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MFR For Ornidazole Tablets 500 mg

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 mg Brilliant …

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STABILITY STUDY PROTOCOL

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 + …

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MASTER MANUFACTURING FORMULA OF LISINOPRIL & HYDROCHLOROTHIAZIDE 10+12.5 MG TABLETS

MASTER MANUFACTURING FORMULA OF LISINOPRIL & HYDROCHLOROTHIAZIDE 10+12.5 MG TABLETS 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 dihydrate …

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OPERATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT

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 …

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SOP on the Transfer of Technology for Analytical Method

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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Pharma guidance Mobile App

Pharma guidance Mobile App   https://play.google.com/store/apps/details?id=com.smartwebarts.pg  

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Why disinfectant sterilization required in pharma injectable?

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 …

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SOP on Transfer of Technology for Manufacturing process

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 …

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INSTALLATION QUALIFICATION PROTOCOL FOR AIR HANDLING 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 …

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DESIGN QUALIFICATION FOR PURIFIED WATER STORAGE & DISTRIBUTION SYSTEM

TABLE OF CONTENTS 1.0       DESIGN QUALIFICATION PROTOCOL APPROVAL 2.0       INTRODUCTION 3.0       OBJECTIVE: 4.0       SCOPE 5.0       RESPONSIBILITY 6.0       BASIS OF DESIGN 7.0       SYSTEM DESCRIPTION 8.0     SCOPE OF SUPPLY AND TECHNICAL SPECIFICATIONS 9.0       PANEL INTERLOCKS AND OPERATIONAL LOGICS 10.0    CRITICAL SAFETY REQUIREMENTS 11.0    SAMPLING PLAN 12.0    SANITISATION CYCLE 14.0    LIST OF APPROVED …

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USFDA Critical Observation 2019 in Brief – In pharmaceutical Company

  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 …

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SOP on Fogging of Microbiology Testing Areas

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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Spoken English Guru Chart

                                                    Referance:          

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SOP on cleaning and operating procedure of bursting strength tester

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 …

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SOP on Operation of Effluent Treatment Plant

Objective: To lay down the procedure for operation of Effluent Treatment Plant. Scope: This SOP is applicable for engineering department for operation of effluent treatment plant at formulation plant. Responsibility: Technician/above –Engineering. Department is responsible for operation of ETP Plant. Accountability: Head- Engineering. Shall be accountable for implementation and compliance …

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Funny Video Tik Tok

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Comedy scenes from hindi movies

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Validation Observations Recording Format -I for steam steriliser and load Pattern

Recording Of Observations For Revalidation Identification Of The Executors   S. No. Name Designation & Department Sign & Date Training Details         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 …

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Handling of Microbiological Data Deviation in Microbiology Laboratory

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 …

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SOP on OOS in microbiology

Objective: To lay down the procedure for investigation of out of specification of test results in Microbiology Laboratory. Scope: This Scope is limited to out of specification results of microbial testing, sterility testing and environmental testing in microbiology section of Formulation plant. Responsibility: Head Microbiology Head Quality Control Accountability: Head-Q.A …

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