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GMP Consulting

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 learn more about our GMP consulting services and how we 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

• Improved structure, processes and procedures internally

 

 

How We Can Help

The ISO 9001 Group understands CFR Part 210 and CFR Part 211 regulations and how to comply with them. Our GMP consulting service provides assistance with FDA registration, pre-audit, FDA inspections and responding to FDA warnings letters. Our GMP consultants will work with you to implement the applicable FDA regulations to ensure effective, efficient and compliant good manufacturing practices.

 

Federal Regulations:

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 GMP consulting service ensures that your manufacturing practices comply with FDA regulations and pass FDA inspections.

 

 

21 CFR Part 210 and CFR Part 211 Overview

Subpart A – General provisions

Subpart B – Organization and Personnel

• Responsibilities of quality control unit

• Personnel qualifications

• Personnel responsibilities

• Consultants

Subpart C – Buildings and Facilities

• Design and construction features

• Lighting

• Ventilation, air filtration, air heating and cooling

• Plumbing

• Sewage and refuse

• Washing and toilet facilities

• Sanitation

• Maintenance

Subpart D – Equipment

• Equipment design, size, and location

• Equipment construction

• Equipment cleaning and maintenance

• Automatic, mechanical, and electronic equipment

• Filters

Subpart E – Control of Components and Drug Product Containers and Closures

• 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

Subpart F – Production and Process Controls

• Written procedures and deviations

• Charge-in of components

• Calculation of yield

• Equipment identification

• Sampling and testing of in-process materials and drug products

• Time limitations on production

• Control of microbiological contamination

• Reprocessing

Subpart G – Packaging and Labeling Control

• 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

• Expiration dating

Subpart H – Holding and Distribution

• Warehousing procedures

• Distribution procedures

Subpart I – Laboratory Controls

• Testing and release for distribution

• Stability testing

• Special testing requirements

• Reserve samples

• Laboratory animals

• Penicillin contamination

Subpart J – Records and Reports

• 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

• Distribution records

• Complaint files

Subpart K – Returned and Salvaged Drug Products

• Returned drug products

• Drug product salvaging

 

Visit the U.S. Food and Drug Administration‘s website to learn more about Good Manufacturing Practice (GMP) regulations.

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