|
Transit study protocol
|
|
0
|
702
|
February 16, 2013
|
|
Process Validation Addendum
|
|
1
|
1549
|
January 18, 2013
|
|
PQ Validation Next
|
|
2
|
903
|
January 10, 2013
|
|
Sterile Filtration for Viscous Liquid
|
|
5
|
3510
|
January 10, 2013
|
|
PV Summary Report CpK in Excel Format
|
|
0
|
996
|
January 10, 2013
|
|
Process Validation Protocol Supporting Data
|
|
0
|
638
|
January 10, 2013
|
|
Media fill before and after facility shut down
|
|
2
|
2024
|
December 18, 2012
|
|
No Longer 3 Golden Batches, So Just How Many Process Performance Qualification Batche
|
|
0
|
621
|
December 10, 2012
|
|
Validation Plan
|
|
0
|
709
|
December 10, 2012
|
|
Formulation Tips
|
|
3
|
883
|
November 23, 2012
|
|
Sampling plans for validation and acceptence criteria
|
|
1
|
1660
|
November 20, 2012
|
|
Content Uniformity
|
|
1
|
1161
|
November 12, 2012
|
|
Critical Variables Monitoring
|
|
1
|
738
|
November 8, 2012
|
|
Protocol vs. Summary Report Approval
|
|
1
|
613
|
November 6, 2012
|
|
Intermdiate Stability
|
|
6
|
839
|
November 5, 2012
|
|
Process Validation Protocol for Powder/Granules for Oral Suspension
|
|
0
|
1007
|
November 5, 2012
|
|
Application of existing validation data for registering a new product
|
|
0
|
573
|
November 2, 2012
|
|
Granules for oral solutions - process validation
|
|
0
|
574
|
November 1, 2012
|
|
Holding time
|
|
16
|
3161
|
October 23, 2012
|
|
Process Validation Data Analysis?
|
|
2
|
837
|
October 23, 2012
|
|
Change in the API manufacture VS drug product process validation
|
|
4
|
1123
|
October 13, 2012
|
|
Tablet Compression - Increasing Batch Size and Multitip tooling
|
|
1
|
1217
|
October 9, 2012
|
|
Testing amount vs. back-up amount
|
|
0
|
523
|
October 4, 2012
|
|
Sterilization hold time
|
|
0
|
658
|
October 2, 2012
|
|
Process steps to include in process validation
|
|
1
|
751
|
October 1, 2012
|
|
Time-points in Stability Testing
|
|
3
|
2635
|
September 25, 2012
|
|
What is Process Validation?
|
|
4
|
2423
|
September 24, 2012
|
|
Annual Product Quality Review (APQR)
|
|
3
|
4998
|
September 24, 2012
|
|
Drying time management
|
|
4
|
1305
|
September 19, 2012
|
|
Tablet process validation
|
|
16
|
1400
|
September 17, 2012
|