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The need to build Quality management systems, apart from legal necessity (in the particular case of the pharmaceutical industry), is the story of four people - EVERYONE, SOMEBODY, and NOBODY.
An important project had to be prepared and EVERYONE was asked to do it. EVERYONE assumed SOMEONE else would do it... Theoretically, ANYONE could have done it, but NOBODY did. EVERYONE thought that SOMEONE else should do it, but NOBODY realized that not EVERYONE would do it.
Finally, EVERYONE blamed SOMEONE for helping NOBODY and SOMEONE wisely concluded that NOBODY was the most useful employee in the organization.
If you want a job done right make that NOBODY responsible!
In the field of development, production, and marketing of medicinal products, EVERYONE is responsible for ensuring that at the end of the chain, only quality, effective, and safe medicines end up in the hands of the patient and that they are used rationally.