Good Manufacturing Practices (GMPs) were first established in the 1970s with the aim of increasing the safety of drug manufacturing operations. Their beginnings are located in the USA as a result of the identification of several public health problems, which had their origin in quality failures in the manufacture of medicines. Its implementation was progressive in the European Union and it was not until the 1990s that it became widespread and standardised with the creation of the EMA (EMEA at the time) in 1995.
In their first stage, GMPs were formulated only for drug product manufacturing operations. It was not until 10 years later that Active Pharmaceutical Ingredients (APIs) were integrated into the scope of EUGMPs.
Initially, the introduction of GMPs in the pharmaceutical industry meant a major change and highlighted the need to establish effective quality systems (QS) in order to comply with the spirit of GMPs. The reality in many cases was that the existing quality system were not sufficient to address GMP compliance in a harmonious and comprehensive manner. In many cases, the implementation of GMPs was formal and – to a greater or lesser extent – ineffective, creating an inspectable environment that, in many cases, was not faithful to the day-to-day reality. On the other hand, the formulation of the initial GMPs was more oriented to providing a list of requirements than to stimulating self-responsibility in the elimination of risks to the patients’ health.
The initial stage of the EUGMPs was also a break on new technologies and processes, which was considered to be a break on the evolution of the sector to some extent. In this context a reform of the GMPs was initiated. This time, the initiative also started from the USFDA with the project “PHARMACEUTICAL cGMPS FOR THE 21st CENTURY — A RISK-BASED APPROACH” in 2004, which in turn gave input to the work of various International Conference on Harmonisation (ICH) committees in the preparation of ICH Q9 “QUALITY RISK MANAGEMENT” (2005), ICH Q8 “PHARMACEUTICAL DEVELOPMENT” (2005 initially, current version 2009) and ICH Q10 “PHARMACEUTICAL QUALITY SYSTEM” (2008).
The new approach expressed in the ICH guidelines stands out for the following:
· Quality by Design (QbD)
· Quality management through risk management
· Knowledge management through the complete product lifecycle
· Effective pharmaceutical Quality System
As we have seen, GMP have evolved from a simple list of requirements to a completely new cultural approach based on Quality by Design and risk management while taking into account the complete product lifecycle looking for an effective pharmaceutical Quality System.