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Pharmaceutical Guideline

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36 articles

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Understanding the 2026 EU Pharma Legislation Overhaul: Key Insights for Compliance Teams

The European Union is preparing for the most significant change in pharmaceutical regulation in over 20 years. On December 11, 2025, political agreement was reached on a new set of rules that will reshape how medicines for human use are developed, approved, and monitored across the EU. The final texts of a new regulation and directive were published in March 2026, marking a major overhaul of the EU pharma legislation framework.This update affects every stage of a medicine’s lifecycle, from early

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Deadline Dilemma: The Case for Extending Revised Schedule M to December 2026

As of January 2026, the Indian pharma sector faces a massive bottleneck: over 13,000 plants require inspection, yet only ~1,100 field inspectors are active. While the government has enforced Revised Schedule M, Laghu Udhyog Bharti is pushing for a vital extension until December 2026 to prevent the closure of thousands of MSMEs and ensure the continued supply of affordable medicine.

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Essential 10 Steps for Good Manufacturing Practice in Pharmaceutical Industry

In the pharmaceutical industry, maintaining Good Manufacturing Practices (GMP) compliance is vital to ensure the safety, quality, and efficacy of pharmaceutical products. Pharmaceutical manufacturers adhere to strict guidelines to meet regulatory standards and guarantee the integrity of their operations. Let

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Emulsions

An emulsion is a dispersed colloidal system consisting of two immiscible liquid phases generally stabilized with one or more suitable agents

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Pure Steam

Pure Steam— is also sometimes referred to as “clean steam”. It is used where the steam or its condensate would directly contact official articles or

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Water for Hemodialysis

Water for Hemodialysis is used for hemodialysis applications, primarily the dilution of hemodialysis concentrate solutions.

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Water for Injection

WFI is used as an excipient in the production of parenteral and other preparations where product endotoxin content must be controlled

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Purified Water Monograph

Purified Water Note—For microbiological guidance, see USP general information chapter Water for Pharmaceutical Purposes 1231. H2O 18.02 DEFINITION

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Purified Water [PW]

PW is used as an excipient in the production of nonparenteral preparations & in other pharma applications, such as cleaning of equipment.

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Policy Regarding N-acetyl-L-cysteine

Guidance for Industry: Policy Regarding N-acetyl-L-cysteine, The New Guidance Document by USFDA (United States Food and Drug Administration)

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VALIDATION MASTER PLAN (VMP)

VALIDATION MASTER PLAN 1. Principle 1.1. Validation in general requires a meticulous preparation and careful planning of the various steps in the process.

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SOPs in Pharmaceuticals: Format, Structure & Writing Guide

Standard operating procedures (SOPs) are the detailed written instructions that specify how a test or administrative procedure is to be performed, or how a piece of equipment is operated, maintained and calibrated. SOPs describe the \"standard\" approved procedures that are routinely carried out in a GMP facility. They indicate exactly how things are done and are kept current by review and approved revision on a predetermined schedule

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Site Master File (SMF): WHO Format, Contents & Example

In this article, we will discuss a practical approach to prepare the Site Master File (SMF) for the Pharmaceutical Industry. We have to understand that The SMF is the document which explains your organization; it creates the image of the organization, So it should be self-explanatory as in most of the case you are not present to explain the SMF.Do you believe that the SMF is creating the first impression of your organization before visiting your Site…After discussing with various regulatory auth

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Happy New year 2021

Pharmaceutical Guideline Wishing Happy New year to you and your family

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JOB in Pharma

Pharmaceutical Industry contributes to improving the health and wellbeing of society.