SOPNest – Your Home for Pharma SOPs

STANDARD OPERATING PROCEDURE Karl Fischer Water Determination & Instrument Operation 1. Objective To determine water content by Karl Fischer titration using volumetric and coulometric methods, and to perform instrument operation and re-standardization following USP <921>, IP, BP, EP, and manufacturer’s guidelines. 2. Scope Applicable to substances analyzed for water content using KF titrators in the QC laboratory. Covers both volumetric and coulometric titration, instrument operation, calibration, and sample analysis. 3. References USP <921> Water Determination Indian Pharmacopoeia – Water Determination British Pharmacopoeia – Water Determination European Pharmacopoeia – Water Determination Manufacturer User Manual (Metrohm / Matic / Labind India) 4. Apparatus & Reagents Karl Fischer titrator (volumetric or coulometric) Automatic buret(s) or coulometric cell Platinum electrodes and magnetic stirrer Tightly sealed titra...

OPERATION AND CLEANING OF REFRIGERATOR IN QC LABORATORY 1.0 PURPOSE To establish standardized procedure for operation, monitoring, cleaning and maintenance of refrigerator used in Quality Control Laboratory for storage of reference standards, working standards, reagents and microbial cultures at temperature 2-8°C. 2.0 SCOPE This SOP is applicable to Refrigerator (Make: ________ Model: ________ Sr. No: ________) located in Quality Control Laboratory used for storage of temperature sensitive materials requiring 2-8°C storage condition. 3.0 RESPONSIBILITY Designation Responsibility QC Analyst Daily monitoring, operation & cleaning QC Executive Review of records & monitoring data Head QC Compliance & training ...

STANDARD OPERATING PROCEDURE Operation, Calibration and Performance Verification of Shimadzu TOC-L Total Organic Carbon Analyzer 1.0 Purpose To describe the procedure for operation, calibration, system suitability testing, performance verification, and shutdown of the Shimadzu TOC-L Total Organic Carbon (TOC) analyzer to ensure accurate, precise, and reproducible TOC results in accordance with applicable pharmacopoeial and regulatory requirements. 2.0 Scope This SOP applies to the analysis of Purified Water (PW), Water for Injection (WFI), and cleaning validation samples using the Shimadzu TOC-L series in the Quality Control Laboratory. 3.0 Responsibility Designation Responsibility QC Analyst Operation, calibration, SST, sample analysis, and documentation QC Supervisor Review and verification of results QA Overall GMP compliance and SOP control Engineering Instrument maintenance and servicing 4.0 Accountability The Qua...

STANDARD OPERATING PROCEDURE (SOP) Operation & Calibration of Melting Point Apparatus 1. Objective To establish a standardized and regulatory-compliant procedure for the operation, calibration, and performance verification of the melting point apparatus in order to ensure accurate, reliable, and reproducible results. 2. Scope This SOP applies to all analytical and quality control laboratories involved in melting point determination of pharmaceutical raw materials, intermediates, and finished products. 3. Regulatory & Reference Standards USP <741> – Melting Range or Temperature Ph. Eur. 2.2.14 – Melting Point Indian Pharmacopoeia – Melting Point ICH Q2(R1) – Validation of Analytical Procedures WHO GMP Guidelines ISO/IEC 17025 Instrument Manufacturer’s Manual ...

STANDARD OPERATING PROCEDURE (SOP) Handling of Incidents, Root Cause Analysis (RCA), and CAPA SOP No. QA/SOP/___ Effective Date ___ Revision No. 00 Department Quality Assurance 1. Purpose To define a comprehensive, structured, and regulatory-compliant procedure for identification, reporting, numbering, investigation, root cause analysis (RCA), corrective and preventive action (CAPA), and closure of incidents to ensure product quality, data integrity, and patient safety. 2. Scope This SOP applies to all GMP-related incidents, deviations, abnormalities, data integrity events, and failures occurring in Quality Control, Manufacturing, Engineering, Warehouse, and support departments. 3. Regulatory References FDA 21 CFR 211.100 and 211.192 WHO GMP – Quality Assurance EU GMP Part I – Chapters 1 and 8 ICH Q10 – Pharmaceutical Quality System 4. Definitions Incident: Any unplanned event or deviation from approved procedu...

