The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
FDA Guidance for Industry: Data Integrity and Compliance with cGMP
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf
Content:
The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others