Uncategorized

Determination of Expiry Date in Pharma Oral Dosage Forms

by

Determination of Expiry Date in Pharma Oral Dosage Forms: Stability, ICH Guidelines & Shelf-Life Calculation (2026 Guide) Quick Summary: Expiry date of oral dosage forms (tablets, capsules, syrups) is determined by stability studies per ICH Q1A(R2). Shelf-life is assigned based on real-time long-term data where the drug remains within 90-110% assay, no significant change in … Read more

Handling of Rejects During Packing in Pharma

by

Handling of Rejects During Packing in Pharma: GMP Compliance Guide for Oral Solid Dosage Forms By PharmaShare | Last Updated: August 2026 In pharma packing, “reject” doesn’t mean “waste”. Every rejected blister, bottle, or tablet is data. It tells you what went wrong on your line. If rejects are not handled properly, you risk: mix-ups, … Read more

Serial number in ‘Reserve’ Status Complaints in Pharma

by

Serial Number in “Reserve” Status Complaints in Pharma: Complete Guide 2026 By PharmaShare Team | Last Updated: August 2, 2026 | Category: Serialization, Track & Trace, DSCSA, GMP One of the most common customer complaints and regulatory observations in serialization today is: “Serial Number is in Reserve Status”. For US DSCSA, EU FMD, India DAVA, … Read more

Handling of Control Samples in Pharma

by

Handling of Control Samples in Pharma: Complete GMP Guide 2026 In pharmaceutical manufacturing, Control Samples and Retention Samples act as legal proof of what was released to market. If there’s a complaint, recall, or regulatory audit after 2 years, these are the samples that save you. This blog covers WHO, USFDA, EU GMP Annex 19, … Read more

CERTIFICATE OF SUITABILITY (CEP)

by

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 483 FORM AND FDA INSPECTION SYSTEM

by

FDA 483 Form & FDA Inspection System: Complete Guide for Pharma Professionals If you work in pharma QA, “FDA 483” is the most feared 1-page form. It’s not a penalty. But if you ignore it, it becomes a Warning Letter, Import Alert, or plant ban. This guide explains what FDA Form 483 is, how FDA … Read more

Generic vs Brand-Name Drugs:

by

Generic vs Brand-Name Drugs: Same Medicine, Different Price? Walk into any pharmacy and you’ll see two versions of the same drug on the shelf. One says “Paracetamol 500mg – Brand X” and costs ₹30. The other says “Paracetamol 500mg – Generic” and costs ₹3. Patients always ask the same question: “If the price is so … Read more

Different types of Patents

by

The Orange Book lists the following as Patents: The active substances or compounds are claimed in patents. Patents on drug products, including formulation-composition patents. Utilize patents for a certain authorized use or indication of the product. The Bolar amendment to the Drug Price Competition and Patent Term Restoration Act permits a pharmaceutical manufacturer (sponsor) to … Read more