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Pharmaceutical Guidanace

Things to Do When FDA Staff Are on Site to Conduct an Inspection

The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection FDA Expectations • FDA conducts inspections to assess compliance with applicable laws and regulations • FDA expects: – Investigators to conduct inspections in a reasonable manner – Industry to …

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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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Procedure for Operation & Cleaning of Mass Mixer.

1.0       OBJECTIVE:             To Lay Down the Procedure for Operation & Cleaning of Mass Mixer. 2.0       SCOPE:             This SOP is applicable for production Department for Operation & Cleaning of Mass Mixer            3.0       RESPONSIBILITY: 3.1       Officer production & QA personnel shall be responsible for this SOP. …

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Operation & Cleaning of Laser Printing Machine.

1.0       OBJECTIVE:             To Lay Down the  Procedure for Operation & Cleaning of Laser Printing Machine. 2.0       SCOPE: This SOP is applicable for production Department for Operation & Cleaning of Laser Printing Machine   3.0       RESPONSIBILITY: 3.1       Officer production & QA personnel shall be responsible for …

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Operation & Cleaning of Induction Sealing Machine

1      OBJECTIVE: To Lay Down the  Procedure for Operation & Cleaning of Induction Sealing Machine.   2.0       SCOPE: This SOP is applicable for production  Department for Operation & Cleaning of Induction Sealing Machine   3.0       RESPONSIBILITY: 3.1       Officer production & QA personnel shall be responsible …

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Checklist in Quality control for Audit Preparation of FDA & USFDA

Checklist in Quality control for Audit Preparation of FDA & USFDA Personnel Organogram of Quality control departments List of Employee and education details Individual Job Description Training Record of Individual employee as per   individual Job Responsibility  and Training Log and training assessments records Analyst Qualification records as per  individual Job Responsibility and  …

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LINE CLEARANCE CHECKLIST FOR VACUUM CLEANER

LINE CLEARANCE CHECKLIST FOR VACUUM CLEANER Dosage Form: Date / Time: Product: Batch No.  : Previous Product: Batch No.  : Vacuum cleaner ID No.: Stage areas / room & equipment Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time Vacuum cleaner Equipment ID No.: …

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LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR PACKING LINE

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR PACKING 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 PACKING [Released / …

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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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