Amit Kumar (AK)

Oncology formulations are complex and tailored to address the unique challenges posed by Cancer therapy which may include the need for targeted delivery, enhanced efficacy and reduced systematic toxicity. We at #actylis have range of excipients to be offered which are meant and suitable for oncology formulations. #biopharmaecuticals #injectables #oncology

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Importance of Ultrafiltration & Diafiltration in mAbs Manufacturing #ultrafiltration #diafiltration #mAbs #manufacturing #quality #safety #efficacy #bioprocessing #proteinpurification https://lnkd.in/gY2Xp5C9

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Continuation for the last post.... The answer to the first question is that there are no guidelines for the 3 batches concept, even FDA, and ISO have not specified the 3 batches concept. “FDA guidelines for industry on process validation general principles and practices” does not talk about the 3 batches concept and it also does not specify the number of batches. The number of batches for validation depends on the risk involved. The pharmaceutical industries have to decide the number of batches required for manufacturing. The main purpose for selecting the number of batches is to support the statistical data. For The product for which we have less data we will have to perform validation on more batches. Justification for 3 Batches. The traditional justification behind the selection of 3 batches is that during manufacturing of the 1st batch, quality may be built in the product accidentally. During manufacturing of 2nd batch quality may be regular. If the same quality is achieved in the 3rd batch it means that our results are consistent and are reproducible so it ensures validation or quality of the 3rd batch gives us assurance that our process is validated. If we get the desired quality standards in the first batch it may be an incident and if we get the same quality in the second batch it may be coincident and if we get the same quality in the third batch it is called consistent. Why not less than 3? For confirmation of reproducibility we should have sufficient numbers of batches to compare batch to batch variations. If we select 2 batches for validation then we cannot compare the data of two batches because comparison between two points always gives a linear line so to show a difference we need three points. So generally we take 3 or more than 3 batches for validation. Why not More than 3? As we know currently there are no guidelines available for selecting the minimum or maximum number of batches so we can also take 4 or 5 batches. As the number of batches is increased the cost of the process and time required is increased so all pharmaceutical companies usually select 3 batches for validation. Conclusion:- There are no guidelines for selecting 3 batches for validation, we only use 3 batches to show better statistical data for reproducibility. Even some companies are taking one or more engineering batches before commencing the process validation. --------END OF THE ARTICLE-------

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Dissolution test can be Performed for which of the following? a)Solid b)Liquid c)Gases d)All of the above Read answer in following https://lnkd.in/da8hkyNu

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Nitroso Rilpivirine Impurity - Ready Stocks #NItroso #Rilpivirine #API #apiimpurities #impurities #CRO #Pharmaceuticals #DrugDevelopment #QualityControl #AnalyticalChemistry  #ClinicalTrials #ChemicalAnalysis #ImpurityTesting #ContractResearchOrganization #PharmaIndustry #DrugManufacturing #DrugFormulation #Pharmacovigilance #DrugDiscovery #ChemicalSynthesis #ImpurityIdentification #ProcessValidation #QualityAssurance #DrugTesting #DrugRegulation #PharmaceuticalStandards #ImpurityCharacterization #DrugQuality #ChemicalPurity #CROServices #Isolation #Purification #characterization  

