Learnaboutgmp Community

Topic	Replies	Views	Activity
Lyophilizer qualification - pq protocol GOOD MANUFACTURING PRACTICE (cGMP)	0	1166	January 14, 2019
Release Notes Assessment GOOD DOCUMENTATION PRACTICE (GDocP)	0	944	January 17, 2019
Inprocess test covers for OOS investigation as per MHRA GOOD LABORATORY PRACTICE (cGLP)	0	906	January 15, 2019
Electronic Audit trail cheklist GOOD LABORATORY PRACTICE (cGLP)	0	1033	January 14, 2019
PDA Technical Report 3, Revised 2013 REGULATORY TRENDS AND QA	2	4021	January 14, 2019
Mixing after coating GOOD MANUFACTURING PRACTICE (cGMP)	3	1256	January 14, 2019
Sieve and screen qualifications GOOD MANUFACTURING PRACTICE (cGMP)	0	1101	January 9, 2019
Audit Trail - Shall the Audit Trail Keep the Record of the Access Attempt By COMPUTER SYSTEM VALIDATION (CSV)	2	1349	January 4, 2019
Stainless Steel Plate for Swab Recovery CLEANING VALIDATION	6	5231	December 26, 2018
Fluid Bed Dryer and Ethanol Content GOOD MANUFACTURING PRACTICE (cGMP)	6	1426	December 22, 2018
Validation of Needle Tip damage vision system GOOD VALIDATION PRACTICE (cGVP)	0	789	December 18, 2018
Qualification of legacy utility and equipment EQUIPMENT VALIDATION	0	1082	December 18, 2018
Validation on Dummy Environment COMPUTER SYSTEM VALIDATION (CSV)	0	1111	December 10, 2018
Open Vs Closed System COMPUTER SYSTEM VALIDATION (CSV)	6	12551	December 7, 2018
HEPA Certification Under Grade A GOOD MANUFACTURING PRACTICE (cGMP)	1	1249	December 6, 2018
What Do The cGMPs Mean By Separate Facilities? GOOD MANUFACTURING PRACTICE (cGMP)	18	7856	December 4, 2018
FBD & RMG Capacity TEMPLATES & PRESENTATIONS	3	20116	November 29, 2018
WFI distribution system 121 C hot water sanitization EQUIPMENT VALIDATION	1	1811	November 21, 2018
Autoclaving equipment using Steam/Air mixture EQUIPMENT VALIDATION	8	2793	November 16, 2018
Autoclave Qualification Acceptance Criteria EQUIPMENT VALIDATION	9	5204	November 16, 2018
Capacity calculation EQUIPMENT VALIDATION	0	1138	November 14, 2018
Vacuum pump Performance Qualification EQUIPMENT VALIDATION	2	2749	November 14, 2018
Membrane 0.2 micron filter for compressed air GOOD VALIDATION PRACTICE (cGVP)	1	969	November 12, 2018
Compressed Air for Pharma Plant GOOD MANUFACTURING PRACTICE (cGMP)	24	14123	November 10, 2018
Repetitive Deviation DEVIATION AND DISCREPANCY HANDLING	3	2122	November 10, 2018
Perforated SS 316 Plate Screen qualification GOOD MANUFACTURING PRACTICE (cGMP)	0	994	November 10, 2018
What do you do when a critical deviation is performed? DEVIATION AND DISCREPANCY HANDLING	1	1096	November 9, 2018
Manufacturing Execution Systems (MES) & Validation COMPUTER SYSTEM VALIDATION (CSV)	5	3039	October 17, 2018
Stability study requirement-API GOOD MANUFACTURING PRACTICE (cGMP)	1	1437	September 17, 2018
DIP - Deviation investigation protocol: responsibilities DEVIATION AND DISCREPANCY HANDLING	17	2877	August 28, 2018