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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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LINE CLEARANCE CHECKLIST FOR DISPENSING BOOTH

LINE CLEARANCE CHECKLIST FOR DISPENSING BOOTH   Dosage Form: Date / Time: Product: Batch No.  : Previous Product: Batch No.  : Dispensing Booth No.:  Sr. No. Check points  Observations  Done  By Checked by  Verified   By QA Active Excipient Colour Production Warehouse Room Identification number: 1 Ensure the absence of batch …

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LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT GRANULATION

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

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LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR BINDER PREPARATION

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

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