07.07.2015 |

LOGFILE No. 40/2015 – The purpose of GMP

The purpose of GMP

An excerpt of GMP Fundamentals

by Dr. Christine Oechslein

The purpose of GMP

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Introduction

It can happen to anyone: in the workplace, at home or on the street. One moment you're a health-conscious individual who believes in regular exercise, the next moment you're a patient. Your are quite lucky if it happens to you in Central Europe, because you will more than likely wake up in a well-organised, clean A&E department. With a life-saving infusion solution provided to treat eventual shock, circulatory collapse, organ failure and alleviate pain. A human life hanging on an IV line.

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But what if the content of the infusion bag was not as it should be? And contaminants, bacteria or an incorrect active ingredient were fed directly into a vein in the patient's arm? Can we consumers be absolutely certain that medicinal products are of the highest quality?

Medicinal products are quite different from other products such as foodstuffs.

  • The consumer has no way of determining the quality of a medicinal product, whereas fruit and vegetables can be judged fit for consumption based on their appearance, aroma and taste.
  • You can eat large amounts of fruit, vegetable and other foodstuffs without a thought. Medicinal products, on the other hand, can have an enormous effect even when taken in tiny quantities, and often affect the entire body. Examples include antibiotics, hormones, anti-cancer drugs and medicinal products used to treat cardiovascular problems.

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This means that medicinal products, if incorrectly manufactured and stored, can pose a particular risk for patients. Medicinal products are not always stored correctly, and an internationally recognised standard has not yet been agreed. Fortunately, there are laws in the EU and in many other industrialised countries that regulate the manufacture and distribution of medicinal products in order to protect the consumer against substandard, and ineffective or dangerous medicinal products. The laws, regulations and standards describing the manufacturing process of a medicinal product from raw material to shipping are normally referred to as "Good Manufacturing Practice" or GMP rules, for short.

What is GMP?

GMP stands for Good Manufacturing Practice. GMP rules apply to the manufacture, packaging and testing of medicinal products and must be strictly observed to ensure that only high-quality medicinal products come onto the market.

Why do we need GMP?

Anyone who boards an aircraft must be confident that it was properly serviced, has been fuelled with a sufficient amount of the correct fuel, that the weather conditions along the flight path have been checked, and that the pilots and air traffic controllers are well-trained and concentrate when carrying out their jobs. The safe arrival of the passengers and crew at the destination airport cannot be left to chance. Everything must be carefully planned and checked and rechecked. The passengers have no way of confirming that everything has been carried out properly and cannot take corrective action.

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Medicinal products are no different: it cannot be left to chance whether a patient obtains the right tablets, whether the tablets are contaminated or are spoilt, or whether a package contains different dosages. For this reason, careful planning, proper implementation and systematic monitoring are required.

What was it like before the GMP rules were introduced?

Every time our safety is called into question, e.g. after accidents affecting aircraft, trains or shipping, fires in tunnels or other disasters, people demand stricter regulations, standards and controls to prevent similar incidents in the future. The GMP rules developed in the exact same way. For centuries, healers and pharmacists produced remedies to the best of their knowledge and in good faith. Analytical testing of finished drugs has been carried out since the Middle Ages, as seen in ancient pharmacopoeias (see chapter 3.E.5 ). The degree of care with which the work and testing were carried out was left up to the individual. Nobody was obliged to consider the consequences that their errors might have for their patients (quality risk analysissee chapter 4.C.3 ). As long as drugs were only produced for an individual or a small clientele, only a small number of people were affected when an error did occur. The industrial manufacture of medicinal products brought change because the number of patients grew dramatically. Incidents were inevitable: the history of Good Manufacturing Practice is unfortunately one of disasters...

What can go wrong?

More than one hundred years of industrially manufactured medicinal products has shown that many things can go wrong during manufacture, testing and distribution:

  • contamination caused by poor cleaning of machinery, containers and rooms, by containers that are not properly sealed, and even by ventilation systems that spread dust particles instead of removing them from the air
  • the mixing of two active ingredients or products because rooms or machines were not completely freed of a previous product during a product changeover, or controls were not carried out with due care and attention
  • incorrect active ingredient or incorrect dosage because the identification on containers or machines was illegible or difficult to read, labels were mixed up or fell off and, as a result, mix-ups occurred
  • insufficient active ingredient because the expiry data was incorrectly printed or incorrectly entered in the computer system
  • insufficiently sterilised infusions because the sterilisers were not properly serviced and maintained
  • decomposed and thus ineffective active ingredient due to storage under incorrect conditions
  • bacteria in ampoules for injection because they were shipped in unsuitable transport boxes, leading to hairline cracking
  • counterfeiters placing inferior medicinal products earmarked for disposal on the market because they were not disposed of safely

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Figure 1.E-1: Medicinal products are special products

Legislators in the affected countries have responded to all of these incidents. GMP rules are, therefore, responses to a number of incidents.

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Author:

Dr. Christine Oechslein 
GMP Instructor, Germany

The text is an excerpt from our brand new hand book GMP Fundamentals:

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A Step-by-Step Guide
from Beginner to Advanced Level and Beyond

 

 
 
 

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