by maheshbhuva | Jun 6, 2023 | Analytical Chemistry, Job in pharmaceutical companies, stability
In the pharmaceutical industry, a “finished product retest” refers to the process of evaluating a sample from a previously manufactured and packaged pharmaceutical product to assess its quality, safety, and efficacy. The purpose of the retest is to ensure...
by maheshbhuva | May 19, 2023 | Analytical Chemistry, stability
Chemical: Each API (active ingredient retains its chemical integrity and labeled potency within the specified limit. Physical: the physical stability properties includes appearance, palatability, uniformity, dissolution and suspend ability are retained....
by maheshbhuva | May 3, 2023 | 483 observation, Analytical Chemistry, Out of specification
Do we need to raise an OOS, if OOS result is observed during API Method transfer First defined which lab mean by At receiving lab At originating lab YES Required Caution: inform API vendor about failure Investigation release analysis Assess impact on DP(drug product)...
by maheshbhuva | Apr 5, 2023 | 621 USP CHAPTER, Analytical Chemistry
All chapter are use full for ADJUSTMENT of chromatography, TLC etc In such case some questions arias that Why adjustment in chromatography ? How adjustment justified ? Adjust chromatography If your method is validated and method are submitted in DMF so...
by maheshbhuva | Mar 16, 2023 | ALCOA++, Analytical Chemistry, QMS
Attributable Mainly to ask of following question is that Who, when, what and why? Who Person has identified When place has identified What event identified Why mean why all the operation will be happen that all example will give as on QMS activity document other...
by maheshbhuva | Feb 11, 2023 | Analytical Chemistry, GMP
â—‹ Whenever supervisor give work allocation for testing any product.â—‹ Then careful read specification(SOP) not missing any point which is defied in sopâ—‹ Before start analysis glassware collect in try â—‹ Labelling of each glassware â—‹ Seen availability chemicals and...
