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Section: Core Facility
Subject: Standard Operating Procedures / Policies
F. GENERATION OF NEW SOPs
New SOPs are to be generated at the discretion of the facility director. The director will authorize and
oversee the generation of new SOPs based on findings of the Quality Assurance program, or on the
recommendation of the medical directors, the facility manager, the facility quality assurance department,
or on the direction of the center director or any associate center director of the Research Institute
All new SOPs must be prepared in draft form. Writing of draft SOPs may be assigned by the
facility director to an appropriate member of the facility staff. Representative personnel who may
possess knowledge regarding the desired product of the SOP, or who may be responsible for its
administration (stakeholders), must review draft SOPs. At minimum this must include the facility
manager, the facility director, a QA coordinator or specialist, and medical directors and principal
investigators if applicable. It is the responsibility of the facility director to insure that all
stakeholders review drafts SOPs.
The circulating draft SOP must be accompanied by form zzTF-I-001A (New or Revised Draft
SOP Review), and each reviewer must indicate on the form that they have read the draft SOP, and
indicating what changes, if any, they have made to it. Changes may be made directly to the
electronic document, but must be clearly noted prior to passing the document to the next
All new SOPs must be validated (what range of results is obtained if the SOP is followed, and is it
acceptable). These tests are described in detail in the next section.
3. Generation of New Procedural SOPs
Procedural SOPs are to be developed according to the flow diagram in Figure 1.
New procedural SOPs generally will start in pre-clinical studies wherein the methodology
associated with scaling up from research lab to clinical production must be worked out. The
technologist performing the pre-clinical studies will write the initial draft SOP.
The facility manager, who is responsible for production from the finalized SOP, will do initial
review on the SOP, and make preliminary edits to put it into a form consistent with production
The facility director will review the draft, as edited by the facility manager, and circulate for
review to the relevant medical director and principal investigator(s).
The reviewed SOP will be returned to the facility manager who will assign it to one of the facility
technologists. The technologist will first determine if the SOP is understandable. If it is not, it will
be returned to the manager for further editing, and then will also recirculate to the facility director,
medical director and principal investigator(s). The same technologist will also work with the
facility manager and director to develop draft worksheet forms for the SOP, and using those forms
will verify and validate the SOP (see section on verification and validation below), and record
findings on form zzTF-II-009.1 (Validation). Failure in either verification or validation requires
that the SOP be returned to the pre-clinical testing technologist.
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POLICIES & PROCEDURES