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7 Articles

Commissioning × Computerised System Validation × Qualification × Specifications × 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

Specifications

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

Mar 14, 2024

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

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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Annual Product Review