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Good Manufacturing Practices in Malaysia in 2026: NPRA GMP Inspection Guide

Learn how Malaysia GMP guidelines and NPRA GMP inspections align with PIC/S GMP requirements. This guide explains pharmaceutical quality systems, inspection priorities, common findings, CAPA expectations, and practical strategies to improve GMP compliance and inspection readiness.
  • Blog, Quality Management System
NPRA GMP inspection in a pharmaceutical manufacturing Malaysia facility following PIC/S GMP requirements and pharmaceutical quality system standards

US Reshoring Looks Promising; GMP Validation Could Be the Real Bottleneck

New analysis suggests that pharmaceutical tariffs alone may not achieve the reshoring goals many policymakers expect. According to legal and industry experts in the United States, the economics of generic drug manufacturing, combined with GMP compliance costs and validation requirements,
  • News
US Reshoring Looks Promising; GMP Validation Could Be the Real Bottleneck

Manufacturing Readiness Is Reshaping Pharma M&A; Why GMP Due Diligence Now Drives Deal Decisions

Pharmaceutical dealmaking slowed during the first half of 2026, yet industry experts say transaction quality has become more important than volume. Speaking with Pharmaceutical Technology, KPMG US Life Sciences Sector Leader Kristin Ciriello Pothier explained that manufacturers now place greater
  • News
Manufacturing Readiness Is Reshaping Pharma M&A; Why GMP Due Diligence Now Drives Deal Decisions

Jaypirca Wins CHMP Support; Why Europe Is Moving Toward All-Line CLL Treatment

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended Eli Lilly’s Jaypirca (pirtobrutinib) for approval to treat adults with chronic lymphocytic leukemia (CLL) across all lines of therapy, regardless of previous BTK inhibitor treatment. The
  • News
Jaypirca Wins CHMP Support; Why Europe Is Moving Toward All-Line CLL Treatment

Batch Record in Pharmaceutical Industry in 2026: GMP Documentation, QA Review, and Batch Release Control

This article explains batch manufacturing record systems in the pharmaceutical industry, focusing on GMP documentation requirements, QA review processes, and pharmaceutical batch release process. It also highlights FDA GMP inspection findings, ALCOA+ data integrity, and CFR Part 11 compliance controls.
  • Blog, Quality Management System
Batch production record workflow in pharmaceutical manufacturing illustrating GMP documentation requirements, QA batch record review process, deviation control, and electronic batch record system aligned with CFR Part 11 electronic records and data integrity ALCOA plus compliance.