STANDARD OPERATING PROCEDURE (SOP) Glassware Management and Cleaning in Quality Control Laboratory SOP No. QC/SOP/___ Effective Date ___ Revision No. 00 Department Quality Control 1. Purpose To establish a controlled, validated, and step-by-step procedure for receipt, use, cleaning, detergent selection, inspection, and storage of laboratory glassware to prevent contamination, cross-contamination, and analytical errors in compliance with GMP, WHO, FDA, and EU-GMP requirements. 2. Scope This SOP applies to all reusable laboratory glassware used for analytical testing including volumetric flasks, pipettes, burettes, beakers, conical flasks, test tubes, chromatographic glassware, and other analytical glass items. 3. Regulatory References WHO GMP – Laboratory Control FDA 21 CFR Part 211.67 – Equipment Cleaning and Maintenance EU GMP Part I – Chapter 3 ICH Q7 – Cleaning and Maintenance 4. Definitions Laboratory Dete...

STANDARD OPERATING PROCEDURE (SOP) Preventive Maintenance of Laboratory Instruments and Equipment SOP No. ENG/QC/SOP/___ Effective Date ___ Revision No. 00 Department Engineering / Quality Control 1. Purpose To establish a controlled, systematic, and documented procedure for preventive maintenance of laboratory instruments and equipment to ensure reliable performance, minimize breakdowns, maintain calibration status, and comply with GMP, WHO, FDA, and EU-GMP requirements. 2. Scope This SOP applies to all GMP-critical and non-critical laboratory instruments and equipment used in Quality Control, Quality Assurance, and related support areas. 3. Definitions Preventive Maintenance (PM): Planned and periodic maintenance activities performed to prevent equipment failure and ensure consistent performance. GMP-Critical Equipment: Equipment having direct impact on product quality or data integrity. 4. Responsibilities E...

STANDARD OPERATING PROCEDURE (SOP) Annual Maintenance Contract (AMC) and Comprehensive Maintenance Contract (CMC) SOP No. ENG/QC/SOP/___ Effective Date ___ Revision No. 00 Department Engineering / Quality Control 1. Purpose To establish a controlled and systematic procedure for planning, execution, monitoring, and review of Annual Maintenance Contracts (AMC) and Comprehensive Maintenance Contracts (CMC) for laboratory instruments and equipment to ensure consistent performance, regulatory compliance, and minimization of breakdowns. 2. Scope This SOP applies to all GMP-critical and non-critical laboratory instruments and equipment covered under AMC or CMC agreements in Quality Control, Quality Assurance, Engineering, and related departments. 3. Definitions AMC (Annual Maintenance Contract): A contract covering preventive maintenance and limited corrective services excluding major spare parts. CMC (Comprehensive Mainten...

STANDARD OPERATING PROCEDURE (SOP) Analyst Qualification in Quality Control Laboratories SOP No. QC/SOP/___ Effective Date ___ Revision No. 00 Department Quality Control 1. Purpose To define a comprehensive and step-by-step procedure for qualification, authorization, and requalification of analysts working in the Quality Control laboratory, ensuring accuracy, reproducibility, data integrity, and compliance with GMP, WHO, FDA, EU-GMP, and ICH Q2 requirements. 2. Scope This SOP applies to all analysts performing chemical and instrumental analysis in the Quality Control laboratory, including new employees, experienced analysts, reassigned staff, and contract personnel. 3. Responsibilities QC Head: Final approval of analyst qualification and authorization. QC Manager / Supervisor: Planning, execution, assessment, and recommendation. Analyst: Compliance with SOPs, training, and qualification activities. Quality Assuranc...

SOP FOR OPERATION AND CALIBRATION OF UV CABINET GMP Compliant | QC Laboratory | Pharmaceutical Applications 1. Purpose To provide a detailed, step-by-step procedure for the operation, calibration, and maintenance of the UV Cabinet to ensure proper UV light exposure, accurate wavelength, and reproducible results for analytical and photostability studies. 2. Scope This SOP applies to all UV Cabinets used for photostability testing, degradation studies, and any UV exposure tests performed in the QC or R&D laboratory. 3. Responsibilities Analyst: Operate the UV Cabinet, perform calibration, and record results. QC Supervisor: Review calibration records and approve operations. QA: Ensure compliance with GMP and review deviations. 4. Safety Precautions Wear PPE including lab coat, UV-protective goggles, and gloves. Avoid direct exposure to UV light to prevent skin and eye damage. Ensure proper ventilation inside the lab. Handle UV lamps carefu...

