Standards

Pharmacopoeia and international standards (USP/EP/ICH/ISO/WHO).

21 CFR Part 210/211 — US GMP Regulation Structure Overview

How 21 CFR Parts 210 and 211 are organized and what each subpart addresses.

EU GMP Annex 1 — 2022 Revision Key Changes for Sterile Manufacturing

The most significant changes introduced by the 2022 revision of EU GMP Annex 1.

ICH Guidelines — Overview of Quality (Q), Safety (S), Efficacy (E) Series

A map of the ICH Q/S/E guideline series and how they fit together across the product lifecycle.

ISO 13485 — Quality Management for Medical Devices Overview

What ISO 13485 requires of a medical device quality management system.

ISO 14644 — Cleanroom Classification Standard Overview

What the ISO 14644 series covers beyond classification, including monitoring and testing.

ISO 15378 — Primary Packaging Materials Quality Management

What ISO 15378 adds on top of ISO 9001 for primary packaging material manufacturers.

ISO 9001 — Quality Management System Requirements for Pharma Suppliers

What ISO 9001 certification means for a pharmaceutical supply chain vendor, and its limits.

Pharmacopeial Harmonization — USP/EP/JP Convergence Status

How the USP-EP-JP harmonization process works and where meaningful differences still remain.

USP-NF — Structure and How to Navigate Monographs

How the USP-NF is organized and how to read a monograph to find the requirements that matter.

WHO GMP Guidelines — Comparison with EU/FDA GMP Requirements

Where WHO GMP guidance aligns with, and differs from, EU and FDA GMP expectations.