GMP Trends and Analyses!

The leading journal for specialists and managers in pharmaceutical manufacturing and quality assurance

 ICH Q7 Training Week

ICH Q7 Training Week

Data Integrity in the Light of ICH Q7.

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Analytical Instrument Qualification and System Validation

Analytical Instrument Qualification and System Validation

The ECA Analytical Quality Control Group's News Guide. Please read more here

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Pharmaceutical contracts and their importance for the Qualified Person

Pharmaceutical contracts and their importance for the Qualified Person

Pharmaceutical contracts are of great importance not only for the delimitation of general and specific contractual issues in the working relationship. Please read more here

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Use of Artificial Intelligence in the 100% Visual Inspection of Parenterals

Use of Artificial Intelligence in the 100% Visual Inspection of Parenterals

Artificial intelligence and machine learning have the potential to change patient care in the healthcare sector. Please read more here

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GMP Hot Spots as seen in the Warning Letters - Stability Testing

GMP Hot Spots as seen in the Warning Letters - Stability Testing

Stability tests on finished medicinal products and their components, active ingredients and excipients, are an essential part of GMP-compliant manufacturing. Please read more here

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Audit trail in EU GMP Annex 11 and EMA Concept Paper on Annex 11

Audit trail in EU GMP Annex 11 and EMA Concept Paper on Annex 11

Every change to an entry in a document should be signed and dated. Despite the change, the original information should remain legible. Please read more here

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Development of modern pharmaceuticals, vaccines and more

Development of modern pharmaceuticals, vaccines and more

Part 1: Advanced Therapy Medicinal Products (ATMPs) - cell and gene therapies. Please read more here

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