OPERATION AND CALIBRATION OF TABLET HARDNESS TESTER GMP Compliant | Pharmacopoeial Methods | QA/QC Laboratory 1. Purpose To define the procedure for the operation, calibration, and maintenance of the tablet hardness tester to ensure accurate, reliable, and reproducible measurement of tablet mechanical strength in accordance with pharmacopeial and regulatory requirements. 2. Scope This SOP applies to all tablet hardness testers used for routine quality control, in-process testing, and stability studies of tablets in the pharmaceutical laboratory. 3. Responsibilities Analyst: Perform hardness testing, calibration, and record results accurately. QC Supervisor: Verify calibration and test data, approve results. QA: Ensure compliance, review deviations, approve final records. 4. Safety Precautions Wear PPE (lab coat, gloves, goggles). Handle tablets carefully to avoid damage and spillage. Follow electrical safety while operating the instrument. ...

STANDARD OPERATING PROCEDURE Operation, Calibration, and Verification of Dissolution Test Apparatus 1.0 Purpose To establish a harmonized and standardized procedure for operation, physical (mechanical) calibration, chemical calibration (Performance Verification Test), and verification of the dissolution test apparatus to ensure accurate, reproducible, and pharmacopoeial-compliant dissolution testing as per IP, BP, USP <711>, and EP 2.9.3. 2.0 Scope This SOP is applicable to all dissolution test apparatus (USP Apparatus I – Basket and USP Apparatus II – Paddle) used in the Quality Control Laboratory for testing tablets and capsules. 3.0 Responsibility Designation Responsibility QC Analyst Operation, calibration, PVT execution, testing, and documentation QC Supervisor Review of calibration, PVT, and test results QC Manager Approval and compliance with IP/BP/USP/EP Engineering Preventive maintenance and servicing 4.0 References Indian ...

STANDARD OPERATING PROCEDURE Operation, Calibration, and Verification of Disintegration Test Apparatus 1.0 Purpose To define a standardized procedure for operation, calibration, and verification of the disintegration test apparatus to ensure reproducible and pharmacopoeial-compliant disintegration times of tablets and capsules as per IP, BP, USP <701>, and EP 2.9.1. 2.0 Scope Applicable to all disintegration test apparatus used in the Quality Control Laboratory for solid oral dosage forms. 3.0 Responsibility Designation Responsibility QC Analyst Perform operation, sample preparation, calibration, verification, and record data QC Supervisor Review and verification of results and calibration records QC Manager Approval and overall compliance with pharmacopoeia Engineering Preventive maintenance, servicing, and troubleshooting 4.0 References Indian Pharmacopoeia (IP) British Pharmacopoeia (BP) USP <701> Disintegration Europea...

STANDARD OPERATING PROCEDURE Operation and Calibration of Conductivity Meter 1.0 Purpose To describe the standardized procedure for operation, calibration, and verification of the conductivity meter using USP conductivity buffer solutions to ensure accurate measurement of conductivity in pharmaceutical samples in accordance with USP <645>. 2.0 Scope This SOP applies to all conductivity meters used in the Quality Control Laboratory for analysis of aqueous solutions, raw materials, and finished pharmaceutical products. 3.0 Responsibility Designation Responsibility QC Analyst Operation, calibration, verification, and documentation QC Supervisor Review and verification of results QC Manager Overall compliance and approval Engineering Maintenance and servicing 4.0 Accountability The QC Manager is accountable for implementation and compliance with this SOP. 5.0 References USP <645> Conductivity Indian Pharmacopoeia British ...

STANDARD OPERATING PROCEDURE Operation and Calibration of pH Meter 1.0 Purpose To describe the standardized procedure for operation, calibration, and verification of the pH meter using USP buffer solutions to ensure accurate pH measurement in accordance with USP <791>, IP, BP, and EP. 2.0 Scope This SOP applies to all pH meters used in the Quality Control Laboratory for analysis of raw materials, intermediates, and finished pharmaceutical products. 3.0 Responsibility Designation Responsibility QC Analyst Operation, calibration, verification, slope check, and documentation QC Supervisor Review and verification of results QC Manager Overall compliance and approval Engineering Maintenance and servicing 4.0 Accountability The QC Manager is accountable for implementation and compliance with this SOP. 5.0 References USP <791> pH Indian Pharmacopoeia British Pharmacopoeia European Pharmacopoeia 2.2.3 pH Meter Manufacture...