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
SUPAC Guidance for Pharmaceutical Industry – Complete FDA Guide to Scale-Up and Post-Approval Changes SUPAC Guidance: A Complete Guide to Scale-Up and Post-Approval Changes in the Pharmaceutical Industry The pharmaceutical industry operates under one of the most stringent regulatory frameworks in the world. After receiving FDA approval, manufacturers often need to make changes to formulations, … Read more
Variation Filing in Europe: A Complete Guide for Pharmaceutical Regulatory Professionals Variation Filing in Europe – Complete Regulatory Guide Once a medicinal product receives marketing authorization in the European Union (EU), its lifecycle does not end. Pharmaceutical companies frequently implement changes to manufacturing processes, analytical methods, packaging materials, manufacturing sites, quality controls, safety information, and … Read more
Types of Variation Filing in USA for Pharma: PAS, CBE-30, CBE-0 & Annual Report | Pharmashare Types of Variation Filing in USA for Pharma: PAS, CBE-30, CBE-0 & Annual Report Explained Last Updated: April 2026 | For: Regulatory Affairs, CMC, QA Professionals If you work in Regulatory Affairs for US FDA submissions, you face this … Read more
FDA 483 Observations Related to Inadequate Investigations in Pharmaceutical Manufacturing FDA Form 483 Observations Related to Inadequate Investigations in Pharmaceutical Manufacturing In the pharmaceutical industry, investigations are a critical component of the Quality Management System (QMS). Whether dealing with deviations, out-of-specification (OOS) results, customer complaints, environmental monitoring excursions, or product quality defects, a thorough and … Read more
