Tag: Rutland

SOP for cleaning of sticker labeling machine (Maharshi)

Posted on By Pharma Editor

SOP for cleaning of sticker labeling machine (Maharshi) Objective: To lay down a procedure for cleaning of sticker labeling machine. Scope This SOP is applicable for the cleaning of sticker labeling machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. MASTER FORMULA OF COLD TABLETS Cleaning Procedure At…

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Production

SOP for operation & cleaning of electronic balance 50Kgs (lakshmi Samson)

Posted on By Pharma Editor

SOP for operation & cleaning of electronic balance 50Kgs (lakshmi Samson) Objective: To lay down a procedure for operation & cleaning of electronic balance 50kgs (Make Lakshmi Samson) Scope This SOP is applicable for operation & cleaning of electronic balance 50kgs (Make Lakshmi Samson). Responsibility Production officer/ Executive Accountability Production Head shall be accountable for…

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Production

SOP for operation & cleaning of electronic balance 3 Kgs (lakshmi Samson)

Posted on By Pharma Editor

SOP for operation & cleaning of electronic balance 3 Kgs (lakshmi Samson) Objective: To lay down a procedure for operation & cleaning of electronic balance 3 kgs (Make Lakshmi Samson) Scope This SOP is applicable for operation & cleaning of electronic balance 3 kgs (Make Lakshmi Samson). Responsibility Production officer/ Executive Accountability Production Head shall…

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Production

SOP on cleaning of Aspirator assembly and disposal of waste raw material collected during filling operation.

Posted on By Pharma Editor

SOP on cleaning of Aspirator assembly and disposal of waste raw material collected during filling operation. Objective  To lay down the procedure for cleaning of aspirator assembly and disposal of waste raw material collected during filling operation. Scope This SOP is applicable for cleaning of aspirator assembly and disposal of waste raw material in Dry…

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Production

SOP for cleaning of PVC flaps of Laminar Air Flow

Posted on By Pharma Editor

SOP for cleaning of PVC flaps of Laminar Air Flow To lay down a procedure for cleaning of PVC flaps of Laminar Air Flow. Objective: Scope This SOP is applicable for cleaning of PVC flaps of Laminar Air Flow. Responsibility Production operator / Technician – responsible for operation of cleaning of PVC flaps of Laminar…

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Production

Operational Qualification of Vertical Laminar Reverse flow Containment Station

Posted on By Pharma Editor

PURPOSE: To describe the Operational Qualification of Vertical Laminar Reverse flow Containment Station, its accessories and to define the specification of the system in order to: Ensure that the equipment meets the Operational/Design limits as per user requirements. Ensure that the equipment will be operationally qualified in accordance with current Good Manufacturing Practices SCOPE: The…

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Uncategorized

Installation Qualification of Vertical Laminar Reverse Flow Containment Station

Posted on By Pharma Editor

PURPOSE To describe the Installation Qualification of Vertical Laminar Reverse Flow Containment Station and to define the Specification of the system in order to: Ensure that the equipment meets the specification as per Design Qualification. Aid verification of the installation as per equipment general arrangement drawing. Ensure that the system installation meets acceptance criteria. Ensure…

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Uncategorized

Operational Qualification of Medicament Preparation Vessel

Posted on By Pharma Editor

PURPOSE: To describe the Operational Qualification of Medicament Preparation Vessel, its accessories and to define the specification of the system in order to: ensure that the equipment meets the Operational/Design limits as per user requirements. ensure that the equipment shall be operationally qualified in accordance with current Good Manufacturing Practices. SCOPE: The scope of this…

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Uncategorized

Installation Qualification of Raw Gelatin Storage Vessel

Posted on By Pharma Editor

PURPOSE: To describe the Installation Qualification of Raw Gelatin Storage Vessel its accessories and to define the Specification of the system in order to: Ensure that the equipment meets the specification as per Design Qualification. Aid verification of the installation as per equipment general arrangement Drawing. Ensure that the system installation meets acceptance criteria. Ensure…

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Uncategorized

Installation Qualification of Aluminium Strip Defoiler

Posted on By Pharma Editor

PURPOSE To describe the Installation Qualification procedure to be used during qualification of Aluminium Strip Defoiler to define the Specification of the system in order to: Ensure that the equipment meets the specification as per Design Qualification. Ensure that the system installation meets acceptance criteria Ensure that the equipments will be installed in accordance with…

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Uncategorized

Deviation Handling and Quality Risk Management As Per WHO

Posted on By Pharmaceutical Guidanace

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 avoided by implementing risk control…

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QA & QC

Procedure for Operation & Cleaning of Mass Mixer

Posted on By Pharmaceutical Guidanace

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…

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Production

Operation & Cleaning of Laser Printing Machine

Posted on By Pharmaceutical Guidanace

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…

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Production

Operation & Cleaning of Induction Sealing Machine

Posted on By Pharmaceutical Guidanace

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…

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Production

Calibration procedure for tap density apparatus [Make- electro Lab]. Quality assurance

Posted on By Pharma Editor

OBJECTIVE To lay down the procedure for Calibration of Tap density apparatus, Make – Electro lab. SCOPE This SOP shall provide the Calibration procedure of Tap density apparatus of quality control department. RESPONSIBILITY Officer/ Executive – Quality Control ACCOUNTABILITY Head QC/QA PROCEDURE Before starting the operation check for the area cleanliness and instrument cleanliness. Connect…

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QA & QC, Quality Control

Procedure for operation and calibration of IR Spectro Photometer (SHIMADZU). Quality assurance

Posted on By Pharma Editor

OBJECTIVE To lay down the procedure for operation and calibration of Fourier Transform Infrared Spectrophotometer (Shimadzu) SCOPE This SOP shall be applicable for Quality Control in Quality Assurance department. RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Head Quality Control. PROCEDURE FOR CLEANING Check that the power supply to the instrument is switched ‘ OFF ‘ before cleaning….

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QA & QC, Quality Control

Procedure for calibration of conductivity meter (PICO)

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Procedure for calibration of conductivity meter (PICO) OBJECTIVE To lay down the procedure for calibration of pH / CONDUCTIVITY METER (PICO) SCOPE This Standard Operating Procedure (SOP) is applicable for pH meter (PICO).  RESPONSIBILITY Quality Control Executive / Officer. ACCOUNTABILITY Quality Control   Manager PROCEDURE Operate the Instrument as per procedure no.   BA(II)QA217 Calibrate the instrument…

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QA & QC, Quality Control

Checklist in Quality control for Audit Preparation of FDA & USFDA

Posted on By Pharmaceutical Guidanace

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  Organogram Specimen Signature log of…

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Audit and Guideline

Calibration of KARL FISCHER (METTLER TOLEDO)

Posted on By Pharma Editor

OBJECTIVE To lay down the procedure for CALIBRATION of KARL FISCHER (METTLER TOLEDO) SCOPE To ensure that the instrument performs satisfactory and gives accurate and reproducible data. This SOP shall be applicable for the KARL FISCHER APPARATUS (METTLER TOLEDO). RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Quality Control Manager. PROCEDURE FOR CLEANING Check that the power supply…

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QA & QC, Quality Control

LINE CLEARANCE CHECKLIST FOR VACUUM CLEANER

Posted on By Pharmaceutical Guidanace

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.: _______________ Ensure the absence of…

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Audit and Guideline, Warehouse