Tag Archives: Reggio Calabria

Compression Machine FAT (Factory Acceptance Test) Compression Machine FAT – The purpose is to identify the quality acceptance tests performed at the suppliers’ facilities. Ensuring the compression runs well at startup is an important role of the equipment supplier. Proper design and fabrication are critical, but equally important is a …

SOP For Performance Qualification for Tablet Compression Machine TABLE OF CONTENTS 1.0 Approval 2.0 Objective 3.0 Responsibility 4.0 System Description 4.1 Equipment Identification 4.2 Description of Operation 4.3 Standard Operating Procedure Established During Operation Qualification 5.0 Validation Plan and Methodology 6.0 Performance Qualification Procedure 6.1 Effect of Machine Speed 6.2 …

SOP For MFR For Ornidazole Tablets 500 mg Label Сlaim Manufacturing Formula List of Equipment Manufacturing Instructions Manufacturing Process Flow Chart Manufacturing Process Details Packaging Finished Product Specifications Procedural Changes   Label Сlaim  Product Ornidazole Tablets 500 mg Strength 500 mg Label сlaim Each Film uncoated tablet contains: Ornidazole …………500 …

STABILITY STUDY PROTOCOL THIS PROTOCOL IS: Lisinopril and Hydrochlorothiazide tablets 10+12.5 mg CONTENTS: Each uncoated tablet contains: Lisinopril dihydrate equivalent to Lisinopril 10mg Hydrochlorothiazide                                           12.5mg SHELF LIFE: 24 months DOSAGE FORM: Tablet MANUFACTURED AT: TYPE OF STABILITY STUDIES: Accelerated stability studies 40 + 20C / 75 + 5 …

MASTER MANUFACTURING FORMULA OF LISINOPRIL & HYDROCHLOROTHIAZIDE 10+12.5 MG TABLETS Contains Label Сlaim Manufacturing Formula List of Equipment Manufacturing Instructions Manufacturing Process Flow Chart Manufacturing Process Details Packaging Finished Product Specifications Procedural Changes   Label Сlaim  Product Lisinopril & Hydrochlorothiazide Tablets Strength 10+12.5 mg Label сlaim Each tablet contains: Lisinopril …

OPERATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT & AIR DISTRIBUTION SYSTEM TABLE OF CONTENTS Pre-Approval Overview Purpose Requalification System Distribution System Description Operational Qualification Procedure Pre Requisite for OQ Test Test Equipments Qualification of Execution Team Inspection Checklist Operational Qualification Instrument Calibration Key Functionality Operational Checks SOP verification Deficiency, if any …

Objective: To lay down the procedure for Transfer of Technology for Analytical Methods. Scope: This procedure is applicable for Transfer of technology for Analytical Methods from ARD to Formulation Unit. Responsibility: Responsibility of Sending Unit (ARD ) are : Preparation of Technology transfer Protocol for Analytical Method transfer. Execution of …

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Disinfection Disinfection is a process that is designed to kill actively growing and vegetative microbial microorganisms to a certain level, and it does not, unless the disinfectant is classified as a sterilant, apply to bacterial endospores. Disinfection a process that eliminates many or all pathogenic microorganisms, except bacterial spores, on …

SOP on Transfer of Technology for Manufacturing process Objective: To lay down the procedure for Transfer of Technology for Manufacturing Process. Scope: This procedure is applicable for Transfer of technology (i.e. for Manufacturing process) from sending unit (F R&D) to receiving site (Manufacturing facility ) Responsibility: Responsibility of Sending Unit …

INSTALLATION   QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT & AIR DISTRIBUTION SYSTEM TABLE OF CONTENTS Sr. No Description Page No. 1 Objective 2 System / Equipment Description 3 Responsibility 4 Execution Team 5 Installation Verification 6 Installation Check 7 Documentation Requirement 8 Deviation Report 9 Installation Qualification Summary & Conclusion 10 Abbreviations …

DESIGN QUALIFICATION FOR PURIFIED WATER STORAGE & DISTRIBUTION SYSTEM TABLE OF CONTENTS DESIGN QUALIFICATION PROTOCOL APPROVAL INTRODUCTION OBJECTIVE: SCOPE RESPONSIBILITY BASIS OF DESIGN SYSTEM DESCRIPTION SCOPE OF SUPPLY AND TECHNICAL SPECIFICATIONS PANEL INTERLOCKS AND OPERATIONAL LOGICS CRITICAL SAFETY REQUIREMENTS SAMPLING PLAN SANITISATION CYCLE LIST OF APPROVED MAKES DESIGN QUALIFICATION APPROVAL …

USFDA WARNING LATTER 2019 – DRUGS   Reference Number Short Description Critical Observation and discripancies 21 CFR 211.22(d) Procedures not  in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. 21 CFR 211.192 Investigations of discrepancies, failures There is …

Objective: To lay down the procedure for Fogging of Microbiology Testing Areas Scope: This SOP is applicable for Fogging of Microbiology Testing Areas in Microbiology Laboratory. Responsibility: Chemist or above of Microbiology Laboratory: Head – Microbiology section. Accountability: Head – Quality Control. Procedure: Operation Perform the Fogging of Microbiology once …

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Objective: To lay down the cleaning & operating procedure of bursting strength tester. Scope: This SOP is applicable for the cleaning & operating procedure of bursting strength tester in quality control laboratory. Responsibilities: Chemist or above of QC laboratory in Packaging material Quality Control section is responsible for carrying out …

Effluent Treatment Plant (ETP) Effluent Treatment Plants (ETP) play a vital role in this endeavor, serving as essential systems for the treatment and purification of industrial wastewater. This article explores the importance, operation, and environmental implications associated with Effluent Treatment Plants. Effluent Treatment Plants are crucial for the responsible and …

Validation Observations Recording Format -I for steam sterilizer and load Pattern Recording Of Observations For Revalidation Steam Quality Tests Steam Non-Condensable Gas Test When the temperature of the water in the container reaches 70-75°C close the needle valve. Note the volume of gas collected in the burette (Vb) and the …

Objective: To lay down the procedure for Handling of Microbiological Data Deviation in Microbiology Laboratory. Scope: This procedure is applicable to environmental monitoring excursions (namely Passive air sampling, Active air sampling, Surface sampling, Personnel monitoring, and Compressed gas monitoring)obtained during the Environmental monitoring, Sterility testing, Bacterial Endotoxin Test, Bioburden, Microbial …

OOS in Microbiology Out-of-specification (OOS) occurrences pertain to situations where microbiological test outcomes deviate from predetermined acceptance criteria or specifications. These occurrences can arise due to a variety of factors, spanning from technical complications to procedural mistakes. The identification and resolution of OOS events play a crucial role in upholding …