Good evening all,
I need to look for your experience,
I have question who is DIP approver in your companies?
Example:
Authors: QA, QC, production spec.
Reviewers: QA/QC/Production managers
Approvers: QP, head of GPM.
QA is always the last to approve a protocol or report.
If it is a QA document, and the Head of GMP is approving it, then it might be that they are approving a Quality System SOP.
If this is the case, then your example of authors/reviewer/approvers is suitable.
For other things, (like EH&S safety SOPs), you only need one QA person.
Thank you for answer.
Now in our company all quality documents are approved by quality director.
We want to change this. Validation/qualification documentation send to approving only to head of GMP department, but deviations for head of GMP department and QP.
OK. You’ll need to clarify your statement. Is that sufficient oversight? Is that what you’re asking?
Sorry. Yes, it my general question.
You cannot change it. BMR, Validation, Qualification, SOP and all the QA documents are controlled by the Head of QA, but if you want to make sure your documents are ok, you may take another person as a simple reviewer.
People who make the above mentioned documents, are responsible of their documents.
And there is no GMP Departement and no Head of GMP in a Pharma industry.
Each industry, has its Departments (QA, QC, Production) to comply with the GMP.
In our company - QA department is GMP Assurance Department.
Now - Approver of all documents is quality director. GMP assurance department manager is reviewer.
Not necessary to approve validation/qualification documentation by quality director. Enough for GMP assurance department manager.
And deviations protocols must be approved by QA- GMP assurance department manager and Qualified Person.
QA documents are approved only by the Quality Director. The managers, who are qualified people in pharmaceuticals, are at the same time the reviewers of the documents. If it is necessary to review again the documents, you may take another person.
But, the QA documents are approved only by the QA Director.
We discuses this topic during ECA training.
QA documents is very different. SOPs, deviations protocols, risks…must be approved by quality director and QP.
But, validation /qualification documentation (protocols/reports) not necessary for quality director approving, enough approving of GMP/QA assurance department manager.
No, validation and qualification must also be approved by the Head of Department and Head of Quality Assurance.
Validation is an important document that ensures the process is OK.
How can it be approved only by the Manager?
Usually the ‘Validation Master Plan (VMP)’ specifies who is on the ‘Validation Review Board (VRB)’ and who signs authorizes and signs all validation documents.
If the production is approved by the Head of Production, a QA document should be approved by the Head of QA.
This is logical, too.
Usually the VRB consists of;
QA (quality assurance)
QC (quality control)
Validation
RA (regulatory affairs) or Compliance
Operations or Production
These can be the Site Heads or designates
GMP/QA assurance department manager (not specialist) is the Head of QA, validation and qualification. Therefore it is acceptable for validation protocols/reports.
Dear Tatjana, the Head of QA is only the Technical Director of the company.
If you consider yourself a Head of QA, you should than controll not only
the validation/qualification, but all the QA documents (that are many).
One time you say you are the Head of GMP, the second time the manager and
now the Head of QA.
Dear karajmalvina89,
Different companies have different structures. In our company, as in many others Technical Director is not related to the quality department.
The main thing is that this does not contradict to the internal documentation and GMP requirements.
I finish this discussion,after ECA training the question is no actual.
Good luck.