DSCSA in Pharma – Complete Guide to the Drug Supply Chain Security Act (2026) DSCSA in Pharma – Complete Guide to the Drug Supply Chain Security Act (2026) Counterfeit medicines, diverted products, stolen drugs, and illegitimate pharmaceuticals pose serious risks to patient safety worldwide. To strengthen the integrity of the pharmaceutical supply chain in the … Read more
What is RFAR in Europe? RFAR stands for Rapid Field Alert Report. In EU terminology it’s directly linked to FSCA – Field Safety Corrective Action for medicinal products. Definition: An urgent communication to Competent Authorities and customers regarding actions taken to reduce risk of a defective medicinal product already on the market. Key EU Regulations … Read more
Field Alert Reports (FAR) in Pharma: FDA Requirements, Submission Process & Compliance Guide 2026 Field Alert Reports (FAR) in the Pharmaceutical Industry: Complete FDA Compliance Guide In the pharmaceutical industry, maintaining product quality after commercial distribution is one of the most critical responsibilities of drug manufacturers. Despite robust quality systems and validated manufacturing processes, unexpected … Read more
APQR in Pharma: Complete Guide to Annual Product Quality Review (2026) APQR in Pharma: Complete Guide to Annual Product Quality Review Annual Product Quality Review (APQR) is one of the most critical Quality Management System (QMS) activities performed by pharmaceutical manufacturers. It provides a structured annual evaluation of manufacturing performance, analytical trends, product quality, process … Read more
CEP Certificate: EDQM Drug Substance Dossier Guide 2026 | PharmaShare CEP – Certificate of Suitability to the Monographs of the European Pharmacopoeia: Complete Guide 2026 Last Updated: January 15, 2026 | Reading Time: 12 mins Filing for EU market authorization? If your drug product uses an active pharmaceutical ingredient, you’ll face this question: “CEP or … Read more
FDA and Global Regulatory Inspection Expectations for CPV Regulatory authorities expect Continued Process Verification (CPV) to be an integral part of the Pharmaceutical Quality System (PQS). During inspections, investigators typically evaluate whether manufacturers have established a scientifically justified and risk-based program to continuously monitor commercial manufacturing processes. Inspectors commonly review: Documented CPV procedures and responsibilities … Read more
Statistical Tools Used in Continued Process Verification (CPV) A robust Continued Process Verification (CPV) program relies heavily on statistical methods to identify trends, monitor variability, and detect process shifts before they affect product quality. Modern pharmaceutical manufacturers utilize statistical software and data visualization tools to evaluate process performance in real time. 1. Statistical Process Control … Read more
Continued Process Verification (CPV) in Pharmaceuticals – Complete Regulatory Guide Continued Process Verification (CPV) in Pharmaceuticals – Complete Regulatory Guide The pharmaceutical industry has evolved significantly from traditional process validation approaches toward a lifecycle-based validation philosophy. One of the most important elements of this lifecycle approach is Continued Process Verification (CPV), which ensures that manufacturing … Read more
Marketing Authorization Approval Process in Europe | Complete Guide to EU Pharmaceutical Registration Marketing Authorization Approval Process in Europe: Complete Regulatory Guide Obtaining a Marketing Authorization (MA) is one of the most important milestones in bringing a pharmaceutical product to the European market. Before any medicinal product can be marketed within the European Union (EU) … Read more
Blister Missing Complaints in Pharmaceuticals: Root Causes, Investigation & Remedial Actions Blister Missing Complaints in Pharmaceutical Manufacturing: Root Causes, Investigation and Remedial Actions Blister packaging is one of the most widely used packaging systems in the pharmaceutical industry because it provides excellent product protection, enhances patient compliance, and allows easy visual inspection of tablets and … Read more