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Today I got that mail in my documents that is proof of successful completion of 70+ proposals of reduced testing and got CBE30 approval and Variation Type I B by my self so that organization goes monthly 7-8 crore rupees profit per month. We were congratulated by Plant Head Mr. Amar Pawar. Though it was entirely my efforts as project was suggested by me and entire work done only by me from zero to end, then also my efforts were hidded to give credit to useless teammates (Read their names in email ids written by Sachin saboo of RA). Let's Forget all useless fellows! The amazing thing was when I did this project I was zero in knowledge of pharmaceutics. In 2020 I resigned from USV PRIVATE LIMITED by giving commitment to owners that within coming 5 years I will start 5 multiple units that are equivalent to USV. I learnt entire pharmaceutics and advance drug delivery system with marketing, sales, business development, product development, synthesis, all kind of plant design with zero defects and least costing, made relation with FDA, European Union, Health Canada | Santé Canada, CDSCO FDA India MoHFW etc. I did this, Just to complete that commitment that I had taken in emotion. Because after learning these all I realise that these industrialists are wasting their time and efforts in business of most useless products of the world known as Allopath. In these 5 years I learnt how useless are Pharmacists and Allopathic doctors that they even can not able to cure simple fever or headache. Today, I am solving very crucial problems of entire pharmaceutics that is instability of drug products and making robust formulae that can survive and stable under all adverse conditions manufactured by cheapest raw material (within specifications) and can compete products manufactured by high cost (quality) raw materials. Also my main work I am doing on Drug Research that based on cure machanism and not on relief specially for children's (pediatrics). In this drug delivery system is unique that can absorb through mucosal lining of chicks, skin, skull, palm and sole, through light, moisture etc. No need of injection and devices (zero pain) for drug delivery, no need of ingestion (through stomach) no use of solvents, coating material and preservatives. With the same my project, "Entire Lab on single Instrument" makes all analytics on single instrument that will do Id test, description, Assay, impurity, toxicity, pH, BD, TD, MLT, Sterility etc entire analysis by using just 0.5 GM to 1.0 GM sample in 10 hrs. Very interesting thing is I am customising entire world's drug product applicable to cure all diseases in only 100 products that not needs prescription of any doctors even cure broken bones. As we know today orthopaedics have no cure system. They only giving medicines to do timepass. So we should have to welcome new era of medicines.

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Thixotropy is the property of some excipients which affects_______ a)Density b)Disintegration c)Viscosity d)Lubrication Read Answer in following https://lnkd.in/dFEpBqFR

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Why Single use equipment’s are revolutionizing in Biopharma Industries? 1. Reduce the Contamination. 2. Less turnover time for process. 3. Facility size shall be reduced. 4. Capital Investment will be reduced. 5. Facility can be utilized for multiple products. 6. Cleaning Validation not required. 7. Easy for regulatory approvals. #singleuseequipment #contamination #control #facilitydesign #cleaningvalidation #guideline #manufacturing #regulatory #approvals

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Post 5 70 Most asked Interview questions and answers for pharma jobs (Formulation Development & Quality Control) Q58. What is the Ultraviolet-Visible (UV) spectrophotometer application? Ultraviolet-Visible spectroscopy or Ultraviolet-Visible spectrophotometer (UV-Vis or UV/Vis) refers to absorption spectroscopy or reflectance spectroscopy in the ultraviolet-visible spectral region. Q59. What is stress testing? Stress testing of the drug substance can help identify the likely degradation products, establish degradation pathways, and validate the stability indicating power of the analytical procedures used. Q60. What is Viscosity? Viscosity is the measurement of a material's resistance to flow. Q61. What is Zeta Potential? Zeta Potential is defined as the potential difference between the dispersion medium and the stationary layer of fluid attached to the dispersed particle. Q62. What is Pyrometer? Pyrometer is a non-contacting device that intercepts and measures thermal radiation, a process known as pyrometry. Q63. What is Reference standard? Reference standard is a standardized substance used as a measurement base for similar substances. Q64. What is Thin layer chromatography (TLC)? Thin layer chromatography (TLC) is a widely employed laboratory technique used for faster and better separations. Q65. What is Predictable dissolution? Predictable dissolution is the in-vitro dissolution study that predicts the in-vivo dissolution (drug release) rate. Q66. What is Drug Master File (DMF)? Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. Q67. What are pharmaceutical impurities? Pharmaceutical impurities are any component of a drug substance that is not the chemical entity defined as the drug substance. Q68. What is meant by titration? Titration is a process of chemical analysis in which the quantity of some constituent of a sample is determined by adding to the measured sample an exactly known quantity of another substance with which the desired constituent reacts in a definite, known proportion. Q69. What parameters to be checked for method validation? Selectivity/Specificity, Precision, Accuracy, Linearity, Range, Stability, Limit of Detection (LOD), and Limit of Quantitation (LOQ) are the parameters to be checked for method validation. Q70. What is UPLC? Ultra-Performance Liquid Chromatography (UPLC) is an updated version of HPLC.

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SEZ units can understand how to get IRN And DRN in ICEGATE by using enclosed flow chart. # SEZ units #ICEGAte # customs #CBIC

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