Quality Control

SYSTEM MAINTENANCE PROCEDURE FOR STABILITY CHAMBER GENERAL MAINTENANCE ONLY TRAINED AND SKILLED PERSONS SHOULD MAINTAIN THE MACHINE. Follow work permit procedure before any maintenance work. Thermolab will not be responsible if the same is ignored. Check whether the stability chamber is clean from inside and outside after use. Check the …

HANDLING OF AUDIT TRAIL PURPOSE: This SOP describes the procedure for Handling of system audit trail/ Batch audit trail report which is generated by the manufacturing, packing, warehouse and utility equipment. SCOPE: This SOP is applicable to all manufacturing, packing, warehouse and utility equipment. RESPONSIBILITY: User Department: To prepare procedure …

COMPUTERIZED SYSTEM LIFE CYCLE PURPOSE: The purpose of this procedure is to define the system life cycle methodology that shall be used while implementing GxP computerized system to ensure that system remains in state of validation throughout the system life cycle. SCOPE: This SOP is applicable for all GxP computerized …

SHELF LIFE EXTENSION OF EXISTING COMMERCIALIZED PRODUCTS PURPOSE: To define a procedure for shelf life extension of existing commercialized products. SCOPE: This procedure shall be applicable for shelf life extension of existing commercialized products  which comprises volumes of Domestic market. RESPONSIBILITY: Site Quality Assurance To provide stability study data for …

HANDLING OF PHARMACOPOEIAL CHANGES PURPOSE: To lay down a procedure for the handling of Pharmacopoeia! changes. SCOPE: This procedure shall be applicable for Assessment and Implementation of Pharmacopoeia changes in API, Excipient and Drug products those are handled when appearing in the official Pharmacopoeia like IP, BP,USP and Ph. Eur. …

QUALIFICATION OF CONTRACT TESTING LABORATORY The purpose of this SOP is to describe the procedure for selection, approval, renewal of contract testing laboratory for testing / calibrations. SCOPE OF CONTRACT TESTING LABORATORY: This procedure is applicable for testing done at contract testing laboratory for raw material, intermediate, packaging material, finished …

GLP-GOOD LABORATORY PRACTICES AND REQUIREMENTS OF PREMISES AND EQUIPMENTS General Requirements OF GLP :- The laboratory or the organization it belongs to must have legal authorization to operate and be held accountable under the law. The management is responsible for ensuring that the laboratory conducts its testing, calibration, validation, and other technical …

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 …

Quality Control Quiz 1 [ays_quiz id=’5′]

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 …

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 …

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 …

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 …

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 …

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 …

GMP Inspection HPLC Checklist 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 delivering solvent at a stable flow rate …

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 …

HPLC Chromatography High-Performance Liquid Chromatography (HPLC) has revolutionized the field of analytical chemistry, offering a powerful and versatile tool for separating, identifying, and quantifying compounds in complex mixtures.  High-Performance Liquid Chromatography has become an indispensable tool in various scientific disciplines, contributing significantly to advancements in research, quality control, and diagnostics. …

Reference-Standard and Working Standards The US Food and Drug Administration defines a reference-standard material as a “highly purified compound that is well characterized” (1). The US Pharmacopeia (USP) defines reference-standard materials as “highly characterized specimens of drug substances, excipients, reportable impurities, degradation products, compendial reagents, and performance calibrators” (2). Scientists …

HPLC  HPLC (High-Performance Liquid Chromatography) is a powerful analytical technique used for separating, identifying, and quantifying components in a mixture. It operates on the principles of liquid chromatography, with a liquid mobile phase carrying the sample through a stationary phase. The distinguishing feature of HPLC is the application of high …