The Food and Drug Administration (FDA) issues Good Manufacturing Practices (GMP) for the various industries that fall under its purview. The GMPs or Quality System Regulations are meant to ensure that the products these industries manufacture are safe, effective and meet quality requirements of the FDA.
A medical device data system (MDDS) is a system intended to provide one or more of the following uses:
- Pharmaceuticals
- Medical Devices
- Food
- Cosmetics
- Dietary Supplements
- Biologics
Learn about the FDA’s cGMP guidelines and how to prepare for cGMP audits. Read More >>
FDA GMP Guidelines for Pharmaceutical Drugs
The aim of the FDA cGMP guidelines program for pharmaceuticals is to establish a 21st century, risk based approach to the manufacture of drugs. The FDA GMP Guidelines for drugs cover different areas of drug manufacture including:
- Calibration of apparatuses
- Aseptic processing
- Drug exports
- Quality systems approach to cGMP
- Early phase investigative drugs (IND)
- Process validation
- Donation of prescription drugs to free clinics
- Dosage units
- Pharmacy compounding
- Pharma development and manufacturing
- Active pharmaceutical ingredients manufacture
- Investigating Out of Specification test results for pharma manufacture
- Computer systems
- Electronic records and signatures
The FDA expects drug manufacturers to use these guidelines as a knowledge resource on how best to use certain processes and systems to ensure the optimum results and produce high quality, safe and effective drugs.
To understand how to comply with FDA GMP Guidelines for early phase investigative drugs or IND, Read More >>
FDA GMP Guidelines for Medical DevicesAs medical devices become increasingly ubiquitous and available for home use, it has become imperative for device manufacturers to produce safe and easy to use products. The FDA cGMP Guidelines for Medical Devices are covered in CFR Part 820. They cover such medical device related topics as:
- Management responsibility
- Quality audits
- Personnel
- Design controls
- Document controls
- Purchasing controls
- Identification and traceability
- Production and process controls, including validation
- Acceptance activities
- Non-conforming products
- CAPA
- Labeling and packaging control
- Handling, storage, distribution and installation
- Records including Device Master Records (DMRs), Device History Records (DHRs), Quality System Records, Complaint Files
- Servicing
- Statistical techniques
To gain a better understanding of the FDA GMP Guidelines and Quality System Regulations for medical devices, Read More >>
FDA GMP Guidelines for Food
Food safety and quality is an important regulatory issue and the FDA GMP Guidelines act as an important resource for manufacturers on the best way they can ensure their products are safe for consumption.
The FDA cGMP Guidelines for Food, detailed in 21 CFR Part 110, cover the following processes and systems:
- Personnel
- Building and facilities (sanitation requirements, plant construction)
- Equipment and utensils
- Production and process controls
- Defect action levels
Understand the FDA GMP requirements for food contact packaging – Read More >>
FDA GMP Guidelines for Cosmetics
While the FDA doesn't issue specific regulations related to the production of cosmetics – it is a self-regulating industry – it does issue cGMP Guidelines and checklists that manufacturers should use as a resource for a better understanding of best practices.
The FDA cGMP Guidelines for cosmetics cover the following processes and systems:
- Building and facilities
- Equipment
- Personnel
- Raw material
- Production
- Laboratory controls
- Records
- Labeling
- Complaint files
How do you test raw materials for micro-organisms when manufacturing cosmetics and ensure you comply with FDA GMP Guidelines?, Read More >>
FDA GMP Guidelines for Dietary Supplements
The FDA cGMP guidelines for dietary supplements ensure that proper controls are in place for dietary supplements so that they are processed in a consistent manner, and meet quality standards. They apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the U.S.
The FDA GMP guidelines are necessary to ensure that dietary supplements are manufactured consistently as to identity, purity, strength, and composition. They include provisions related to:
- The design and construction of physical plants that facilitate maintenance
- Cleaning
- Proper manufacturing operations
- Quality control procedures
- Testing final product or incoming and in-process materials
- Handling consumer complaints
- Maintaining records
FDA GMP Guidelines for Biologics
Biologics have to be manufactured in accordance with the FDA GMP Guidelines for drugs and medical devices. Additional requirements are included in 21 CFR Parts 600-680. These include requirements related to:
- Personnel
- Establishment standards and maintenance
- Retention samples
- Reporting of biological product deviations by manufacturers
- Transportation of biologics
- Reporting of adverse experiences
- Sterility
- Purity
- Potency
- Equivalent methods and processes
- Testing
- Labeling
To understand the differences between FDA GMP Guidelines for drugs and biologics, Read More >>
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