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 mg Brilliant Blue, Quinoline Yellow…
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 % RH 6 months …
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 dihydrate equivalent to Lisinopril………10 mg…
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AIR HANDLING UNIT & AIR DISTRIBUTION SYSTEM The AHU is designed to circulate the air in the area after passing it over cooling coils to maintain the required environmental conditions and pass it through the filters to maintain the desired cleanliness level. The air intake and out-take of the system is designed to support a…
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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 training for carrying out the…
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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 inanimate objects and reduces the…
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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 (F R&D ) are :…
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AIR HANDLING UNIT & AIR DISTRIBUTION SYSTEM The air handling unit (AHU-GF-02) is a recirculation system, in double-skin modular construction. AHU will have an extruded aluminum frame with a sandwiched panel of G.I. sheet duly pre-coated from the outside & 43 mm thick PUF filled in between. Fresh air enters through a 10µ fresh air…
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FOR PURIFIED WATER STORAGE & DISTRIBUTION SYSTEM The Purified Water from the upstream generation System is stored in a Vertical Jacketed Storage tank From the storage tank the water is then supplied to various user points in the Production area. The Purified Water storage tank is controlled with the help of a capacitance-type level transmitter,…
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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 a failure to thoroughly review…
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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 in a week at the…
Referance:
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 the cleaning & analysis as…
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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 sustainable management of industrial wastewater….
Validation Observations for steam sterilizer and load Pattern Recording Of Observations For Revalidation Steam Quality Tests 1. 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 volume of water collected in the measuring…
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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 Limit test, Liquid borne particulate…
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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 the dependability of microbiological data,…
Performance Qualification Report for Steam Sterilizer Performance Qualification is verified that all test cases required by the protocol are completed, reconciled, and included in the qualification summary report. Signatures in the block below indicate that all items in this Qualification Report have been reviewed and found to be acceptable. SUMMARY REPORT Data generated during qualification…
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Load Pattern & Justification for Steam Sterilizer APPROVAL SIGNATURES The signing of this approval page of the load pattern indicates agreement with the qualification approach described in the PQ protocol. If any modification in the load pattern becomes necessary, a revision through change control shall be prepared, checked, and approved. Wherever applicable revalidation of the…
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