Pharma & GMP
Pharmaceutical quality assurance, GMP and GxP compliance, data integrity and inspection readiness.
37 articles
- GMP Data Integrity Checklist: ALCOA+, Audit Trails and 2026 Expectations 15% of 2025 FDA drug warning letters cited data integrity. Use this GMP data integrity checklist based on FDA, MHRA and the 2025 EU Annex 11 draft.
- ICH Q9(R1) Quality Risk Management Template: What Changed and How to Apply It ICH Q9(R1) tackles subjectivity, formality and drug shortages. Use this quality risk management template to apply the revision in 2026.
- What Is GMP? Good Manufacturing Practice Explained for 2026 GMP explained: what current good manufacturing practice means, which rules apply, the citations FDA issues most, and what changed in 2025 and 2026.
- Pharmaceutical Manufacturing in 2026: Onshoring, Advanced Manufacturing and What FDA Expects Pharmaceutical manufacturing in 2026: Section 232 tariffs, FDA PreCheck, advanced manufacturing designations and the GMP work new US plants need.
- GxP Compliance: What GMP, GLP, GCP and GDP Require and How to Stay Compliant What GxP compliance means across GMP, GLP, GCP and GDP, the 2025-2026 updates (ICH E6(R3), EU Annex 11 and 22, DSCSA) and a compliance checklist.
- GMP Compliance and GMP Inspections: What FDA Investigators Look For in Drug Facilities How FDA inspects drug and API facilities for GMP compliance: the six-system model, full vs abbreviated inspections, top 2025 citations and a checklist.
- GMP and GxP Software: Validation, Data Integrity and Automation in 2026 What GMP and GxP software must do, how to validate it for FDA and the draft EU Annex 11, data integrity controls, and where automation and AI fit.
- GMP Audits: How to Plan and Run Internal, Supplier and Mock Inspection Audits How to plan and run GMP audits: self-inspections, supplier and CMO audits, and mock FDA inspections, with the six-system scope and a checklist.
- Pharmaceutical Regulatory Compliance in 2026: Obligations, Enforcement Trends and Compliance Software US pharma compliance obligations in 2026, from GMP and safety reporting to advertising and Open Payments, enforcement trends and compliance software.
- Pharmaceutical Quality Assurance: The Quality Unit's Role, Responsibilities and Common Failures What pharmaceutical quality assurance does, the quality unit's duties under 21 CFR 211.22, how QA differs from QC, and why FDA cites QA failures most.
- Pharmaceutical QMS: Building a Pharmaceutical Quality System on ICH Q10, and Choosing QMS Software How to build a pharmaceutical quality system on ICH Q10, what FDA's QMM program measures, and what to look for in pharma quality management software.
- GMP Documentation: Records, ALCOA+ and the Documentation Errors FDA Cites Most What GMP documentation drug makers must keep under 21 CFR 211, ALCOA+ data integrity, the 2025 EU Chapter 4 draft and the documentation errors FDA cites.
- AI in Pharmaceutical Quality: Use Cases, Regulator Expectations and Quality Assessment in 2026 How AI is used in pharmaceutical quality assessment, what FDA's credibility framework, FDA-EMA principles and EU Annex 22 expect, and where humans decide.
- AI Batch Record Review: Faster Release Without Weaker Data Integrity 21 CFR 211.192 is still a top FDA citation. Learn how AI batch record review and review by exception speed release while meeting GMP expectations.
- 21 CFR Part 11 Audit Checklist: Electronic Records and Signatures in 2026 A clause-by-clause 21 CFR Part 11 audit checklist covering controls, audit trails and e-signatures, plus FDA's enforcement discretion and 2026 updates.
- GMP Deviation Investigation Checklist and Template for Pharma QA 21 CFR 211.192 was FDA's #2 drug citation in FY2025. Use this deviation investigation checklist and template to find real root causes, not "human error."
- Batch Release Checklist: Documentation Requirements in the US and EU What QA must confirm before releasing a batch under 21 CFR 211 and EU Annex 16. A practical batch release checklist plus 2026 trends in faster release.
- GMP Change Control Impact Assessment: A Practical Guide for Pharma Assess GMP changes for quality, validation and regulatory impact. Covers 21 CFR 211.100, 314.70 reporting categories, ICH Q10 and Q12, with a template.
