cGMP Guidelines


USFDA: 

Guidances (Drugs) - Food and Drug Administration

US FDA Title 21 CFR Parts

PART 11

ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

PART 58

GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES22

PART 110

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

PART 111

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

PART 210

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

PART 211

CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS22

PART 600

BIOLOGICAL PRODUCTS: GENERAL22

PART 601

LICENSING BIOLOGICS

PART 606

CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS

PART 610

GENERAL BIOLOGICAL PRODUCTS STANDARDS

PART 700

GENERAL COSMETICS

PART 701

COSMETIC LABELING22

PART 820

QUALITY SYSTEM REGULATION MEDICAL DEVICES


EU


 

WHO

WHO | Norms, standards and guidance for pharmaceuticals

WHO GMP

Biologicals: WHO | Publications and links

Medicines Publications

WHO Technical Report Series

WHO Working Documents (Draft Documents)

 

 

ICH Guidelines

Quality Guidelines

Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.
Zip with all ICH Quality Guidelines in word format

Safety Guidelines

ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.
Zip file with all ICH Safety Guidelines in Word format

Efficacy Guidelines

The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/ pharmacogenomics techniques to produce better targeted medicines.
Zip file with all Efficacy Guidelines in Word format

Multidisciplinary Guidelines

Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).
Zip file with all Multidisciplinary Guidelines in Word format

 

Health Canada


PIC/S GMP GUIDES Publication

China FDA

Japan PMDA

Australia TGA