Self inspection as per 21CFR part 211
|
|
2
|
169
|
August 9, 2025
|
What is the difference (use ,structure, advantages - disadvantages)between Isolator and RABS in drug product mamufacturing?
|
|
2
|
61
|
April 2, 2025
|
Stray in Hallway/Corridor
|
|
0
|
30
|
March 14, 2025
|
Raw material dispensing
|
|
4
|
449
|
December 12, 2024
|
Reprocessing/ reworking medicianl product
|
|
0
|
93
|
October 9, 2024
|
Is it possible to perform thermal mapping without starting from scratch?
|
|
0
|
296
|
May 10, 2024
|
Steroid & non steroid
|
|
6
|
1344
|
March 26, 2024
|
FALSIFICATION in Formulation Area
|
|
3
|
912
|
November 6, 2023
|
Visual/Description/Appearance data recording
|
|
2
|
539
|
November 2, 2023
|
After filling BPT fail what to do?
|
|
0
|
563
|
October 18, 2023
|
Equipment change in facility
|
|
4
|
1405
|
September 29, 2023
|
Contract Manufacturing
|
|
3
|
710
|
September 16, 2023
|
The situation of Continuous Particle count monitoring in Grade A area in case of aseptically filling a powdery product
|
|
0
|
491
|
August 16, 2023
|
Difference between Batch no. & Lot no
|
|
7
|
21828
|
August 8, 2023
|
Short note of GMP
|
|
0
|
934
|
August 3, 2023
|
Working standard selection criteria
|
|
2
|
622
|
April 16, 2023
|
Good documentation practices
|
|
2
|
1564
|
April 13, 2023
|
Combutible dust risk assessment
|
|
0
|
387
|
March 29, 2023
|
Process Validation using different lots of API
|
|
17
|
9016
|
November 25, 2022
|
Weight variation of tablet & capsule
|
|
5
|
8999
|
October 19, 2022
|
When Copying Documents - Good Documentation Practices
|
|
0
|
779
|
October 18, 2022
|
YouTube resources for Pharma
|
|
2
|
773
|
October 13, 2022
|
Personnel and materials flow
|
|
3
|
1774
|
October 8, 2022
|
Documentaion and records
|
|
7
|
1691
|
October 2, 2022
|
Existing Cephalosporin facility for manufacturing other types of normal product (e.g. Tablets, liquids)
|
|
3
|
768
|
September 10, 2022
|
Target Tablet Weight for Compression (Adjustment based on IPQC Assay)
|
|
0
|
884
|
September 10, 2022
|
Delivery Note in GMP
|
|
0
|
634
|
June 15, 2022
|
Air filters replacement frequency for 10micron and .2micron filters
|
|
0
|
703
|
May 19, 2022
|
Passivation of Production equipment parts (Stainless steel)
|
|
0
|
611
|
March 10, 2022
|
PIC/S GMP Guide (PE 009-16) (Annexes) published 1 February 2022
|
|
0
|
1916
|
February 16, 2022
|