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Pharmaceutical Guidanace

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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