Pharmaceutical GuidelineLearning is lifeEmpowering Excellence in Pharmaceutical Manufacturing
admin@pharmaceuticalguideline.com22 articles tagged “FDA”
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.
The list of titles of the Code of Federal Regulations The 21 CFR is the Title 21 for Food and Drugs
Draft guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
Deaerated Water or “degassed water” is Purified Water that has been treated to reduce the content of dissolved air by “suitable means” ...
GUIDANCE DOCUMENT Multiple Endpoints in Clinical Trials Guidance for Industry OCTOBER 2022 Docket Number: FDA-2016-D-4460 Issued by: Center for Biologics…
US FDA has revised the guideline for Size, Shape, and other physical Attributes of Generic Tablets and capsules. USFDA Guidelines
Water for Hemodialysis is used for hemodialysis applications, primarily the dilution of hemodialysis concentrate solutions.
User Requirements Specification (URS) is An authorized document that defines the User requirement in Pharmaceutical Industry
Guidance for Industry: Policy Regarding N-acetyl-L-cysteine, The New Guidance Document by USFDA (United States Food and Drug Administration)
Update on New Guideline; by USFDA Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format…
Good Chromatography Practices for the pharmaceutical industry
USP-43 〈1151〉 Films PHARMACEUTICAL DOSAGE FORMS
Capsules PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43, Chapter <1151>
Aerosols PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43
〈1151〉 PHARMACEUTICAL DOSAGE FORMS This article is based on the requirement of the United State Pharmacopoeia.
Working document QAS/21.875, February 2021. World Health Organization (WHO) has published the DRAFT WORKING DOCUMENT FOR COMMENTS.
INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS)—PRODUCT QUALITY TESTS This article is based on the requirement of the United State Pharmacopoeia…
Co-operation Scheme (PIC/S) has revised the guidance document for INSPECTION OF UTILITIES on 19 January 2021
Co-operation Scheme (PIC/S) has revised the guidance document for GMP INSPECTION RELATED TO PAC on 19 January 2021
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
In this article, we will learn about Quality Policy In the pharmaceutical industry Quality Policy is classified as a level-1 document Importance…
Pharmaceutical Industry contributes to improving the health and wellbeing of society.
