Ershad Moradi, Author at Pharmuni

Annual Product Review (APR) in Pharma in 2026: GMP Requirements, Steps, and Checklist

March 26, 2026

The Annual Product Review (APR) is a vital component in pharmaceutical quality systems, reviewing yearly product data to ensure compliance and identify improvement opportunities. It reinforces audit readiness by providing transparent, trend-based insights that drive continuous quality assurance and risk mitigation, ultimately safeguarding patient safety and regulatory compliance.

Audit Trail Review: Complete Guide to GMP Requirements, SOP Steps, and Inspection Readiness in 2026

March 25, 2026

Audit Trail Review is a critical process in pharmaceutical manufacturing that involves examining electronic records to ensure all entries, changes, and deletions are accurately documented and traceable. This review maintains data integrity, prevents errors, and detects unauthorized activities.

Release for Distribution in Pharma Manufacturing: a 2026 Guide on GMP Controls, Roles, and Required Documents

March 24, 2026

Release for Distribution requires Quality Unit authorization confirming all specifications met per WHO GDP Chapter 8, alongside logistics verification of temperature control, documentation, and shipping readiness before patient delivery. This dual authorization ensures regulatory compliance and product integrity throughout the supply chain. Understanding these processes prevents delays and protects patient safety by maintaining GMP standards and traceability requirements.

NDA Regulatory Affairs in 2026: Key Processes, Documents, and RA Responsibilities

March 13, 2026

NDA regulatory affairs work turns science into a review-ready submission. An NDA is the formal FDA marketing application for a new drug. FDA first runs a filing check within 60 days to confirm completeness. Then the team reviews the dossier. The CTD’s five-module structure, delivered through eCTD, improves consistency, traceability, and lifecycle management during review.

Sampling Plan in Pharma: GMP, FDA/EMA Expectations, and QC Workflow

March 13, 2026

A pharmaceutical sampling plan ensures that tested samples truly represent the entire batch. Because results determine product release, regulators require representative collection, justified sample size, controlled handling, and full documentation. Strong sampling practices reduce risk, support compliance, and protect patient safety.

GMP Packaging in 2026: Requirements, Guidelines, Controls, and Primary vs Secondary Packaging

March 12, 2026

GMP packaging protects product identity, quality, and traceability while preventing mix-ups and labeling errors. Strong controls such as line clearance, reconciliation, and component management ensure only correct, compliant products reach patients and markets.

Visual Inspection in Pharma (2026): What It Is, Scope, PDF Guides and SOP Essentials

February 27, 2026

Visual Inspection checks parenteral units for particles, damage, and labeling errors before release. EU GMP Annex 1 expects inspection of parenteral containers (8.30) and warns visual inspection cannot replace integrity testing, including 100% testing for fusion-sealed volumes ≤100 mL (8.22).

Quality Oversight In 2026: Roles in pharma industry, GMP Expectations, And Risk-Based Control

February 26, 2026

Quality Oversight keeps GMP decisions consistent, traceable, and risk-based. It connects deviation handling, CAPA, change control, and trend reviews. It also proves management engagement through documented actions. Strong oversight reduces repeat failures and supports confident batch disposition.

Revalidation In Pharma (2026 guide): Meaning, Triggers, Frequency, And Requalification Differences

February 25, 2026

Revalidation protects product quality and business continuity by linking GMP decisions to risk, evidence, and context. This article helps teams decide when to act, what to document, and how to classify issues consistently before audits and regulatory inspections.

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