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Deviation Handling and Quality Risk Management As Per WHO

December 4, 2019January 29, 2023 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…

Uncategorized

Procedure for Operation & Cleaning of Mass Mixer

December 4, 2019March 16, 2023 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…

Production

Operation & Cleaning of Laser Printing Machine

December 1, 2019January 29, 2023 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…

Production

Operation & Cleaning of Induction Sealing Machine

December 1, 2019January 29, 2023 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…

Production

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

November 26, 2019January 29, 2023 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…

Quality Control

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

November 26, 2019January 29, 2023 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….

Quality Control

Procedure for calibration of conductivity meter (PICO)

November 26, 2019November 13, 2024 Pharma Editor

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…

Quality Control

Checklist in Quality control for Audit Preparation of FDA & USFDA

November 26, 2019January 29, 2023 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…

Audit and Guideline

Calibration of KARL FISCHER (METTLER TOLEDO)

November 26, 2019January 29, 2023 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…

Quality Control

LINE CLEARANCE CHECKLIST FOR VACUUM CLEANER

November 26, 2019November 18, 2021 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…

Audit and Guideline, Warehouse

Calibration procedure for friability test apparatus

November 24, 2019March 7, 2021 Pharma Editor

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. BA(II)QA202 Set display to 30…

Quality Control

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

November 24, 2019March 7, 2021 Pharma Editor

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. Fill the water in the…

Quality Control

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

November 24, 2019March 7, 2021 Pharma Editor

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 display test (all segments in…

Quality Control

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR PACKING LINE

November 24, 2019August 19, 2020 Pharmaceutical Guidanace

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 / Not Released / Hold /…

Uncategorized

BATCH MANUFACTURING RECORD (BMR)

November 5, 2019March 9, 2023 Pharmaceutical Guidanace

BATCH MANUFACTURING RECORD (BMR) TABLE OF CONTENT GENERAL PROCESSING INSTRUCTION LIST OF EQUIPMENT USED DISPENSING OF RAW MATERIAL GRANULATION COMPRESSION COATING TABLET INSPECTION DOCUMENT RECONCILIATION BMR REVIEW BATCH RELEASE 1.0 GENERAL PROCESSING INSTRUCTION All the Activities shall be performed as per current SOPs. Follow GMP compliance throughout the manufacturing process. Check and ensure that the…

Production

BATCH PACKING RECORD (BPR)

November 3, 2019November 15, 2023 Pharmaceutical Guidanace

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 _____________________________________ tablet contains: Batch No. …

Production

Procedure for operation of pH / CONDUCTIVITY METTLER (PICO)

November 1, 2019July 26, 2022 Pharma Editor

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 FOR CLEANING Check that the…

Quality Control

Operating procedure for milli Q water system

November 1, 2019July 26, 2022 Pharma Editor

OBJECTIVE To lay down the procedure for Operation of Milli Q water system, Make Millipore. SCOPE This SOP shall provide the Operating procedure of Milli – Q water system of quality control department. RESPONSIBILITY Officer/ Executive – Quality Control ACCOUNTABILITY Head QC/QA PROCEDURE OPERATION OF ELIX –10 Switch on Elix – 10 power supply button…

Quality Control

Procedure for operation of SAS SUPER 100 AIR SAMPLER

November 1, 2019July 26, 2022 Pharma Editor

OBJECTIVE To lay down a procedure for operation of SAS SUPER 100 Air sampler. SCOPE This SOP shall be applicable for viable air monitoring. RESPONSIBILITY Microbiologist ACCOUNTABILITY Head QC/QA PROCEDURE PRE START UP Remove the aspirating head. Insert an identified, closed contact plate and remove the lid of the plate. Replace the aspirating head. Operate…

Quality Control

Humidity Chamber

November 1, 2019March 1, 2024 Pharma Editor

Humidity chamber The purpose of humidity chambers is to test the influence of varying environments on products to determine the length of their usefulness and at what point they will fail. The collected data assists engineers in adjusting their designs and selecting more resilient materials. Humidity chambers play a crucial role in various industries, aiding…

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