as of 2019 - 03 - 18
2018
What’s New in Update No. 9/2018?
GMP in Practice
Chapter 2 Personnel
Chapter 10 Hygiene
GMP Regulations
Chapter C EU Directives and Guidelines
Chapter E ICH-Guidelines
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What’s New in Update No. 8/2018?
GMP in Practice
Chapter 1 Quality Management System (PQS)
GMP Regulations
Chapter H WHO Guidelines
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What’s New in Update No. 7/2018?
GMP in Practice
Chapter 4 Facilities and equipment
Chapter 24 Storage and Transportation
GMP Regulations
Chapter D USA: CFR and FDA Guidelines
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What’s New in Update No. 6/2018?
GMP in Practice
Chapter 5 Pharmaceutical Water
Chapter 14 Laboratory Controls
GMP Regulations
Chapter C EU Directives and Guidelines
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What’s New in Update No. 5/2018?
GMP in Practice
Chapter 24 Storage and Transportation
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What’s New in Update No. 4/2018?
GMP in Practice
Chapter 14 Laboratory Controls
14.N Determining and reporting numerical test results in pharmaceutical quality control
Chapter 15 Documentation
15.D Standard Operating Procedures (SOPs)
GMP Regulations
Chapter C EU Directives and Guidelines
C.5 EU GMP Guide Part II: Basic Requirements for Active Substances used as Starting Materials combined with GMP for APIs: “How to do“ Document by APIC/CEFIC Interpretation of the ICH Q7 Guide
C.8.6.1 Questions and answers on implementation of risk-based prevention of cross-contamination in production and ‘Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’
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What’s New in Update No. 3/2018?
GMP in Practice
Chapter 3 Premises
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What’s New in Update No. 2/2018?
GMP in Practice
Chapter 6 Qualification
GMP Regulations
Chapter E ICH Guidelines
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What’s New in Update No. 1/2018?
GMP Regulations
Chapter C EU Directives and Guidelines
Chapter D USA: CFR and FDA Guidelines
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