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Pharmaceutical Development as per USFDA

PHARMACEUTICAL DEVELOPMENT I. INTRODUCTION II. PHARMACEUTICAL DEVELOPMENT A. Components of the Drug Product 1. Drug Substance 2. Excipients B. Drug Product 1. Formulation Development 2. Overages 3. Physicochemical and Biological Properties C. Manufacturing Process Development D. Container Closure System E. Microbiological Attributes F. Compatibility III. GLOSSARY   INTRODUCTION The Pharmaceutical …

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

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 …

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Deviation Handling and Quality Risk Management As Per WHO

Deviation Handling and Quality Risk Management This  guidance Based on WHO recommended requirements, these documents provide further explanations with examples in order to facilitate implementation. Deviation handling Quality Risk Management was mainly designed to be used prospectively when manufacturing operations are defined and validated. The potential deviations are identified and …

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BATCH MANUFACTURING RECORD (BMR)

BATCH MANUFACTURING RECORD (BMR) BATCH MANUFACTURING RECORD (BMR) BMR Title : BMR for Tablet Document No. : BMR/TB/001-00 Batch Size :   Page No. :  1 of 29   Effective Date :   Review Date : Product Name                         :  Generic Name                         :  Labels Claim)                         : Each …

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BATCH PACKING RECORD (BPR)

BATCH PACKING RECORD (BPR) BATCH PACKING RECORD (BPR) BMR Title : BPR for Tablet Document No. : Batch Size :   Page No. :  1 of 15   Effective Date :   Review Date : Product Name                         :   Generic Name                         :   Labels Claim)                         : Each …

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Alu Alu Blister Pack Machine

Alu Alu Blister Pack Machine Sr. No. Table of Contents 1 General 2 Salient Features 3 Operational Requirements 4 Utilities 5 Maintenance 6 Commissioning and Documentation 7 Training 8 Packaging 9 Deviations 10 Delivery TECHNICAL  S. No. Parameters Required Specifications 1.        General  Equipment No. Description Use   Field Identification …

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Flow Chart and Manufacturing Procedure of Dextromethorphan Hydrobromide, Chlorphenamine Maleate & Phenylephrine Hydrochloride Flavoured Dispersible Tablets

Flow Chart and Manufacturing Procedure of Dextromethorphan Hydrobromide, Chlorphenamine Maleate & Phenylephrine Hydrochloride Flavoured Dispersible Tablets Bill of Material Ingredient Quantity in kg Dextromethorphan Hydrobromide and Chlorphenamine Maleate complex 12.12*# Phenylephrine Hydrochloride complex 8.08**# Mannitol (Pearlitol SD200, Roquette) 42.80 Silica, Colloidal Anhydrous 2.00 Indion 294 3.00 Talc 0.50 Magnesium Stearate …

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LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR PRIMARY PACKING

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR PRIMARY PACKING Dosage Form: Date / Time: Product: Batch No.  : Previous product: Batch No.  :   Stage areas / Equipment Name Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time PACKING [Released / Not Released …

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LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR INSPECTION LINE

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR INSPECTION LINE Dosage Form: Date / Time: Product: Batch No.  : Previous product: Batch No.  : Stage areas / Equipment Name Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time INSPECTION [Released / Not Released / …

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