Preparation, Approval and Control of Specifications and Standard Test Procedures Objective To lay down a procedure for the preparation, approval and control of Specifications and Standard Test Procedures for raw materials, packaging materials, in-process materials and finished products. Scope This Standard Operating Procedure is applicable for the preparation and implementation …
Read More »Quality Control Quiz 1
Quality Control Quiz 1
Read More »Quality Control -Questions and answers
Quality Control Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released …
Read More »Checklist for Do’s and Don’ts for Dissolution Analysis
Checklist for Do’s and Don’ts for Dissolution Analysis Checklist for Do’s Always check the availability of chemicals and required glassware for the analysis. Before loading dissolution check the Calibration status of the instrument. Always check the water level of the dissolution bath (without a bowl). Check the clarity of the water …
Read More »Checklist for Do’s and Don’ts for Using Glassware for Analysis
Checklist for Do’s and Don’ts for Using Glassware for Analysis Checklist for Do’s Use Class A Glassware for analysis Use transparent glassware for analysis Before using glassware for analysis check for cracks or breakage. Use exact capacity glassware by checking the marking of capacity e.g. ‘20’ flask not to be used …
Read More »Checklist for Do’s and Don’ts for Sample preparation of temperature / light-sensitive material and product
Checklist for Do’s and Don’ts for Sample preparation of temperature / light-sensitive material and product Checklist for Do’s In the case of temperature-sensitive / light-sensitive material collect samples from the respective storage area & allowed them to attain room temperature before using i.e weighing, pipetting, etc. During analysis close the sample …
Read More »DO’s & DON’Ts For Column care to avoid/Minimize incidences
DO’s & DON’Ts For Column care to avoid/Minimize incidences 1.0 New HPLC Columns(Except Silica Columns for Normal Phase) DO’s Before using the new column wash the column with water followed by an appropriate solvent mixture. For Silica Column for washing use solvent as Given in the Column Certificate. DON’Ts Don’t …
Read More »Checklist for Precautions during Sample Dilution /preparations in Wet Labs
Checklist for Precautions during Sample Dilution /preparations in Wet Labs Checklist for Do’s Use a bulb pipette for further dilution. During pipetting Wipe off the tip with clean tissue paper. Adjust the meniscus to eye level by discarding the solution to waste. Transfer the amount to the volumetric flask. Touch the …
Read More »GMP Inspection Checklist & Most frequently asked questions about HPLC
GMP Inspection Checklist & Most frequently asked questions about HPLC HPLC is an abbreviation for High-Performance Liquid Chromatography. “Chromatography” is a technique for separation, “chromatogram” is the result of chromatography, and “chromatograph” is the instrument used to conduct chromatography. HPLC dedicated to molecular separation called columns and high-performance pumps for …
Read More »Water Analysis as per IP/BP/USP
Water Analysis as per IP/BP/USP Procedure for chemical testing and microbiological testing of Raw/Tap water, RO water, and purified water samples. Procedure for Water Analysis (Chemical & Microbiological) Carry out the determination under conditions designed to avoid extrinsic microbial contamination of the water sample for the analysis. The precautions taken …
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