GMP Committee response
The regulatory requirements are not the same for all GxPs… as GMP Committee, we are responding in relation to GMP
In responding to such a question, it is always appropriate to refer to EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines. In this case Chapter 1 Pharmaceutical Quality System. Section 1.3 has the most important words for this response.
“The size and complexity of the company’s activities should be taken into consideration when developing a new Pharmaceutical Quality System or modifying an existing one. The design of the system should incorporate appropriate risk management principles including the use of appropriate tools. While some aspects of the system can be company-wide and others site-specific, the effectiveness of the system is normally demonstrated at the site level.”
SOP are key element in any PQS and their Generation, Review, Approval, dissemination, training and update and retirement etc are a life cycle that Senior Management are required to have in place. Who when and what will change from one organization to another and will have to meet the needs of key internal and external stakeholders (e.g. Clients or Inspectorate). The SOP on SOPs would be a good place to define the answer in the context of the specific company.
In most companies QA becomes the last step in ensuring the company specified lifecycle is adhered to.
For a significant proportion of companies both Management and a separate QA approval on GMP related QA SOPs occurs.