# GMP: understand and master Good Manufacturing Practices.

Sterile Annex 1, data integrity, deviation management and CAPA: a clear entry point on the requirements that shape pharmaceutical quality — and on how to train your teams on them.

![Illustration of a modern, sterile pharmaceutical manufacturing environment](/assets/img/ressources-bpf-gmp/hero-bonnes-pratiques-fabrication.webp)

## What is GMP?

**Good Manufacturing Practices** (GMP) are the set of requirements that ensure a medicinal product is consistently produced and controlled in line with the quality standards appropriate to its intended use. They cover the entire cycle: facilities and equipment, personnel and training, production, quality control, documentation and traceability.

At the heart of GMP lies a simple but demanding principle: **everything must be documented, and every employee must be trained for their activities.** It is an obligation, not an option — and that is precisely where the gap opens up between an organization that is audited with confidence and one that merely endures its inspections.

Three topics concentrate inspectors' attention today: the manufacture of sterile products (Annex 1), data integrity, and the rigor of deviation handling and CAPA. We detail them below.

100%

of employees must be trained for their activities — a GMP requirement, not an option.

Source: 21 CFR 211.25 (eCFR)

## Three pillars to master.

The GMP topics that most engage your quality and production teams.

Annex 1

### Sterile manufacturing

The revision of Annex 1 has strengthened the requirements on the contamination control strategy, area qualification and operator behavior in the cleanroom. Critical gestures become the core of compliance.

Data integrity

### Data integrity

The ALCOA+ principle (Attributable, Legible, Contemporaneous, Original, Accurate…) shapes inspectors' expectations. Every piece of data produced must be reliable, traceable and tamper-proof, from paper to computerized systems.

Deviations · CAPA

### Deviations & CAPA

Detect, qualify and handle deviations, then put in place effective corrective and preventive actions: a mature CAPA system is one of the first signals of quality maturity examined during an inspection.

## Ready-to-deploy learning paths.

Turn these requirements into skills mastered at the workstation, with our micro-learning modules.

[Training

### GMP training

Clear modules on Good Manufacturing Practices, understandable on the first read and able to stand up to inspectors.

See GMP modules →](/en/academy/gmp/) [Training

### Pharmaceutical quality

Data integrity, deviations, CAPA, pharmaceutical quality system: the paths that secure your day-to-day compliance.

See quality modules →](/en/academy/pharma-quality/)

## GMP: your questions.

What is the difference between GMP and cGMP? +

None in substance: "cGMP" (current Good Manufacturing Practices) is the term used by the FDA to stress that practices must reflect up-to-date technologies and standards. Both refer to the same body of regulatory requirements applicable to the manufacture of medicinal products.

Who must be trained in GMP? +

Everyone involved in the manufacture and control of products, in proportion to their activities. The regulation requires that 100% of people be trained and that this training be traced and assessed.

What is a CAPA? +

A CAPA (Corrective Action / Preventive Action) brings together corrective actions, which address the cause of an observed deviation, and preventive actions, which stop a similar deviation from recurring. The quality of the CAPA system is a key maturity indicator examined during an inspection.

What did the revision of Annex 1 change? +

The revision of Annex 1 placed contamination control at the center, with the requirement for an overall strategy (CCS) and heightened expectations on qualification, environmental monitoring and operator gestures in sterile areas.

## Turn your GMP requirements into mastered skills.

Let's talk about your quality challenges and training your teams.