Abstract
Pharmaceutical industry, in addition to assuming the sanitary commitment, as has been demonstrated with the manufacturing of COVID-19 vaccines, must comply with the European Union Good Manufacturing Practices, for that reason it´s subject to a continuous updating demanded by the regulatory requirements. This commitment is even, if possible, greater for injectable drug’s manufacturing companies due to their intrinsic characteristics of safety for the patient, all this together with the maximum productivity objective.
A review about the main challenges that the pharmaceutical industry must face for the manufacture of injectable products is carried out, that comprised the incorporation of new biological drugs and advanced therapies into the therapeutic arsenal, the increase in terms of the requirements in regulatory and inspection tasks by health authorities and the leading role that Contract Manufacturing Organisations are playing. On the other hand, issues such as the analytical methods used to evaluate product sterility validity, the impact of possible changes in the different processes and elements, especially in the case of aseptic manufacturing, and the evolution, with the implementation of Sterility and Quality by Design, of sterile products manufacturing science are discussed. Finally, the implementation of disruptive factors such as continuous manufacturing and robotization, which will have, with a high probability, a greater role in the not-so-distant future, is proposed.
Key Words: Sterile Drugs, Inspection, Aseptic Manufacturing, Isolators, Good Manufacturing Practices, PAT, Pharmaceutical Industry