Insights
Insights & Guidance
Practical articles on GMP compliance, inspection readiness, data integrity, supplier qualification and regulatory developments, written for quality and regulatory professionals in regulated industries.
FDA Inspection Readiness: What Inspectors Are Currently Looking For
FDA inspection priorities have shifted significantly in recent years. Data integrity, contamination control strategy and supply chain oversight are among the areas receiving the greatest regulatory scrutiny. This article sets out what organisations should be assessing before an FDA inspector arrives.
Read article →Top GMP Findings in Pharmaceutical Supplier Audits
Across supplier qualification audits conducted in 2025, a consistent pattern of findings emerges. This article analyses the most frequently observed GMP deficiencies in API suppliers, CDMOs and packaging material manufacturers, and the systemic causes behind them.
Read article →Supplier Qualification Best Practices: Beyond the Audit
Effective supplier qualification extends far beyond the initial audit. This article examines the quality agreement requirements, change notification obligations and periodic reassessment programmes that distinguish compliance-focused supplier management from paper-based approval processes.
Read article →Data Integrity Assessment Guide: ALCOA+ in Practice
ALCOA+ provides the framework, but applying it to real pharmaceutical quality control and manufacturing environments requires practical interpretation. This guide walks through each ALCOA+ principle with specific examples of the controls and system configurations that demonstrate compliance.
Read article →GDP Audit Preparation: A Practical Guide for Wholesale Dealers
Wholesale dealer licence holders face inspection by national competent authorities with increasing frequency. This guide covers the key GDP compliance areas that inspectors focus on, from storage facility qualification and temperature mapping to Responsible Person oversight and FMD verification.
Read article →EU Annex 11 Compliance: What Has Changed and What Organisations Need to Do
EU GMP Annex 11 establishes the requirements for computerised systems in pharmaceutical manufacturing. This article examines the key requirements of Annex 11 in the context of current regulatory expectations and the most common gaps identified during CSV and data integrity assessments.
Read article →GAMP 5 Second Edition: Key Changes and Their Implications
The second edition of GAMP 5 (2022) introduced significant updates to the framework for computer system validation in regulated environments. This article summarises the most important changes and their practical implications for organisations managing validation programmes in pharmaceutical facilities.
Read article →EU MDR Transition: Common Gaps in Technical Documentation
Despite the extended transition timeline, many medical device manufacturers still have technical documentation that does not meet EU MDR standards. This article examines the most common gaps identified in MDR technical documentation reviews, and the practical steps manufacturers can take to address them.
Read article →Stay Current
The regulatory environment for pharmaceutical and medical device organisations continues to evolve. New FDA guidance documents, EMA inspection trend publications, MHRA policy updates and ICH guideline revisions each change the compliance landscape for regulated organisations.
Sthira Assure publishes practical guidance grounded in direct regulatory experience, not marketing content or generic commentary. Our articles are written for quality and regulatory professionals who need substantive, actionable information.
Topics We Cover
- GMP Compliance and Inspection Trends
- Data Integrity and ALCOA+
- Supplier Qualification Programmes
- GDP and Cold Chain Compliance
- Computer System Validation (GAMP 5)
- EU MDR and Medical Device Regulations
- FDA Regulatory Intelligence
- Inspection Readiness
Have a Compliance Question?
Speak with our team directly about your regulatory and compliance challenges.
Request a Consultation