The Most Requested Pharmaceutical Guides on Quality, Compliance, and GMP

ISO 14644-5:2025 – Operational Guide to Cleanroom Operations (Checklists & Audit Ready)

ISO 14644-5:2025 – Operational Guide to Cleanroom Operations (Checklists & Audit Ready)

Regular price €129,00 EUR

Regular price Sale price €129,00 EUR
Operational Guide to GMP Cleaning Validation

Operational Guide to GMP Cleaning Validation

Regular price €149,00 EUR

Regular price Sale price €149,00 EUR
USP 382 – Implementation Guide for Parenteral Closure Systems

USP 382 – Implementation Guide for Parenteral Closure Systems

Regular price €199,00 EUR

Regular price Sale price €199,00 EUR
Operational Guide to GMP Annexes 1, 15, 16 and 20 – With Best Practices

Operational Guide to GMP Annexes 1, 15, 16 and 20 – With Best Practices

Regular price €89,00 EUR

Regular price Sale price €89,00 EUR
SOP – Analytical Method Validation (AMV)

SOP – Analytical Method Validation (AMV)

Regular price €39,00 EUR

Regular price Sale price €39,00 EUR
SOP: Self-Inspections in the Pharmaceutical Sector

SOP: Self-Inspections in the Pharmaceutical Sector

Regular price €39,00 EUR

Regular price Sale price €39,00 EUR
Application Guide to the ISO 14644 Series for the Pharmaceutical Industry

Application Guide to the ISO 14644 Series for the Pharmaceutical Industry

Regular price €49,00 EUR

Regular price Sale price €49,00 EUR
Internal GMP Audits: how to make them effective, risk-based, and defensible during AIFA/FDA/EMA inspections

Internal GMP Audits: how to make them effective, risk-based, and defensible during AIFA/FDA/EMA inspections

Regular price €129,00 EUR

Regular price Sale price €129,00 EUR
Extractables & Leachables (E&L) GMP – Risk-Based Operational Guide for Defensible Decisions in FDA/EMA Audits

Extractables & Leachables (E&L) GMP – Risk-Based Operational Guide for Defensible Decisions in FDA/EMA Audits

Regular price €139,00 EUR

Regular price Sale price €139,00 EUR
Validation Master Plan (VMP) GMP: How to Govern Validation and Defend It in EMA, AIFA, FDA and PIC/S Audits

Validation Master Plan (VMP) GMP: How to Govern Validation and Defend It in EMA, AIFA, FDA and PIC/S Audits

Regular price €149,00 EUR

Regular price Sale price €149,00 EUR
GMP Deviations & CAPA: Effective Implementation and Audit Defensibility (EU GMP, FDA, AIFA, ICH Q10)

GMP Deviations & CAPA: Effective Implementation and Audit Defensibility (EU GMP, FDA, AIFA, ICH Q10)

Regular price €149,00 EUR

Regular price Sale price €149,00 EUR

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ISO 14644-5:2025 – Operational Guide to Cleanroom Operations (Checklists & Audit Ready)

ISO 14644-5:2025 – Operational Guide to Cleanroom Operations (Checklists & Audit Ready)

Operational Guide to GMP Cleaning Validation

Operational Guide to GMP Cleaning Validation

USP 382 – Implementation Guide for Parenteral Closure Systems

USP 382 – Implementation Guide for Parenteral Closure Systems

Operational Guide to GMP Annexes 1, 15, 16 and 20 – With Best Practices

Operational Guide to GMP Annexes 1, 15, 16 and 20 – With Best Practices

SOP – Analytical Method Validation (AMV)

SOP – Analytical Method Validation (AMV)

SOP: Self-Inspections in the Pharmaceutical Sector

SOP: Self-Inspections in the Pharmaceutical Sector

Application Guide to the ISO 14644 Series for the Pharmaceutical Industry

Application Guide to the ISO 14644 Series for the Pharmaceutical Industry

Internal GMP Audits: how to make them effective, risk-based, and defensible during AIFA/FDA/EMA inspections

Internal GMP Audits: how to make them effective, risk-based, and defensible during AIFA/FDA/EMA inspections

Extractables & Leachables (E&L) GMP – Risk-Based Operational Guide for Defensible Decisions in FDA/EMA Audits

Extractables & Leachables (E&L) GMP – Risk-Based Operational Guide for Defensible Decisions in FDA/EMA Audits

Validation Master Plan (VMP) GMP: How to Govern Validation and Defend It in EMA, AIFA, FDA and PIC/S Audits

Validation Master Plan (VMP) GMP: How to Govern Validation and Defend It in EMA, AIFA, FDA and PIC/S Audits

GMP Deviations & CAPA: Effective Implementation and Audit Defensibility (EU GMP, FDA, AIFA, ICH Q10)

GMP Deviations & CAPA: Effective Implementation and Audit Defensibility (EU GMP, FDA, AIFA, ICH Q10)

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