Research ArticlePDA Papers
PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections
Deb Autor, Zena Kaufman, Ron Tetzlaff, Maryann Gribbin, Madlene Dole, Derek Glover, Brad Mercer, Doreen Newhouse, Jackie Veivia-Panter, Anil Sawant and Denyse Baker
PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 332-337; DOI: https://doi.org/10.5731/pdajpst.2018.008573
Deb Autor
Mylan
Zena Kaufman
ZGK Quality Consulting
Ron Tetzlaff
PAREXEL International
Maryann Gribbin
Faith and Royale Consultants
Madlene Dole
Novartis
Derek Glover
Mylan
Brad Mercer
Avantor Inc.
Doreen Newhouse
Bridge Associates International LLC
Jackie Veivia-Panter
Celgene
Anil Sawant
Merck
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 3
May/June 2018
PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections
Deb Autor, Zena Kaufman, Ron Tetzlaff, Maryann Gribbin, Madlene Dole, Derek Glover, Brad Mercer, Doreen Newhouse, Jackie Veivia-Panter, Anil Sawant, Denyse Baker
PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 332-337; DOI: 10.5731/pdajpst.2018.008573
PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections
Deb Autor, Zena Kaufman, Ron Tetzlaff, Maryann Gribbin, Madlene Dole, Derek Glover, Brad Mercer, Doreen Newhouse, Jackie Veivia-Panter, Anil Sawant, Denyse Baker
PDA Journal of Pharmaceutical Science and Technology May 2018, 72 (3) 332-337; DOI: 10.5731/pdajpst.2018.008573
Jump to section
- Article
- Abstract
- Background and Purpose
- Question 1: Copies of Good Manufacturing Practice (GMP) Records
- Question 2: Documents Not Traditionally Considered GMP Records
- Question 3: Personal Diaries
- Question 4: Drafts of GMP Documents
- Question 5: E-mails as GMP Records
- Question 6: Business Records That Are Not GMP Records
- Question 7: Use of Shredders
- Question 8: Retention of Closed Circuit Television (CCTV)
- Question 9: Data Capture Capabilities
- Question 10: Quality Plans
- Question 11: Questioning Investigator Actions in the Field
- Conclusion
- Conflict of Interest Statement
- References
- Info & Metrics
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