Topic Replies Activity
Instructions Before You Start - Must Read 1 March 4, 2016
Product mix up in visual inspection area 5 April 3, 2020
Dissolution study 1 April 3, 2020
Check leakage filter BIBO HEPA 1 April 3, 2020
Pressure and Passivation Testing in the Qualifications
GMP
1 April 2, 2020
Vitamin c calculation 1 April 2, 2020
Pharmaceutical water validation 1 April 2, 2020
Regarding rhubarb analysis by BP Monograph 1 April 1, 2020
Cleaning validation in FDA plant 1 April 1, 2020
Microbiology efficacy of hand sanitizer 1 April 1, 2020
Swab sampling after cleaning 4 April 1, 2020
Usp 41 microbiology topic 5 April 1, 2020
Reference standard and working standard 1 March 31, 2020
Shelf life extrapolation based on stability studies data 1 March 31, 2020
Shelf life of product/ material 3 March 31, 2020
Should we use stability indicative methods in Stability Analysis, even though official Pharmacopeia Method adopted 1 March 31, 2020
Document Retention period 5 March 31, 2020
Multiple Batches 1 March 31, 2020
Schedule M relating to sanitizer making plant 1 March 30, 2020
Could a R&D (analytical or formulation) personnel avoid wearing cap? what should be then the dress code for R&D? Is R&D a non GMP complied area?
GMP
4 March 30, 2020
Qualification of Cold Storage facility 1 March 30, 2020
Covid 19 or Corona Virus 4 March 30, 2020
Primary packing supplier change and Stability study requirement 2 March 30, 2020
How do I decide on placement of biological indicators within an isolator or autoclave 3 March 28, 2020
Biological Indicators 3 March 27, 2020
Mechanical Engineer 2 March 27, 2020
Expiry date for the raw materials
GMP
7 March 27, 2020
How to dispose bet gel clots after analysis 2 March 26, 2020
API or excipient specification by drug product manufacturer 1 March 26, 2020
Selection of LOD or MC for last inproses test? 9 March 26, 2020

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