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7 المقالات

Computerised System Validation × Equiment Cleaning Procedure × Specifications × Quality ×

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

يناير 31, 2025

user

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

مارس 27, 2024

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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

مارس 26, 2024

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Specifications

** Introduction: ** Adherence to Good Manufacturing Practices (GMP) is crucial to ensure the safety, efficacy, and quality of products. Specifications are critical quality standards that are proposed...

Specifications

مارس 14, 2024

user

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

ديسمبر 6, 2023

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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

نوفمبر 26, 2023

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

أكتوبر 8, 2023

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الوسوم

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

Annual Product Review

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الوسوم