What is Out of-Specification Investigation and How to Proceed for it?
Veeprho Laboratories Pvt.Ltd
by Venkat Shinde
3y ago
Background: FDA issued warning letter to the most of the drug substance and drug product manufacturer. During the inspection, FDA find out the fault, the way investigation of ..read more
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Overview of Scale-Up and Post-Approval Changes (SUPAC)
Veeprho Laboratories Pvt.Ltd
by ashwini
3y ago
Introduction: The development of increase in batch size from small scale to large scale is termed as scale-up. This process is required in-depth study and knowledge ..read more
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Regulatory Requirement for Stability Study
Veeprho Laboratories Pvt.Ltd
by ashwini
3y ago
Introduction: Pharmaceutical products shelf-life estimation by assessing through systematic stability study is regulatory requirement, during this review current regulatory requirements elaborated. The main aim of this ..read more
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Assessment of USFDA Warning Letters & 483’s Related to Improper Handling of OOS Results
Veeprho Laboratories Pvt.Ltd
by Venkat Shinde
3y ago
Introduction The US Food and Drug Administration (FDA) inspection trend of recent warning letters is typically related to deficient investigation of failure results, unacceptable examination of ..read more
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Analytical Method Development Approach When Compound Don’t Have UV Chromophore:
Veeprho Laboratories Pvt.Ltd
by Venkat Shinde
3y ago
High performance liquid chromatography (HPLC) is one of the most important instrument used in pharmaceutical industry. Most of the pharmacopeial monographs methods is based on HPLC ..read more
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Basic Difference of HPLC and GC Technique
Veeprho Laboratories Pvt.Ltd
by Venkat Shinde
3y ago
High-performance liquid chromatography (HPLC) and gas chromatography (GC) is a multipurpose and very well accepted chromatographic technique utilized for the separation of complex mixtures. HPLC and GC ..read more
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Difference Between LC, LC-MS, LC-MS-MS, and HR-MS
Veeprho Laboratories Pvt.Ltd
by Venkat Shinde
3y ago
What is LC? Liquid chromatography (LC) is fast and effective separation technique for the constituent of a mixture and purification of compounds. It is based on ..read more
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Technical and Regulatory considerations for Pharmaceutical Product Lifecycle Management
Veeprho Laboratories Pvt.Ltd
by Venkat Shinde
3y ago
Introduction  Product Lifecycle Management(PLM) is the route of handling the entire lifecycle of a product from its beginning, through product machine design and manufacturing procedure, to ..read more
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Qualification of Pharmaceutical Working Standards
Veeprho Laboratories Pvt.Ltd
by Venkat Shinde
3y ago
The certified standard is very much important in pharmaceutical analysis. It ensures that the performed analysis is accurate and assure the safety of drug product. The ..read more
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Nitrosamine Impurities in Pharmaceuticals & Foods
Veeprho Laboratories Pvt.Ltd
by Venkat Shinde
3y ago
Overview Nitrosamines are general organic complexes and found often in foods, vegetables, rubber products, pharmaceutical products, and even in water in trace levels. Nitrites found in ..read more
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