Standardizing Standard Operating Procedures' (SOP) Manual to Benchmark Cell Processing Laboratory (CPL) Performance

Background

Healthcare SOPs are now standardized. There are a few hundred routine CPL policies/procedures (P/P) and maintaining SOP Manual (SOPM) becomes a daunting task. SOP of any two labs would not only differ on how to achieve the same task but no two SOPM would equally cover all topics required by regulatory and/or accrediting agency (R/AA).

Amongst the R/AA, JC, OSHA, CLIA, CAP, AABB, FACT & FDA all have oversight claims on the lab, including lab practices and SOPs. Failure to abide may result in catastrophic outcome from citation to shut down and insurance disapproval.

Objective

R/AA have common minimum standards- patient safety is the prime concern, and it may be possible to standardize R/AA requirements so that SOPM for every CPL is identical in content, achieving uniformity across the board.   

Method

In 2008, our CPL had a management change and became an independent lab with a cGMP facility. We inherited SOPs from two departments, a total of 161 policies plus 204 forms. There was confusion and duplication with two dissimilar SOPs and formats, also previous P/P had not been updated to current regulatory guidelines.

Early in 2010, we merged the two sets into integrated, practical and regulatory-compliant documents with novel formatting to distinguish one from the others.  FDA regulations took precedence over other R/AA.

FDA, FACT, CAP and the JC's guidelines were keenly scrutinized prior to addressing the merger. SOPs were sorted into three broad categories: Quality Management, Cell Processing and cGMP.

Result

During the course of this merger, we concluded that only one cGMP policy was required since GMP users had their own program SOP. However, GMP users would be trained in QM policies besides their own P/P. Our current SOPM has 70 P/P, 81 forms & 3 presentations, covering all areas of processing and is compliant with R/AA.

P/P Title	Sub Titles	Forms
I.  Q M
Quality Assurance	Organization; Terminology
Good Manufacturing
Responsibilities	Lab Tech to MD
Security & Safety	Safety manual etc	2
Utility Mgmt	Air Handling; Compressor; etc	12
Training	Training; Competency; CE	2
S.O.P. Mgmt	Writing; Controls	5
Systems	Controls; Validation	5
Event Mgmt		2
Audit		1
Equipment Mgmt	BSC; Incubator etc; PM etc	7
Accreditation Mgmt		5
Supplies		2
E M Mgmt		4
Cleaning, Sanitization		2
Data Mgmt	Documentation; Billing
II.  Processing
HCT/P Quality Assurance	Donor, Patient, Product	3
Quality Testing		1
Chain of Custody		3
HCT/P Manufacturing	From Receipt to Infusion	20
Data Mgmt
Equipment Ops	Cobe 2991; Cell Counter etc	5
III. cGMP
Gowning

Conclusion

Our rationale for standardizing SOPM is based specifically on 21 CFR Part 1271 which governs all CPLs and is mandatory law. With standardization, we will have clarity, identical training for staff, and assurance of adherence to similar methodology as required by law, resulting in consistency, uniformity, legitimacy and safety in our laboratory manufactured products.