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QA approval of SOPs

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  • Steve
    21/05/2015 17:12
    Hi Everybody, I work in a GLP/GMP contract testing facitilty. We try to adhere to the highest standard when it comes to GLP and GMP regs. My question surrounds SOP approval. GLP says that QA does not approve SOPs. GMP says they do approve SOPs. What is the highest standard here? Would it be safe to have 2 approvers: QA and lab management. Has anyone encountered this? Thank you!
  • Adrian
    11/06/2015 16:56
    Two or more... We have Author, Technical Approval and QA Approval. The QA approval is the publication of the document. We check format, style, pagination etc The Technical approval is the laboratory signature that is the most appropriate individual to the content of the SOP. Publish an SOP with whatever is decided and follow that.
  • RQA GLP Committee
    18/06/2015 08:55
    Dear Steve/Adrian, Although GLP does not say that QA should approve SOPs, it does not forbid it either. It is fine to have a signature, but be clear what the signature means - is it an approval or a review? You could say that the relevant SOPs are approved for GMP use, or have a separate mechanism that records the review has been conducted by QA.
  • Rao
    15/06/2020 05:18
    Dear RQA team, I have similar question as i have encountered some problems with approval procedure (i am handling GLP, GMP and GCP QA). Please let me know, QA SOPs should be approved by QA or Management (TFM) has to approve. Regards, Rao
  • RQA GLP Committee
    17/06/2020 09:28
    Dear Rao, In GLP all SOPs should be approved by TFM. QA will be the authors of their own SOPs.
  • GMP Committee response
    29/06/2020 14:09
    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.
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