Hetero Analytical Blog - Analytical Testing Laboratory in Ahmedabad

In pharmaceutical analytical testing, instrument calibration in pharma is not a routine formality — it is a regulatory requirement . Even when test methods are validated and analysts are skilled, poor or incorrect calibration can make results unacceptable to regulators . Regulatory agencies such as the FDA, EMA, WHO, and CDSCO  expect every analytical result to be generated using properly calibrated instruments . If calibration records are weak, missing, or outdated, the enti

Why Certificate of Analysis (COA) Errors Pharma Lead to Export Shipment Rejections For pharmaceutical exporters, a Certificate of Analysis (COA) error pharma  is more than a document — it is a passport for global market entry . Even when a product meets all quality specifications, a single COA error can result in shipment holds, rejections, or regulatory scrutiny . In today’s regulatory environment, authorities such as FDA, EMA, WHO, and importing country regulators  carefull

Inaccurate Stability Data:- In pharmaceutical manufacturing, shelf life is not an assumption — it is a regulatory claim backed by stability data. When that data is inaccurate, incomplete, or poorly documented, regulators don’t hesitate to reject shelf-life claims. In recent years, authorities like FDA, EMA, WHO, and CDSCO  have tightened scrutiny on stability studies. Many product approvals are delayed or rejected not because the product is unstable, but because the stabilit

Pharma Batch Failure : In pharmaceutical manufacturing, batch failure during regulatory testing is one of the most expensive and frustrating outcomes. A single failed batch can lead to retesting, delayed approvals, export rejections, or even product recalls. Regulatory agencies such as the FDA, EMA, WHO, and CDSCO  expect strict adherence to analytical accuracy, data integrity, and documented compliance. Yet, pharma batch failure occur due to avoidable mistakes. Here are the

Outsourcing Pharma Testing Pharmaceutical manufacturing is evolving faster than ever. With rising regulatory expectations, global competition, and the need for flawless documentation, companies are rethinking how they manage analytical testing. 2025 marks a notable shift: outsourcing pharma testing: Pharma companies are outsourcing more testing activities to accredited laboratories than ever before. But what’s driving this change? And why is outsourcing becoming the smarter,

Introduction to Analytical Testing Errors In the world of pharmaceuticals, analytical testing  is the backbone of every regulatory submission. Whether it’s an ANDA, NDA, DMF, or export dossier, your testing data determines whether your product reaches the global market — or gets rejected. And here’s the truth: Most FDA/EMA rejections are not because the product fails… but because the testing  fails. From data integrity lapses to incomplete validation, small analytical mistake

Pharma Audits 2025 Introduction: Pharmaceutical companies face a growing wave of unannounced audits  and stricter global regulations. From the USFDA and EMA  to CDSCO and WHO , every authority now expects not just compliance—but continuous inspection readiness . In 2025, being “audit-ready” means maintaining real-time control, transparent data, and validated systems —not scrambling when an inspection notice arrives. Why Audit Readiness Matters Audit readiness is no longer a

Meeting pharma export quality standards is critical to accessing global markets. Learn how GMP, ISO, and ICH compliance build trust, prevent rejections, and drive export growth.

Pharma Stability Testing : Stability testing is one of the most critical steps in pharmaceutical development. It ensures that drugs...

Discover why outsourcing pharma stability testing saves time, money, and regulatory risk. Learn the cost of failures vs. benefits of outsourcing to NABL-accredited labs.

Why Data Integrity Is More Than a Checkbox — It’s Your Client’s Trust Introduction In the pharmaceutical world, passing analytical tests...