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11 Articles

Cleanrooms × Equipment Cleaning Validation × Sanitization Procedures × 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

Cleanrooms in Pharmaceuticals Facilities

Cleanrooms in Pharmaceuticals Facilities

** Introduction: ** Cleanrooms play a pivotal role in pharmaceutical facilities, contributing to product safety, quality, and efficacy. These specialized environments are meticulously designed and mai...

Cleanrooms Facility

Oct 26, 2023

Sanitization Procedures

Sanitization Procedures

** Introduction: ** In the world of pharmaceutical and food manufacturing, ensuring the highest level of product safety is paramount. The Good Manufacturing Practices (GMP) standards, established by t...

Facility Sanitization Procedures

Oct 19, 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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Infrastructure, Facility, and Utilities

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

Laboratory Systems

Specifications

Phrmaceutical Quality Systems

Quality

Quality

Annual Product Review