resources

Pharmaceutical Inspection Convention PIC/S

Global Harmonization Task Force

Parenteral Drug Association

International Society for Pharmaceutical Engineering ISPE

Singapore - Health Science Authority (HSA)

Indonesia - www.pom.go.id

Malaysia - National Pharmaceutical Control Bureau/Biro Pengawalan Farmaseutikal Kebangsaan

Thailand - Food and Drug Administration

Philippines - www.bfad.gov.ph 

China - 国家食品药品监督管理局 (SFDA)

USA - Food and Drug Administration

• Bioresearch Monitoring Inspections Of In Vitro Diagnostic Devices

• Biotechnology Inspection Guide (11/91)

• Blood Banks (9/94)

• Bulk Pharmaceutical Chemicals (9/91)

• Complete List of FDA investigators Inspection Guides

• Computerized System In The Food Processing Industry

• Dosage Form Drug Manufacturers - Cgmp's (10/93)

• General Principles of Software Validation

• Glossary Comp. Systems. Software Development Terminology (8/95)

• Guidance for Off-the-Shelf Software Use in Medical Devices; (9/99)

• Guide To Inspection Of Computerized Systems In Drug Establishments (2/83)

• Guide To Inspection Of Electromagnetic Compatibility Aspects Of Medical Device Quality Systems

• Guide To Inspections Of High Purity Water Systems

• Guide To Inspections Validation Of Cleaning Processes

• High Purity Water Systems (7/93)

• Infectious Disease Marker Testing Facilities (6/96)

• Lyophilization Of Parenterals (7/93)

• Mammography Quality Standards Act Auditor's Guide

• Medical Device Manufacturers

• Microbiological. Pharmaceutical Quality Control Labs (7/93)

• Oral Solid Dosage Forms Pre/post Appr. Issues (1/94)

• Oral Solutions And Suspensions (8/94)

• Pharmaceutical Quality Control Laboratories (7/93)

• Sterile Drug Substance Manufacturers (7/94)

• Topical Drug Products (7/94)

• U.S. Fda Inspector's Technical Guide

• U.S.FDA Inspection References

• Validation Of Cleaning Processes (7/93)

• Viral Clearance Processes For Plasma Derivatives