GCP Approval of SOPs


I’m currently updating SOPs a company that is active in GCP, GLP en GMP.

Currently the process owner and QA Management approve the SOP, and the Managing Director authorizes the SOP.

Is this really necessary, or could it also be that just the Process Owner and QA Management approve the SOP.

Thanks in advance Erik

Hi @Erikv01,

Have you got a governing document on approvals detailing what level of management should approve what document? If this document states that the MD needs to sign then he will need to sign.

The bigger question I guess is why is he signing…what is the justification and is there value add with his/her signature or are you just ticking a compliance box?

@David1 have you any thoughts on this?


Hi @gokeeffe there is indeed a governing SOP on approvals but I’m questioning the need for the authorization of all SOP’s by the MD as some of my colleagues insist it is required conform the GCP guidelines, but I cant find such a requirement only when it applies to sponsor trials etc.

Regards, Erik

Understood so @David1 will be a better person to answer this as he is the laboratory expert but if a guideline only states this then does is it actually required…is there any actual REGULATION that states this?

Sorry I’m not best positioned to give a definitive answer on this but I’m sure others on here will like @Boomer_Chemist and @JaredCroft

Hi there,

The requirements for approving GCP documents should be defined in the quality management system (QMS). Everyone who are required to approve the document, as defined in the QMS, should be included in the document.

It is important to have a clear understanding of the meaning of each signature. This again should be defined in the QMS.

If someone is approving a document they should understand it and be able to explain its contents.

Generally a document should be signed off by:

Reviewer, this is a technical review to ensure the document is technically correct
Approver, This should be done by the heads of all departments affected by the document and should ensure the document is acceptable to the respective department.
Authorised by the quality assurance department. This is to assure that the document complies with all regulatory and company requirements.

It is important that all documents are signed off in a consistent manner as any inconsistencies can attract audit observations.

Dr David Trew
BSc (Hons), PhD, CChem MRSC

David Trew Consulting Ltd
Consultancy services for chemistry based businesses
and laboratory service sectors.

There is no regulation requiring the MD (head of company) to sign off on SOPs. In a GLP environment (non-clinical testing on chemical substances) there are specific requirements for the study director to sign certain documents related to studies. But this does not extend to SOPs which can apply to multiple studies.

Which regulation or guideline are your colleagues referring to? Generally the regulations/guidelines do not provide instructions at that level. They typically specify that a company shall have policies that specify who should sign off documents. They do not specify what those policies should be, that is left to the companies to decide for themselves.

Dr David Trew
BSc (Hons), PhD, CChem MRSC

David Trew Consulting Ltd
Consultancy services for chemistry based businesses
and laboratory service sectors.

I think there are three minimum signatures required on all documents.

Author approval
Technical reviewer/system owner (this may be your MD, but it may be someone else more technically attune to that peice of equipment).
Quality reviewer (QA).

The higher level of documentation (master plans, documentation practices, company policies) should be approved by higher level personnel. While lower level documentation (operation of autoclave or HPLC) probably are more technical than your MD’s expertise (at least at this point in his/her career).

Perhaps you could set up various types of documents, for various levels. That way it is clear what level each document is on, and who the reviewers should be.

NOTE: There may be more than 3 reviewers, depending on the document. For example a lab practice which involves a hazardous chemical, or a safety practice might also require EH&S approval.

Overall, QA is the final authority on if the correct people are on the signature list. This is one quality system which is governed by QA.

Normally it is QA that finally signs the SOP, since they are responsible for the SOP system including updates. The Process Owner proposes these new updates. The Managing Director reviews the SOP (including updates) and implements them (otherwise why be a director if you can’t direct).

In my experience the Managing Director is not required to sign as the technical expert. This can easily be delegated (also the role of a director) to people. I imagine the level of delegation is based on the size of the company and responsibilities of the managing director (as he/she see’s fit). It sounds like the original poster was asking if the MD signature is required. The answer is no, but it is possible for the MD to sign each SOP as a reviewer if the MD feels like his/her signature is required, otherwise the director can delegate to another suitable technical expert. I think this decision will be made by the MD him/herself.

Thank you everybody for your replies, I have discussed it with the Quality Director, its indeed been decided that the MD doesnt need to sign the SOPs anymore.

Nice result @Erikv01 it makes me very happy when community discussions have an outcome like this. :smile: