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Tag: Quality Management System

Annual Product Review (APQR / APR / PQR)

September 12, 2020 Admin Leave a comment

Annual Product Review (APR) is the requirement of various regulatory agencies. APR roots the monitoring of product quality as well…

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Posted in: Quality Assurance Filed under: Annual Product Review, Quality Management System

European Guidance On:
HOW TO CARRY OUT A RISK ASSESSMENT

July 23, 2020 Admin Leave a comment

At EU-level there are not fixed rules about how risk assessments should be undertaken (you should check the specific legislation…

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Posted in: Quality Assurance Filed under: Pharmaceutical Quality System, Quality Assurance, Quality Management System

CAPA PROCESS – STEP-BY-STEP INSTRUCTIONS

July 17, 2020 Admin Leave a comment

CAPA (Corrective Action & Preventive Action) is an area that we talk about often, mainly because it’s still such a…

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Posted in: Quality Assurance Filed under: CAPA, QMS, Quality Assurance, Quality Management System, Steps of CAPA

Quality management system for Laboratory Management in Pharma

July 15, 2020 Admin Leave a comment

The laboratory or Quality organization management should establish, implement and maintain a quality management system appropriate to the scope of…

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Posted in: Quality Control Filed under: Laboratory Management, Quality Assurance, Quality Control, Quality Management System

Handling of Pharmaceutical Market Complaint

May 17, 2020 Admin Leave a comment

Principle. All complaints and other information concerning potentially defective products should be carefully reviewed according to written procedures and the…

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Posted in: Quality Assurance Filed under: Pharmaceutical Market Complaint, Quality Assurance, Quality Management System

SOP For Risk Management

February 1, 2019 Admin 13 Comments

SOP For Risk Management. Objective :- The purpose of this SOP is to lay out the procedure for Risk Management…

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Posted in: Uncategorized Filed under: Quality Assurance, Quality Management System, Risk Management, SOP

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Analyst Qualification Antibiotic Potency Testing Audit Preparation CAPA Change Management System Cleaning Validation Compression Machine Data Integrity EU Audit Requirements FDA Warning Letter HPLC Calibration ICH Guideline ICH Q10 laboratory guideline Manufacturing Site MHRA Microbial Testing Microbiology Microbiology SOP Microbiology Techniques OOS Out of Specification Out of Trend Pharmaceutical Production Pharmaceutical Quality System Phase-I Phase-II Phase Ia Phase Ib production Production SOP QMS Qualifications Protocol Qualification  Steps Quality Assurance Quality Control Quality Control Laboratory Quality Control SOP Quality Management System SOP SOP for Qualification of Quality Control analyst Stability Study Sterile Pharmaceutical products Sterility Testing USFDA
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