GxP compliance

GxP compliance means following the "good practice" rules that drug regulators set for the lab tests, clinical trials and manufacturing of every medicine. The x stands for the area: good laboratory practice (GLP), good clinical practice (GCP) and good manufacturing practice (GMP). All of these rules make the same demand. Every step must be recorded, signed and kept, so that a regulator can check it years later.

Here is how it works in general. A person does a step, such as testing a sample or weighing an ingredient. The result is recorded at that moment, with the name of the person who did it and the time. The person signs it. If someone later corrects a value, the old value is not erased. The change, the name of the person who made it and the reason are added to a list called the audit trail. The records are kept for many years, and inspectors from the regulator visit and ask to see them. A common summary of what a good record must be is ALCOA: attributable to a person, legible, recorded at the time, original and accurate.

Most of these records are now electronic. Rules such as America's 21 CFR Part 11 say when an electronic record and an electronic signature can replace paper and ink. The software itself must also be tested and proven to work as intended. This is called computer system validation. In India, the Central Drugs Standard Control Organisation (CDSCO) enforces the manufacturing rules, which are called Schedule M. Indian plants that export medicines are also inspected by the American and European regulators.

Take, for example, a quality-control lab that tests a tablet. Its chromatography data system stores every result, and every time an analyst ran a test again. So a failed result cannot be quietly deleted and replaced.

Consider a clinical trial at a hospital. A nurse types each patient's readings into electronic data capture, and any later correction shows who changed it and why.

Say a plant makes a batch of cough syrup. Its electronic batch record holds each weighing, each mixing time and each operator's signature. The batch is released only after a person in the quality team has reviewed that record.

How is GxP different from a general quality certificate such as ISO 9001? A company's quality management system for ISO 9001 shows that its processes are sound, and the company chooses to be certified. GxP is required by law for medicines, and inspectors check it record by record, down to a single changed number.