Learnaboutgmp Community

Topic	Replies	Views	Activity
Batch size deviation required stabiity GOOD MANUFACTURING PRACTICE (cGMP)	0	920	March 12, 2020
Is A Compressed Air PQ Really Required? GENERAL VALIDATION AND cGMP DEFINITIONS	2	1268	April 13, 2020
Vent Filter Temparature for Purified water storage Tank PURIFIED WATER VALIDATION	4	4893	April 2, 2020
Validation New Equipment EQUIPMENT VALIDATION	5	1866	April 2, 2020
GMP Training GOOD MANUFACTURING PRACTICE (cGMP)	2	1066	March 3, 2020
What is the expectation for storing and archiving data that is generated during a test script? COMPUTER SYSTEM VALIDATION (CSV)	1	1348	February 16, 2020
Water addition under nitrogen atmosphere GOOD VALIDATION PRACTICE (cGVP)	0	796	December 3, 2019
Change of a Reverse Osmosis membrane PURIFIED WATER VALIDATION	4	1173	November 13, 2019
What is the maximum daily dose for topical products? CLEANING VALIDATION	2	1525	October 14, 2019
Performance qualification of dry heat sterilization EQUIPMENT VALIDATION	4	1787	October 2, 2019
Thermoflex Re-ciculating chiller GOOD VALIDATION PRACTICE (cGVP)	0	825	September 20, 2019
0.22 or 0.45 um collection filter for Bacterial retention testing LABORATORY, METHOD AND ANALYTICAL VALIDATION	3	2090	September 27, 2019
Compressed air filter Integrity Testing GOOD MANUFACTURING PRACTICE (cGMP)	3	2594	September 27, 2019
What SOPs needed for BAS qualification SCADA AND PLC's	0	990	September 20, 2019
Mixing tank qualification EQUIPMENT VALIDATION	6	10251	September 19, 2019
Requalification Clean Compressed Air PROCESS VALIDATION	0	1023	September 9, 2019
Cleaning's Validation for alcohol based product CLEANING VALIDATION	4	1339	August 20, 2019
Mixing/Compounding Tank IQ/Commissioning EQUIPMENT VALIDATION	1	1353	July 30, 2019
Automatic visual inspection - Bracketing EQUIPMENT VALIDATION	2	1430	July 30, 2019
HVAC Vaildation HVAC VALIDATION	2	1543	July 17, 2019
Temperature mapping LABORATORY, METHOD AND ANALYTICAL VALIDATION	7	2698	July 5, 2019
Eu fmd REGULATORY TRENDS AND QA	2	1539	May 25, 2019
Safe for use or no CLEANING VALIDATION	1	1194	May 20, 2019
Defining MACO parameters CLEANING VALIDATION	1	1314	May 16, 2019
Use of ‘y-intercept’ statistic in linearity test LABORATORY, METHOD AND ANALYTICAL VALIDATION	7	13143	May 13, 2019
CEHT injectables EQUIPMENT VALIDATION	0	1088	May 13, 2019
Csv GAMP® 5 - GAMP® is owned by ISPE	0	1493	May 2, 2019
Rqualification frequency for freezer, refrigerator GOOD MANUFACTURING PRACTICE (cGMP)	0	1232	April 30, 2019
Compressed air nvpc grades rationale GOOD VALIDATION PRACTICE (cGVP)	0	1028	April 30, 2019
On-line TOC analyzer for analysis reduction GOOD VALIDATION PRACTICE (cGVP)	2	1371	April 9, 2019