Learnaboutgmp Community

Topic	Replies	Views	Activity
Risk Assessment H2O2 Isolator vor Validation GENERAL VALIDATION AND cGMP DEFINITIONS	0	404	March 24, 2021
How should I determine MACO formula for Topical Solution? CLEANING VALIDATION	0	534	March 9, 2021
Steam Sterilization Lethality (Fo) Calculation PQ (PERFORMANCE QUALIFICATION)	5	12838	February 26, 2021
Software Cannot Be Pre-Validated – Understand Intended Use [Video] SOFTWARE VALIDATION DOCUMENTATION	0	377	February 18, 2021
Mapping EQUIPMENT VALIDATION	2	709	February 15, 2021
Which category s/w is it? GAMP® 5 - GAMP® is owned by ISPE	2	447	February 12, 2021
Engineering GOOD ENGINEERING PRACTICE (cGEP)	0	432	February 3, 2021
Machine Virtualization for Physical Decommissioning GAMP® 5 - GAMP® is owned by ISPE	0	334	January 23, 2021
Migrating of Data from Non-Validated System to Validated System COMPUTER SYSTEM VALIDATION (CSV)	1	826	January 23, 2021
Using a Band-Aid to Explain Validation Efficacy and Usability GOOD VALIDATION PRACTICE (cGVP)	0	410	January 21, 2021
Understanding Validation and Verification Using a Life Preserver [Video] GOOD VALIDATION PRACTICE (cGVP)	0	367	January 19, 2021
Are Your Personnel Adhering to CFR 211.28 to Avoid Contamination? [Video] GOOD MANUFACTURING PRACTICE (cGMP)	0	362	January 19, 2021
Traceability of Design Outputs to Design Inputs a Key Task for MDSAP [Video] GOOD VALIDATION PRACTICE (cGVP)	0	313	January 19, 2021
Thermocouple placements	0	359	December 13, 2020
Autoclave Qualification: 2K Temperature Difference, & 1K Fluctuation in Empty Chamber Test EQUIPMENT VALIDATION	1	1826	November 18, 2020
Autoclave Periodic Revalidation Failure EQUIPMENT VALIDATION	0	619	October 7, 2020
Detection of endotoxin in vial washing M\c 21 CFR PART 11	2	1386	August 26, 2020
OQ & PQ of Vial washing Machine CLEANING VALIDATION	5	1618	August 26, 2020
Haccp GENERAL VALIDATION AND cGMP DEFINITIONS	3	2031	November 5, 2010
Ask for help of GMP documentations GOOD MANUFACTURING PRACTICE (cGMP)	2	1222	May 29, 2020
Die to Die should be used to validate the CIP process CLEANING VALIDATION	4	1495	May 22, 2020
Validation of Dry cabinet GOOD VALIDATION PRACTICE (cGVP)	0	589	May 14, 2020
PQ of compressed air system GOOD VALIDATION PRACTICE (cGVP)	0	831	March 11, 2020
Batch size deviation required stabiity GOOD MANUFACTURING PRACTICE (cGMP)	0	773	March 12, 2020
Is A Compressed Air PQ Really Required? GENERAL VALIDATION AND cGMP DEFINITIONS	2	1082	April 13, 2020
Vent Filter Temparature for Purified water storage Tank PURIFIED WATER VALIDATION	4	3914	April 2, 2020
Validation New Equipment EQUIPMENT VALIDATION	5	1667	April 2, 2020
GMP Training GOOD MANUFACTURING PRACTICE (cGMP)	2	951	March 3, 2020
What is the expectation for storing and archiving data that is generated during a test script? COMPUTER SYSTEM VALIDATION (CSV)	1	1148	February 16, 2020
Water addition under nitrogen atmosphere GOOD VALIDATION PRACTICE (cGVP)	0	688	December 3, 2019