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8 Articles

Cleanrooms × Computerised System Validation × Equipment Cleaning Validation × Specifications × Quality ×

Change Management

Quality

Jan 31, 2025

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

** 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

** 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

** 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

** 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

** 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

Annual Product Review in Pharma

Annual Product Review Quality

Oct 8, 2023

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