Recent Posts

Operational Qualification of Medicament Preparation Vessel

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. …

Read More »

Installation Qualification of Raw Gelatin Storage Vessel

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 …

Read More »

Installation Qualification of Aluminium Strip Defoiler

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 …

Read More »

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 …

Read More »

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. …

Read More »

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 …

Read More »

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 …

Read More »

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

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 …

Read More »

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

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 …

Read More »

Procedure for calibration of conductivity meter (PICO). Quality Assurance

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 by preparing …

Read More »

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  …

Read More »

Calibration of KARL FISCHER (METTLER TOLEDO). Quality assurance

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 …

Read More »

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.: …

Read More »

Calibration procedure for friability test apparatus. Quality assurance

OBJECTIVE To lay down a procedure for Calibration of Friability Test Apparatus to give accurate and reproducible data. SCOPE This Standard Operating Procedure (SOP) is applicable to In process samples. RESPONSIBILITY IPQA / Production Executive / Officer  ACCOUNTABILITY Head–Quality Assurance PROCEDURE Operate the Friability test apparatus as per SOP No.  …

Read More »

Calibration procedure for disintegration test apparatus (ED-2AL). Quality assurance

OBJECTIVE To lay down a procedure for Calibration of Disintegration test apparatus SCOPE This Standard Operating Procedure (SOP) is applicable to DT apparatus placed in IPQC lab and in Quality Control. RESPONSIBILITY IPQA / Production Executive / Officer  ACCOUNTABILITY Head–Quality Assurance PROCEDURE Check the water level in the water bath. …

Read More »

Procedure for operation of weighing balance (Make: METTLER TOLEDO). Quality assurance

OBJECTIVE To lay down a procedure for Operation of weighing balance PB-303S. SCOPE This Standard Operating Procedure (SOP) shall be applicable for weighing balances installed in sampling booth. RESPONSIBILITYQuality Control Officer / Executive ACCOUNTABILITY Head – Quality Assurance\ PROCEDURE On/off switching Press < IB> key briefly. The balance performs a …

Read More »

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 / …

Read More »

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 …

Read More »

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 …

Read More »

Procedure for operation of pH / CONDUCTIVITY METTLER (PICO)

OBJECTIVE To lay down the procedure for operation of pH / Conductivity meter (PICO) SCOPE To ensure that the instrument performs satisfactory and gives accurate and reproducible data. This SOP shall be applicable for the pH / Conductivity meter (PICO). RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Quality Control Manager. PROCEDURE PROCEDURE …

Read More »