CGMP study guide

CGMP · Work through your exam, one topic at a time.

The CGMP credential (Certified Good Manufacturing Practice, sometimes written cGMP) is a professional certification for people who work in regulated pharmaceutical, biotech, medical device, or dietary supplement manufacturing. Candidates typically hold roles in quality assurance, quality control, production, validation, engineering, or regulatory affairs, and the exam tests whether they can apply current good manufacturing practice principles to real shop-floor and quality-system decisions rather than simply recall definitions. The CGMP study guide has 10 sections and about 5,589 words.

Quality Management System and Quality Oversight

This domain tests whether you can describe the quality system a cGMP site must maintain: the independence and authority of the quality unit, the elements of ICH Q10, management review, quality risk management under ICH Q9, and how deviations, CAPAs, change control and supplier oversight feed back into the system. Questions usually probe who may approve or reject, what evidence proves the system functions, and how signals escalate.

553 words, about 3 min 02

Personnel, Training, and Hygiene

This domain tests the human side of cGMP: how personnel are qualified by education, training and experience; how training is documented and its effectiveness proven; how hygiene, health and gowning protect the product; and how contractors and consultants are controlled. Expect scenario questions in which an untrained or unwell person is placed near product.

567 words, about 3 min 03

Premises, Facilities, and Utilities

This domain tests facility design, segregation, air handling, cleanroom classification, water and gas systems, and the maintenance regimes that keep them in control. It rewards candidates who can read a floor plan in words and identify where contamination or cross-contamination could occur.

579 words, about 3 min 04

Equipment, Qualification, and Calibration

This domain tests equipment design, qualification stages, calibration and maintenance, and the investigation of measurement failures. It rewards candidates who can separate qualification from validation, and calibration from verification.

517 words, about 3 min 05

Documentation, Records, and Data Integrity

This domain tests the record hierarchy, what a batch and laboratory record must contain, how corrections are made, how long records are kept, and how data integrity is protected in electronic and paper systems. Data integrity questions are common and are usually about behaviour, not technology.

577 words, about 3 min 06

Production and Process Controls

This domain tests written production procedures, charge-in and yield controls, in-process controls and time limits, microbiological control, reprocessing, and the process validation lifecycle. Questions often describe an operator improvising a fix and ask what should have happened.

521 words, about 3 min 07

Materials Management, Warehousing, and Supply Chain

This domain tests receipt, sampling and status control of materials, reliance on supplier certificates, storage and stock rotation, retest versus expiry dating, and supply chain integrity including distribution controls. Questions often turn on whether a certificate of analysis can replace testing.

561 words, about 3 min 08

Quality Control, Sampling, and Laboratory Controls

This domain tests the laboratory side of cGMP: specifications and test methods, sampling, out-of-specification investigation, stability programmes, reserve samples and method validation. Most questions are decided by what you may and may not do after an unexpected result.

556 words, about 3 min 09

Validation, Qualification, and Change Control

This domain tests validation types and their regulatory basis, cleaning and computer system validation, and the change control process from request to verified closure. Questions often ask whether a proposed change needs revalidation, requalification or a regulatory filing.

545 words, about 3 min 10

Complaints, Recalls, Deviations, and CAPA

This domain tests how a site detects, investigates and responds to product problems: complaint handling, recall classification and execution, deviation and investigation requirements, and corrective and preventive action through to verified effectiveness. Expect questions where a company takes the cheapest visible action.

613 words, about 3 min