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12 Articles

Computerised System Validation × Equipment Cleaning Validation × Utilities × Validation × Quality ×

Change Management

Change Management

* Introduction * Change is inevitable in the pharmaceutical industry, where advancements in technology, regulatory updates, and operational improvements constantly reshape the landscape. However, impl...

Quality

Jan 31, 2025

Self-inspection, quality audits

Self-inspection, quality audits

** Introduction: ** What is an Audit? According to ISO 19011, an audit is a systematic, independent, and documented process for obtaining objective evidence and evaluating it objectively to determine ...

Quality

Mar 27, 2024

Quality Management QMS

Quality Management QMS

** Introduction: ** At the heart of GMP lies the commitment to ensuring that medicinal and food products meet the quality standards necessary for their intended use. As stated in GMP guidelines, Qual...

Quality

Mar 26, 2024

Calibration Management

Calibration Management

** Introduction: ** In the highly regulated environments of pharmaceutical and food industries, precision and accuracy are paramount. Calibration management plays a pivotal role in ensuring that measu...

Calibration Equipment Validation

Jan 5, 2024

Process Validation

Process Validation

** Introduction: ** At the heart of pharmaceutical manufacturing lies the crucial process of validation. a comprehensive journey from defining a process to ensuring it consistently produces high-quali...

Validation

Dec 7, 2023

Computerised Systems

Computerised Systems

** Introduction: ** In the dynamic world of pharmaceuticals, the integration of computerized systems is not just a technological advancement; it's a critical component ensuring patient safety, product...

Computerised System Validation Validation

Dec 6, 2023

Cleaning Validation

Cleaning Validation

** Introduction: ** The key to pharmaceutical success lies not only in the development of groundbreaking drugs but also in the meticulous adherence to Good Manufacturing Practices (GMP). ...

Equiment Cleaning Procedure Equipment Cleaning Validation Validation

Nov 26, 2023

Pharmaceutical Water Systems

Pharmaceutical Water Systems

** Introduction: ** In the intricate world of pharmaceuticals, the quality of water used plays a crucial role in ensuring product safety and efficacy. Understanding the diverse grades of water and imp...

Facility Utilities

Nov 23, 2023

Heating,Ventilation and Air-Conditioning System

Heating,Ventilation and Air-Conditioning System

** Introduction: ** In the realm of pharmaceutical and food industries, precision and quality are non-negotiable. One crucial aspect that often remains behind the scenes but plays a pivotal role in en...

Facility Utilities

Nov 9, 2023

Utilities

Utilities

** Introduction: ** In the world of pharmaceuticals and food production, ensuring quality and safety is paramount. To achieve this, regulatory bodies have established Good Manufacturing Practices (GMP...

Utilities

Nov 2, 2023

Commissioning, Qualification, and Validation

Commissioning, Qualification, and Validation

Start writing here... *Introduction* In the realm of pharmaceutical manufacturing, quality and safety are of paramount importance. Adhering to Good Manufacturing Practices (GMP) is not merely a ...

Commissioning Facility Qualification Validation

Oct 12, 2023

Annual Product Review in Pharma

Safaa Abdel Wahab

Annual Product Review in Pharma

*Introduction:* In the pharmaceutical industry, adhering to Good Manufacturing Practices (GMP) regulations is paramount. These regulations necessitate the generation and analysis of a substantial volu...

Annual Product Review Quality

Oct 8, 2023

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Calibration Cleanrooms Commissioning Computerised System Validation Equiment Cleaning Procedure Equipment Equipment Cleaning Validation Facility Qualification Sanitization Procedures Utilities Validation

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Phrmaceutical Quality Systems

Quality

Quality

Annual Product Review