Electronic Signatures

Electronic Signatures Controls for identification codes/password Persons who use electronic signatures based upon the use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include: (a) Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination … Read more

IQ of AUTOMATIC AIRJET BOTTLE AIR AND VACUUM CLEANING MACHINE

INSTALLATION QUALIFICATION of AUTOMATIC AIRJET BOTTLE AIR AND VACUUM CLEANING MACHINE Contents Pre Execution Approval Objective Equipment Description Participants Log Installation Qualification Checklist Sub-Component CheckList Component Location List MOC Verification List Test / Inspection Reports Utility Verification List Attachment Log Summary, Conclusion, and Recommendation Abbreviations Post Execution Approval OBJECTIVE: Installation Qualification protocol for Automatic Air … Read more

Cefazolin Sodium for Injection 1000 mg

Cefazolin Sodium for Injection 1000mg GENERAL INSTRUCTIONS: Good manufacturing practices should be followed during the entire process of manufacturing including sampling and dispensing. All the containers and equipment used for manufacturing shall be properly cleaned as per the relevant SOP of the current version. All the equipment and containers should have a proper status label … Read more

CARBOPLATIN INJECTION 150MG/15ML

CARBOPLATIN INJECTION 150MG/15ML CARBOPLATIN  is a chemotherapy drug. It targets fast-dividing cells, like cancer cells, and causes these cells to die. This medicine is used to treat ovarian cancer and many other cancers. Carboplatin  Injection is an anticancer medicine that is used in the treatment of ovarian cancer (cancer of the ovary, part of the female … Read more

AMOXYCILLIN CLAVULANATE FOR INJECTION

AMOXYCILLIN CLAVULANATE  FOR INJECTION PRODUCT INTRODUCTION AMOXYCILLIN- CLAVULANATE FOR INJECTION  is a penicillin-type of antibiotic that helps your body fight infections caused by bacteria. It is used to treat infections of the lungs (e.g., pneumonia), ear, nasal sinus, urinary tract, skin, and soft tissue. It will not work for viral infections such as the common … Read more

INSTALLATION QUALIFICATIONS OF DISPENSING BOOTH

INSTALLATION QUALIFICATIONS OF DISPENSING BOOTH TABLE OF CONTENT Purpose Scope Responsibilities Procedure Installation Qualification tests Documents & Drawings Verification Verification of Technical Specification for In-House & sub-components / Bought out items Utilities Verification Material of Construction Verification Critical Instrument Calibration Verification Installation Qualification Tests Status Data Analysis, Summary of IQ & Recommendations Amendment Record Conclusion … Read more

SOP for Operating Procedure for Gelatin Storage Vessel

SOP for Operating Procedure for Gelatin Storage Vessel Check the ‘CLEANED’ status label duly filled and signed on the Gelatin Storage Vessel, then unwrap the cling film. Ensure the cleanliness of the Gelatin Storage Vessel. Affix ‘BATCH IN-PROCESS’ status label on Gelatin Storage Vessel duly filled and signed. Record all observations in line clearance record. … Read more

SOP on Intermediate and finished product Analysis and Approval

SOP on Intermediate and finished product  Analysis and Approval To lay down the procedure for testing Intermediate samples and finished product. Procedure: Quality Assurance personnel shall collect the sample of finished and intermediate products and affix the “sample for analysis” label along with a Sample Intimation Slip filled with all details. The finished product shall … Read more

BETAMETHASONE AND NEOMYCIN EYE/EAR DROPS

BETAMETHASONE AND NEOMYCIN EYE/EAR DROPS Betamethasone & Neomycin Sulphate Eye/Ear Drops are a combination drug of antibiotic and steroid medicine that is used when there is a risk of bacterial infection in or around the eye. USES OF BETAMETHASONE & NEOMYCIN EYE / EAR DROPS Betamethasone & Neomycin Sulphate Eye / Ear Drops are used … Read more