Citizen
Full Time
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PG :- - Not Required
No of position :- ( 1 )
Post :- 1st Sep 2022
R&D Executive/Sr. Executive Product Development For Pharma Industry. (Formulation)
Job Description
R&D Executive/Sr. Executive Product Development For Pharma Industry. (Formulation)
selection of products for method validation, Clearly read the method and arrange the standard for method validation. I f the standard not with us we have to order the primary standard, if we have API material we have to do working qualification for the API with primary standard. Next arrange the column and required chemicals. Start the preparation of protocol for method validation as per SOP. Then we have to get approval for the protocol. After approval start the Analysis for method validation.first we have to do pre-validation. if there is no issue we have to go for validation parameters.
1.System suitability
2.Specificity
3.Method precision
4.Linearity
5.Recovery and range
6. Ruggedness
7.Filter paper variability
8.Solution stability
After completing the analytical method validation analysis part we have to start the preparation of report. we have to take review and approval from QA. After approval send the document to QA.
*For Related Substances AMV Limit of Detection and Limit of Quantification- generation and find the LOD and LOQ for Active ingredients and impurities. we have to do Recovery of impurities also for Related Substances Method validation. when we prepare mobile phase for HPLC, must and should filter the mobilephase and degass it.
check the all equipments are calibrated or not. Method Development: we have to know the physical and chemical properties of drug. order the API material for method development. select the mobilephase and mobile phase pH. Based on pH select the column for stationary phase. select the diluent for drug based on solubility.
Find the wavelength. Chech the response of peak at the fixed wavelength. Find the assay of given drug. selection of media for percentage drug Dissolution. select the rpm and temperature of Dissolution media based on sink condition. select the dissolution apparatus. find the impurities with partial validation.Mainely linearity and recovery.
Drug to drug compatibility-
1.API+API
2.API+Placebo
3.Placebo
4.API Preparation of protocol for drug drug compatibility and take review approval from QA.
start the Analysis and prepare the report check the compatibility percentage. Saturation solubility: solubility: check the media for drug solubility. find the pH of media for drug solubility. Saturation study: for this take minimum 5-8 media and continusly stir with stable RPM and collect the sample for different time intervals minimum each 2 hours. check the Percentage assay for each time intervals and find the saturation level.
Forced Degradation studies: physical and chemical Degradation studies Physical:
1. Thermal treated
2.Humidity treated
3.Pholytic Chemical
1.Acid treated
2.Base treated
3.Peroxide treated
Finally we have to compare the treated samples with untreated sample. Method transfer: preparation of method transfer protocol and get the approval. Start the Analysis which method was validated that method we have to transfer. as per protocol start the Analysis. we have to send our protocol to other company. we have to start the Analysis at the same time simultaneously that company also start the Analysis. Finally we have to compare the method precision results for assay and dissolution. For Related Substances calculate the Percentage impurities in method precision and recovery.
Cleaning Validation: main role recovery recovery methods Swab method. Find the percentage recovery of active ingredient by swab method. Calibration of equipments: monthly calibration of analytical balance check the precision and accuracy and esentricity of balance. every 6 months calibration for HPLC system precision, linearity of injector and Detector linearity, drift and noise, flow rate accuracy and injector accuracy. Melting point calibration: vanillin caffeine sulfanilamide acetanilide used for calibration of melting point apparatus due to stable at melting range of these comments. calibration of KF apparatus calibrate the flow rate precision 1ml,5ml and 10mL.
Roles And Responsibilities:
Instruments Handled:
Wet Analysis:
Strengths: