PACKING INSERT: QUETIAPINE FUMARATE TABLETS Name and Strength of Active Substance(s) 1.Quetiapine fumarate ….mg equivalent to quetiapine 25mg 2.Quetiapine fumarate ….mg equivalent to equivalent to quetiapine 300mg Pharmacodynamics Mechanism of action…
Packing leaflet: Diclofenac Potassium, Paracetamol, and Chlorzoxazone Tablets Package leaflet: Information for the patient Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Keep this You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine…
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Package leaflet: Information for the user Pantoprazole 40 mg gastro-resistant tablets Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep this You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been…
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Caffeine, Paracetamol, Phenylephrine Hydrochloride and Cetirizine Tablets Information for the user Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription, however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read…
CLEANING CHECKLIST BLISTER PACKING MACHINE TYPE –A Check that all the remnants of previous product i.e. PVC / Alu. Foil and Rubber stereo etc .are removed from Machine and its area. Check that all contact parts are cleaned with sufficient quantity of potable water up to 10 minutes. Finally rinsed with sufficient quantity of purified water…
Azithromycin 250 mg Tablets IP TABLE OF CONTENTS S.NO. TITLE Page No. 1.0 PRODUCT DETAILS 2.0 MANUFACTURING FORMULA 3.0 LIST OF EQUIPMENT 4.0 GENERAL PRECAUTIONS 5.0 MANUFACTURING INSTRUCTIONS 6.0 MANUFACTURING PROCESS DETAILS 6.1 GRANULATION 6.2 COMPRESSION 6.3 COATING 1.0 PRODUCT DETAILS: Product Name Azithromycin Tablets IP Product Description White color, round shape,…
MFR of Paracetamol Oral Suspension IP (125 mg) TABLE OF CONTENTS SNO. TITLE Page No 1.0 PRODUCT DETAILS 2.0 MANUFACTURING FORMULA 3.0 LIST OF EQUIPMENT 4.0 GENERAL PRECAUTIONS 5.0 MANUFACTURING INSTRUCTIONS 6.0 MANUFACTURING PROCEDURE 7.0 FILLING AND PRIMARY PACKING DETAILS 8.0 SECONDARY AND TERTIARY PACKING PROCEDURE 9.0 FINISHED PRODUCT SAMPLING & ANALYSIS 10.0 SHIPPER STRIPING…
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Un-Planned Deviation Example Investigation Details for Incident No.:____________________________________ 1.0 Product details Name of product B. No. B. Size Batch stage Granulation (Lubrication) Investigation team member details Production Supervisor IPQA Production Manager QC Head Warehouse In Charge QA Head Incident details Lubricated granules of the batch containing API (Clobazam) and excipients (MCCP PH 102, Cross…
Un-Planned Deviation Deviation Investigation Report Description of Deviation: The document entry of dispensing and cleaning records is not recorded by the respective operators. Type of deviation: Un-Planned Deviation Class of Deviation: Minor Date of investigation: Department: Warehouse Date of deviation Observed: Investigations start date: Investigation completion date: INVESTIGATION TEAM S.No. Name Designation Department 1. Manager…
Entry & exit procedure in primary change room for personnel and visitors Objective To lay down a procedure for the entry and exit in primary change room for personnel and visitors. Scope This Standard Operating Procedure is applicable for all employees and visitors entering into the primary change room. Responsibility All employees and visitors of…
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