISO 9001Group | Good Manufacturing Practice GMP Consultants | The ISO 9001 Group
Good Manufacturing Practice (GMP) regulations help the U.S. Food and Drug Administration (FDA) protect consumers by confirming the safety, quality, and efficacy of consumable products. The FDA carefully monitors manufacturers, processors, and packagers of drugs, medical devices, food and cosmetics to ensure consumer safety. The mandated and required GMP regulations cover all aspects of production, including having the necessary facilities, equipment, methods, controls and the ability to manufacture, process, and pack their products.
Contact us today to find out more about how The ISO 9001 Group can assist your organization with GMP compliance.
Benefits of Good Manufacturing Practices (GMPs)
• Ensure consumer safety
• Comply with federal and statutory laws and regulations
• Ensure the safety and efficacy of products
• Reduce consumer risks
• Meet requirements for GMP compliance or certification
The ISO 9001 Group understands CFR Part 210 and CFR Part 211 regulations and how to comply with them. We provide assistance with FDA registration, pre-audit, FDA inspections and responding to FDA warnings letters. Our consultants will work with you to implement the applicable FDA regulations to ensure effective, efficient and compliant good manufacturing practices.
• 21 CFR Part 210. Current Good Manufacturing Practice in Manufacturing Processing, Packing, or Holding of Drugs
• 21 CFR Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals
Our proven, hands-on approach ensures that your manufacturing practices comply with FDA regulations and pass FDA inspections.
21 CFR Part 210 and CFR Part 211 Overview
• Responsibilities of quality control unit
• Design and construction features
• Ventilation, air filtration, air heating and cooling
• Sewage and refuse
• Washing and toilet facilities
• Equipment design, size, and location
• Automatic, mechanical, and electronic equipment
• Receipt and storage of untested components, drug product containers, and closures
• Testing and approval or rejection of components, drug product containers, and closures
• Use of approved components, drug product containers, and closures
• Retesting of approved components, drug product containers, and closures
• Rejected components, drug product containers, and closures
• Drug product containers and closures
• Written procedures and deviations
• Charge-in of components
• Calculation of yield
• Sampling and testing of in-process materials and drug products
• Time limitations on production
• Control of microbiological contamination
• Materials examination and usage criteria
• Labeling issuance
• Packaging and labeling operations
• Tamper-evident packaging requirements for over-the-counter (OTC) human drug products
• Drug product inspection
• Warehousing procedures
• Testing and release for distribution
• Special testing requirements
• Reserve samples
• Penicillin contamination
• Equipment cleaning and use log
• Component, drug product container, closure, and labeling records
• Master production and control records
• Batch production and control records
• Production record review
• Laboratory records
• Returned drug products
• Drug product salvaging
Visit the U.S. Food and Drug Administration‘s website to learn more about Current Good Manufacturing Practice (CGMP) regulations.