|
Temperature excursion study
|
|
1
|
634
|
March 2, 2025
|
|
Process Validation
|
|
3
|
55
|
February 28, 2025
|
|
Deviation or Incidence?
|
|
2
|
183
|
January 5, 2025
|
|
Can we use material after sterilization reset temperature in autoclave cycle?
|
|
3
|
83
|
December 24, 2024
|
|
Should this be a deviation? Why or why not
|
|
2
|
107
|
December 24, 2024
|
|
Need of change control for new facility
|
|
3
|
142
|
November 27, 2024
|
|
Process validation
|
|
3
|
179
|
November 27, 2024
|
|
Specimen signature
|
|
4
|
768
|
November 27, 2024
|
|
Criteria and selection of Sampling location and no of samples for cleaning validation in isolator for Onco products
|
|
1
|
512
|
November 27, 2024
|
|
Annexure of SOP
|
|
2
|
112
|
November 26, 2024
|
|
Was data integrity breached?
|
|
4
|
154
|
October 17, 2024
|
|
Risk analysis for other machine use use for capsule filling
|
|
1
|
965
|
October 14, 2024
|
|
Stability Study
|
|
0
|
226
|
October 9, 2024
|
|
What is the latest who gmp guidance on raw material sampling approach
|
|
2
|
417
|
September 16, 2024
|
|
A Harmonized Lable for storage condition of API shipments
|
|
1
|
244
|
September 2, 2024
|
|
Cleaning validation
|
|
1
|
583
|
August 14, 2024
|
|
Supply chain of finished product
|
|
3
|
857
|
July 30, 2024
|
|
Risk Assessment on HPLC Calibration frequency
|
|
0
|
381
|
July 29, 2024
|
|
Stamping of 'Uncontrolled copy' stamp on documents submission to DCA/CDSCO
|
|
1
|
402
|
July 1, 2024
|
|
Product Quality Review (PQR)
|
|
0
|
583
|
July 2, 2024
|
|
Raw Materials_Retesting_Extension of Shelf life
|
|
6
|
3095
|
June 11, 2024
|
|
In process control
|
|
0
|
484
|
June 9, 2024
|
|
Standard batch size
|
|
5
|
1092
|
June 2, 2024
|
|
Change over clearance
|
|
2
|
469
|
June 2, 2024
|
|
Internal audit evaluation
|
|
2
|
457
|
June 2, 2024
|
|
Security test bob
|
|
0
|
243
|
May 30, 2024
|
|
Security Test alice
|
|
0
|
237
|
May 30, 2024
|
|
Can we divided a single SOP in two parts through change control
|
|
2
|
497
|
May 27, 2024
|
|
Qualification Supplier
|
|
1
|
409
|
May 27, 2024
|
|
Manufacturing date for reprocess batch
|
|
2
|
3111
|
May 14, 2024
|