GMP & GxP Compliance

CGMP, GxP and the wider regulatory requirements pharma and device manufacturers operate under.

Revised Schedule M vs US CGMP cover: 13 Parts in the rule, 2,574 Indian facilities in the Atlas FDA record, and 14% of Indian drug quality inspections classified OAI against 19% in the US.

Schedule M (India GMP) vs US CGMP: the revised rule, clause by clause, with FDA data from India

What revised Schedule M of India's Drugs Rules, 1945 requires, read from Gazette notification G.S.R. 922(E) and its later amendments: the 13 Parts, the turnover-based deadlines and the December 31, 2025 extension for small and medium manufacturers. The rule is set clause by clause against 21 CFR Part 211, then against FDA's record at Indian drug facilities: 257 drug quality inspections from January 2025 to October 2026, their NAI, VAI and OAI split, and the Part 211 sections cited most.

ICH guidelines cover: all Q1 to Q14 quality guidelines in one table, with ICH Q10 quality unit duties cited on 45.5% of 774 FDA drug inspections citing 21 CFR Part 211, January 2025 to September 2026.

GMP & GxP Compliance

ICH guidelines: the Q1 to Q14 list and what FDA cites under them

What the ICH guidelines are, the full list of ICH quality guidelines Q1 to Q14 with the current version of each, how an ICH guideline becomes FDA guidance, what ICH Q7, Q8, Q9 and Q10 cover, and which ICH concepts FDA investigators enforce through 21 CFR Part 211 citations, from 774 drug inspections in the Atlas Form 483 citation dataset, January 2025 to September 2026.

21 CFR Part 211 cover: all 11 subparts mapped to how often FDA cites each on 779 human drug Form 483s, January 2025 to July 2026

GMP & GxP Compliance

21 CFR Part 211: the 11 subparts and what FDA cites under each

What 21 CFR Part 211 is, who it applies to, the 11 subparts and 60 sections, how Part 210 differs from Part 211, and how often FDA investigators cite each subpart on human drug Form 483s, from 779 forms issued January 2025 to July 2026 in the Atlas Form 483 directory.

What Is CGMP?

Atlas

GMP & GxP Compliance

What Is CGMP? FDA Current Good Manufacturing Practice Explained

CGMP stands for Current Good Manufacturing Practice, the FDA regulations that set minimum requirements for the methods, facilities and controls used to make regulated products. This guide covers why the "C" matters, GMP vs CGMP, which CFR part applies to each product type, the 11 subparts of 21 CFR 211, the sections FDA cited most on 2026 drug Form 483s, and what follows a CGMP violation.

Environmental Compliance for Pharma.

Atlas

GMP & GxP Compliance

Environmental Regulatory Compliance for Pharmaceuticals and FDA

In an industry known for medical innovation, the pharmaceutical sector also faces growing scrutiny over its environmental impact and compliance...

GxP Essentials for QA Teams.

Atlas

GMP & GxP Compliance

GxP Compliance: A Practical Guide for Pharma and Medical Device Teams

GxP covers the full spectrum of Good Practices, from manufacturing to pharmacovigilance. This guide explains the key components, compliance challenges, and how modern tools help pharma and medical device quality teams stay audit-ready.

Pharmaceutical Regulatory Compliance

Atlas

GMP & GxP Compliance

Pharmaceutical regulatory compliance: regulators, requirements and the cost of falling short

Pharmaceutical regulatory compliance means meeting the legal and quality rules that govern a drug from laboratory study to post-market safety reporting. This guide lists the main regulators and the rulebook each one enforces, maps the GLP, GCP, GMP, GDP and GVP stages, sets out what happens when a company falls short, from a Form 483 to a consent decree or a complete response letter, and shows which 21 CFR Part 211 sections FDA investigators cited most on human drug Form 483s from January 2025 to July 2026.