Topic Replies Views Activity
autoclave
PQ (PERFORMANCE QUALIFICATION)
5 2812 February 26, 2021
Steam Sterilization Lethality (Fo) Calculation
PQ (PERFORMANCE QUALIFICATION)
5 11099 February 26, 2021
Software Cannot Be Pre-Validated – Understand Intended Use [Video]
SOFTWARE VALIDATION DOCUMENTATION
0 19 February 18, 2021
Mapping
EQUIPMENT VALIDATION
2 408 February 15, 2021
Which category s/w is it?
GAMP® 5 - GAMP® is owned by ISPE
2 33 February 12, 2021
Unidirectional airflow speed calculation in a laminar flow hood
0 22 February 9, 2021
Engineering
GOOD ENGINEERING PRACTICE (cGEP)
0 42 February 3, 2021
Machine Virtualization for Physical Decommissioning
GAMP® 5 - GAMP® is owned by ISPE
0 43 January 23, 2021
Migrating of Data from Non-Validated System to Validated System
COMPUTER SYSTEM VALIDATION (CSV)
1 482 January 23, 2021
Using a Band-Aid to Explain Validation Efficacy and Usability
GOOD VALIDATION PRACTICE (cGVP)
0 68 January 21, 2021
Understanding Validation and Verification Using a Life Preserver [Video]
GOOD VALIDATION PRACTICE (cGVP)
0 59 January 19, 2021
Are Your Personnel Adhering to CFR 211.28 to Avoid Contamination? [Video]
GOOD MANUFACTURING PRACTICE (cGMP)
0 42 January 19, 2021
Traceability of Design Outputs to Design Inputs a Key Task for MDSAP [Video]
GOOD VALIDATION PRACTICE (cGVP)
0 39 January 19, 2021
Thermocouple placements
0 96 December 13, 2020
Autoclave Qualification: 2K Temperature Difference, & 1K Fluctuation in Empty Chamber Test
EQUIPMENT VALIDATION
1 1471 November 18, 2020
Autoclave Periodic Revalidation Failure
EQUIPMENT VALIDATION
0 193 October 7, 2020
Detection of endotoxin in vial washing M\c
21 CFR PART 11
2 999 August 26, 2020
OQ & PQ of Vial washing Machine
CLEANING VALIDATION
5 1120 August 26, 2020
Haccp
GENERAL VALIDATION AND cGMP DEFINITIONS
3 1717 November 5, 2010
Ask for help of GMP documentations
GOOD MANUFACTURING PRACTICE (cGMP)
2 953 May 29, 2020
Die to Die should be used to validate the CIP process
CLEANING VALIDATION
4 1146 May 22, 2020
Validation of Dry cabinet
GOOD VALIDATION PRACTICE (cGVP)
0 337 May 14, 2020
PQ of compressed air system
GOOD VALIDATION PRACTICE (cGVP)
0 564 March 11, 2020
Batch size deviation required stabiity
GOOD MANUFACTURING PRACTICE (cGMP)
0 537 March 12, 2020
Is A Compressed Air PQ Really Required?
GENERAL VALIDATION AND cGMP DEFINITIONS
2 783 April 13, 2020
Vent Filter Temparature for Purified water storage Tank
PURIFIED WATER VALIDATION
4 3021 April 2, 2020
Validation New Equipment
EQUIPMENT VALIDATION
5 1321 April 2, 2020
GMP Training
GOOD MANUFACTURING PRACTICE (cGMP)
2 730 March 3, 2020
What is the expectation for storing and archiving data that is generated during a test script?
COMPUTER SYSTEM VALIDATION (CSV)
1 925 February 16, 2020
Water addition under nitrogen atmosphere
GOOD VALIDATION PRACTICE (cGVP)
0 499 December 3, 2019