Understanding the purpose of SOPs is one thing; complying with the FDA's regulatory standard for ensuring that employees have
the knowledge they need to perform their job functions is something else entirely. Large companies may have thousands of job
tasks, each one requiring an SOP that usually needs regular updating. Even small companies will have extensive SOP requirements,
whether it's for regular equipment calibration or for sterile manufacturing procedures. In fact, FDA has specifically identified
operational areas that fall under cGMP and—by extension—SOP regulation. The components for which employees must have sufficient
knowledge to perform their job functions adequately, range from buildings and facilities to equipment, components, and drug
product containers and closures, production and processes, packaging and labeling, holding and distribution, laboratories,
and returned or salvaged drug products.
In general, SOP compliance incorporates activities that can be grouped into five categories:
1. Creation of a quality control unit responsible for ensuring SOP compliance
2. SOPs for each job task that are updated and understandable to employees
3. Accurate, timely distribution of SOPs to all responsible parties, validation that the SOP has been received and read
4. Confirmed employee comprehension of the SOPs and the ability to apply the knowledge contained in the SOP
5. Comprehensive corrective and preventive action program to identify rectify and prevent quality failures.
The Quality Control Unit
FDA signaled a new approach to cGMP compliance by pharmaceutical and biotechnology companies in September 2004. The Agency's
"...modern quality systems and risk management approach" to cGMP emphasized management responsibilities for quality control
and assurance. That responsibility included formation of a quality control unit that "... shall have the responsibility and
authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material,
labeling, and drug products." Although the compliance responsibility of the quality control unit is not limited to SOPs, an
effective SOP compliance program is central to the unit's ability to fulfill its mandate.
Although life sciences companies routinely embrace the most advanced technologies in the laboratory and manufacturing plant,
many companies have not been as receptive to technology managing their SOP activities. Given the scope of modern SOP compliance
responsibilities and the consequences of noncompliance, companies increasingly recognize the value of using technology to
comply with SOP mandates. Not coincidentally, the same system that supports SOP compliance can also easily serve as the foundation
for improving a company's overall quality control management and assurance effort.
An effective SOP compliance program requires a technology-enabled platform that is interoperable with existing technologies
and performs multiple functions, including SOP distribution, validation, testing, and recordkeeping in audit-ready formats.
Because SOPs require revision with every process change, equipment replacement, or regulatory change, any SOP management technology
should enable rapid updating and distribution. Just as important, the system should allow effective targeting of SOPs to the
correct employees, thereby preventing all employees from being overwhelmed by SOPs not applicable to the individual's job
The Written Word
The FDA requires that SOPs be in a written format. Violation of that basic requirement is routinely found in FDA's Form 483
or in Warning Letters for a variety of operations throughout the regulated process. Significant deviations noted by FDA in
recent Warning Letters illustrate the range of activities that may be targeted for failure to meet the written SOP standard.
1. Failure to establish and follow appropriate written procedures designed to prevent microbial contamination of drug products
purporting to be sterile
2. Failure to establish written procedures applicable to the function of the quality control unit
3. Failure to establish written procedures for evaluating quality standards of each drug product to determine the need for
changes in drug product specifications of manufacturing and control procedures
4. Failure to develop written procedures for surveillance, receipt, evaluation, and reporting of postmarketing adverse drug