2012 Software


Top GMP ERP Software

GMP Compliance

GMP, also known as cGMP, stands for current Good Manufacturing Practices, and is a set of regulations set forth by the U.S. Food and Drug Administration (FDA) to help ensure that various products intended for human consumption and use are safe and effective.

cGMP regulations mandate a quality-related methodology to manufacturing - enabling businesses to minimize product contamination, mislabelling and other errors. This protects the consumer from purchasing a product that may be effective or even dangerous.

GMP is part of a quality system covering the manufacture and testing of pharmaceutical dosage forms or drugs and active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries now require that pharmaceutical and medical device companies must follow GMP regulations, and have created their own GMP guidelines.

Most of the GMP regulations address issues such as sanitation, process validation, equipment and document traceability, and personnel qualification. Failure of firms to comply with GMP regulations can result in product recall or seizure, fines and prison.

Industries Effected Under 21 CFR

The following industries are impacted under the FDA Good Manufacturing Practices (GMP) regulations:

Pharmaceuticals Industry (21 CFR Parts 210, 211, 212)

Dietary Supplements Industry (21 CFR Part 111)

Medical Devices Industry (21 CFR Part 820)

Biotech and Blood Industry (21 CFR Part 606)

Food Industry (21 CFR Part 110)

Animal Drug and Feed Industry (21 CFR Part 225)

Cosmetics Industry (ISO 22716)

Food GMP: FDA 21 CFR Parts 110, 111

These cGMP regulations effects the food industry and complements the HACCP (Hazard Analysis Critical Control Points) program. 21 CFR Part 110 deals largely with food sanitation, food handling and food preparation issues.

21 CFR Part 111 effects the dietary supplement industry and deals with the manufacturing, processing and holding of these substances. Although dietary supplements are regulated by the FDA as foods, they are regulated differently from other foods and from drugs.

FDA 21 CFR Part 110

CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD

Subpart A--General Provisions
Subpart B--Buildings and Facilities
Subpart C--Equipment
Subpart E--Production and Process Controls
Subpart G--Defect Action Levels

FDA 21 CFR Part 111

CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

Subpart A--General Provisions
Subpart B--Personnel
Subpart C--Physical Plant and Grounds
Subpart D--Equipment and Utensils
Subpart E--Requirement to Establish a Production and Process Control System
Subpart F--Production and Process Control System: Requirements for Quality Control
Subpart G--Production & Process Control System: Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement
Subpart H--Production & Process Control System: Requirements for the Master Manufacturing Record
Subpart I--Production and Process Control System: Requirements for the Batch Production Record
Subpart J--Production and Process Control System: Requirements for Laboratory Operations
Subpart K--Production and Process Control System: Requirements for Manufacturing Operations
Subpart L--Production & Process Control System: Requirements for Packaging & Labeling Operations
Subpart M--Holding and Distributing
Subpart N--Returned Dietary Supplements
Subpart O--Product Complaints
Subpart P--Records and Recordkeeping

Pharmaceutical GMP: FDA 21 CFR Parts 210, 211

These cGMP regulations effects the pharmaceutical and drug-related industry. CFR Part 210 deals with the manufacturing, processing and holding of drugs, while CFR Part 211 deals with finished pharmaceuticals.

FDA 21 CFR Part 210

CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL

FDA 21 CFR Part 211

CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Subpart A--General Provisions
Subpart B--Organization and Personnel
Subpart C--Buildings and Facilities
Subpart D--Equipment
Subpart E--Control of Components and Drug Product Containers and Closures
Subpart F--Production and Process Controls
Subpart G--Packaging and Labeling Control
Subpart H--Holding and Distribution
Subpart I--Laboratory Controls
Subpart J--Records and Reports
Subpart K--Returned and Salvaged Drug Products

21 CFR Part 212

Good Manufacturing Practices for Positron Emission Tomography (PET) Drugs

Blood GMP: FDA 21 CFR Part 606

This cGMP regulation affects the biotech and blood industry, including tissue and blood collection, handling, analysis and transfusion products.

CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
Subpart A--General Provisions
Subpart B--Organization and Personnel
Subpart C--Plant and Facilities
Subpart D--Equipment
Subpart F--Production and Process Controls
Subpart G--Finished Product Control
Subpart H--Laboratory Controls
Subpart I--Records and Reports

Medical Device GMP: FDA 21 CFR Part 820

This cGMP regulation effects the medical equipment and medical devices industry.

MEDICAL DEVICES QUALITY SYSTEM REGULATION
Subpart A--General Provisions
Subpart B--Quality System Requirements
Subpart C--Design Controls
Subpart D--Document Controls
Subpart E--Purchasing Controls
Subpart F--Identification and Traceability
Subpart G--Production and Process Controls
Subpart H--Acceptance Activities
Subpart I--Nonconforming Product
Subpart J--Corrective and Preventive Action
Subpart K--Labeling and Packaging Control
Subpart L--Handling, Storage, Distribution, and Installation
Subpart M--Records
Subpart N--Servicing
Subpart O--Statistical Techniques


Animal Drug GMP: FDA 21 CFR Part 225

This cGMP regulation affects the animal drug and medicated animal feed industry.

CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
Subpart A - General Provisions
Subpart B - Construction and Maintenance of Facilities and Equipment
Subpart C - Product Quality Control
Subpart D - Packaging and Labeling
Subpart E - Records and Reports
Subpart F - Facilities and Equipment
Subpart G - Product Quality Assurance
Subpart H - Labeling
Subpart I - Records