- CAPA Root Cause Analysis and Investigations: Methods, Pitfalls and What FDA Expects How to run a CAPA investigation that finds the real root cause: methods like 5 Whys, fishbone and FMEA, the human error trap, and what FDA warning letters reveal.
- Complaint Management Systems and Software for Regulated Companies: Requirements, AI and Selection What complaint management requires in FDA-regulated industries, what complaint handling software should do, how AI can help triage, and a selection checklist.
- Adverse Event Reporting in the US: FDA Requirements for Drugs and Devices in 2026 FDA adverse event reporting explained: device MDR 30-day and 5-day reports, drug 15-day Alert reports, MedWatch forms, eMDR and the new AEMS system.
- Electronic Batch Records (EBR): What They Are, What Regulators Expect and How to Implement Them What an electronic batch record is, what 21 CFR 211 and Part 11 require, how EBR review works, and how to plan an EBR rollout that inspectors accept.
- Batch Manufacturing Records: Required Contents, Structure and Common Errors What a batch manufacturing record must contain under 21 CFR 211 and EU GMP Chapter 4, master vs executed records, and the errors inspectors cite most.
- Batch Release and Batch Disposition: The Process, Who Decides and What Can Go Wrong How batch release works under 21 CFR 211 and EU Annex 16: who decides, the evidence a batch quality assessment needs, disposition options and failures.
- Batch Record Review: A GMP Guide to Reviewing Batch Documentation for Compliance How to review batch records under 21 CFR 211.192, ICH Q7 and EU GMP: who reviews, what to check, deviations and audit trails, and the gaps FDA cites.
- Batch Release Software and Batch Record Review Automation: What to Automate and How to Validate It Buyer's guide to batch release and batch record review software: what to automate, Part 11 and Annex 11 controls, CSA validation and vendor questions.
- AI for Batch Record Review and Batch Release: What It Can Do and Where Humans Must Decide How AI can support batch record review and release, what draft EU Annex 22 and FDA expect, the April 2026 AI warning letter, and where humans must decide.
- Process Validation: The Three Stages, What FDA and EU Expect, and Common Gaps What process validation means under FDA's lifecycle guidance and EU Annex 15, what each stage requires, and the gaps FDA cited in 2026 warning letters.
- Change Control in GMP: Process, Requirements and How to Make It Work How GMP change control works: the steps, what 21 CFR 211, ICH Q10, EU Annex 15 and ISO 13485 require, reporting categories and mistakes inspectors cite.
- Change Impact Assessment: How to Assess a GMP Change Before You Approve It How to assess the impact of a GMP change: what to cover, how ICH Q9(R1) shapes the risk assessment, revalidation and filing decisions, with a template.
- Computer System Validation (CSV) in 2026: From GAMP 5 to FDA's Computer Software Assurance What computer system validation requires under 21 CFR 211.68, Part 11 and EU Annex 11, how GAMP 5 and FDA's 2025 CSA guidance change it, and FDA findings.
- Regulatory Affairs in Life Sciences: What the Function Does and How It Is Changing What regulatory affairs does in pharma and medical devices, its core lifecycle responsibilities, and how eCTD 4.0, eSTAR, EU reform and AI are changing it.
- Supplier Performance Management: Metrics, Scorecards and Reviews for Regulated Manufacturers How pharma and device makers monitor supplier performance: what regulators require, which KPIs matter, how to build a scorecard and when to act.
- Supplier Risk Assessment: Methods, Criteria and Software for Life Sciences How to assess supplier risk in pharma and devices: risk factors, scoring, EU excipient guidelines, FDA's DEG/EG expectations and supplier risk software.
- Supplier Quality Management: Requirements, Process and Software The supplier quality management lifecycle in pharma and devices: 21 CFR 211, ICH Q10, EU GMP and ISO 13485 requirements, FDA citations and SQM software.
- Supplier Evaluation and Qualification: A Step-by-Step Guide for GMP and Medical Devices A step-by-step supplier evaluation and qualification process for pharma and device makers: criteria, evidence, approval, requalification and FDA findings.
- Supplier Compliance and Document Review: What to Check and How Often What supplier compliance means in pharma and devices, which supplier documents to review, how to verify certificates of analysis and keep files current.
Subjects covered
- pharmaceutical quality management
- pharmaceutical quality assurance
- pharmaceutical compliance
- pharmaceutical QMS
- pharmaceutical manufacturing
- GMP
- GMP compliance
- GMP audit
- GMP inspection
- GMP documentation
- GMP software
- GMP quality management