Pharma GMP

How PIC/S Enhances GMP Harmonization Across Borders

digi — Fri, 13 Jun 2025 18:26:47 +0000

How PIC/S Enhances GMP Harmonization Across Borders Enhancing Cross-Border GMP Harmonization Through PIC/S Good Manufacturing Practice (GMP) compliance is the cornerstone of pharmaceutical quality. As the global pharmaceutical landscape becomes increasingly interconnected, the need for consistent inspection standards across borders has never been more crucial. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) plays a transformative role...

Objectives and Scope of PIC/S in Global GMP

digi — Fri, 13 Jun 2025 13:01:08 +0000

Objectives and Scope of PIC/S in Global GMP PIC/S: Objectives and Global Scope in GMP Harmonization With pharmaceutical manufacturing becoming increasingly globalized, consistent oversight of quality and compliance is critical. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) serves as a key international initiative that aims to harmonize Good Manufacturing Practice (GMP) inspections across regulatory authorities. This...

Avoid Water Stagnation in GMP Drains and Sinks to Prevent Contamination

digi — Fri, 13 Jun 2025 08:23:45 +0000

Avoid Water Stagnation in GMP Drains and Sinks to Prevent Contamination Prevent Water Stagnation in Drains and Sinks to Avoid Microbial Risk Remember: Water stagnation in GMP areas is a major source of microbial growth—ensure drains and sinks are regularly inspected, cleaned, and dried. Why This Matters in GMP Standing water is a fertile breeding...

PIC/S Membership: Countries and Agencies Involved

digi — Fri, 13 Jun 2025 05:25:51 +0000

PIC/S Membership: Countries and Agencies Involved Global Reach of PIC/S: Member Countries and Regulatory Agencies Involved The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a premier international platform that fosters harmonized Good Manufacturing Practice (GMP) inspections across regulatory authorities. Its strength lies in its diverse, global membership of competent authorities committed to cooperation, mutual trust, and...

Introduction to the Pharmaceutical Inspection Co-operation Scheme (PIC/S)

digi — Fri, 13 Jun 2025 00:41:59 +0000

Introduction to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Understanding PIC/S: A Gateway to Global GMP Inspection Harmonization In an era where pharmaceutical manufacturing and supply chains are increasingly global, the need for regulatory cooperation is paramount. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has emerged as a cornerstone organization driving harmonization of Good Manufacturing Practice (GMP)...

Test Compressed Air for Microbial Contamination in GMP Utilities

digi — Thu, 12 Jun 2025 21:27:36 +0000

Test Compressed Air for Microbial Contamination in GMP Utilities Verify Compressed Air for Microbial Contamination in GMP Operations Remember: Compressed air used in manufacturing must be monitored routinely for microbial and particulate contamination to ensure utility integrity. Why This Matters in GMP Compressed air is extensively used in pharmaceutical manufacturing—for equipment operation, product contact applications,...

EMA’s Harmonization with WHO PQP and PIC/S

digi — Thu, 12 Jun 2025 18:52:47 +0000

EMA’s Harmonization with WHO PQP and PIC/S How EMA Harmonizes GMP Standards with WHO PQP and PIC/S As pharmaceutical markets expand and supply chains globalize, regulatory convergence is becoming essential. The European Medicines Agency (EMA) actively collaborates with international bodies to harmonize inspection standards, align GMP expectations, and reduce duplication of effort. Two major platforms...

EMA GMP Inspection Templates and Tools

digi — Thu, 12 Jun 2025 12:15:08 +0000

EMA GMP Inspection Templates and Tools Standardized Templates and Tools for EMA GMP Inspections Good Manufacturing Practice (GMP) inspections carried out by the European Medicines Agency (EMA) and national competent authorities (NCAs) follow a structured, harmonized approach. To ensure consistency and completeness, regulators use a series of predefined templates and inspection tools that guide both...

Always Perform Swab Sampling After Cleaning Validation

digi — Thu, 12 Jun 2025 11:37:29 +0000

Always Perform Swab Sampling After Cleaning Validation Conduct Swab Sampling Post Cleaning Validation to Confirm Effectiveness Remember: Swab sampling must be performed after cleaning validation to ensure no residues or contaminants remain before equipment reuse. Why This Matters in GMP Cleaning validation establishes that manufacturing equipment can be cleaned to a predetermined level of cleanliness....

EMA GMP in Advanced Therapy Medicinal Products (ATMPs)

digi — Thu, 12 Jun 2025 05:40:18 +0000

EMA GMP in Advanced Therapy Medicinal Products (ATMPs) EMA’s GMP Framework for Advanced Therapy Medicinal Products (ATMPs) Advanced Therapy Medicinal Products (ATMPs) — including gene therapies, somatic cell therapies, and tissue-engineered products — represent one of the most innovative and complex sectors in modern medicine. Their highly personalized, high-risk nature requires tailored regulatory oversight. The...