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Details
Applied Risk Management for Commissioning and Qualification
Heating, Ventilation and Air conditioning (HVAC)
PQLI - Part 1 - Product Realization using Quality by design (QbD): Concepts & Principles
Good Engineering Practice
Packaging, labeling, and warehousing facilities
Ozone sanitization of pharmaceutical water systems
Assessing the particulate containment performance of pharmaceutical equipment
Technology transfer
Gamp - A risk based approach to calibration management (2nd edition)
Part-2 - Product realization using quality by design (QbD) : illustrative example (PQLI)
Commissioning and Qualification of pharmaceutical water and steam systems
Vol-3 - Sterile product manufacturing facilities - second edi. / sept. 2011
Gamp - Electronic data archiving
IT infrastructure control and compliance
Gamp-5 - A risk based approach to compliant GxP computerized systems
Vol-1 - Active pharmaceutical ingredients - second ed / June 2007
Gamp - A risk based approach to GxP Compliant Laboratory Computerized Systems
Vol-2 - Oral Solid Dosage Forms - Second Ed. / Nov. 2009
Process Gases
Maintenance
Gamp - A risk based approach to operation of GxP computerized systems
Vol. 4 - Water and steam systems - second ed. / Dec. 2011
A risk based approach to compliant electronic records and signature
Pharmaceutical engineering guides for new and renovated facilities