GEM City Engineering Cited for Document Controls
A litany of major GMP deficiencies — ranging from inadequate document control procedures, CAPA, device acceptance procedures and procedures to control product — plagued GEM City Engineering and Manufacturing during a Feb. 21 to March 1 FDA inspection of its Dayton, Ohio facility.
The eight-item 483 cited numerous examples of the contract manufacturer’s faulty document control procedures. For example, document changes didn’t include a valid signature of the person approving the change, and procedures referenced documents that were not approved. The CMO’s supplier survey for its medical device metal supplier included a checklist that was not defined in the procedures, the 483 said.
Corrective and preventive action procedures were found lacking because none of the corrective action reports reviewed included a verification or validation prior to closing the corrective action reports.
A corrective action reported was initiated for deficiencies in process validation and included an action item to “write IQ, OQ, PQ procedures for our ISO 13485 Quality System.” However, the director of Quality and Continuous Improvement told the investigator there were no approved procedures for process validation “other than what is defined in their quality manual.”
At least 15 corrective action reports between May 2016 and October 2017 did not include any objective evidence or supporting documentation for corrective actions taken, the agency said.
The contract manufacturer failed to develop production processes that ensured devices conformed to specifications, and production procedures don’t define the manufacturing steps to assemble the SAF-T-Pump device, the FDA said. In addition, there were no procedures that defined acceptance criteria, including test methods for the device.
The FDA said that GEM City Engineering hadn’t documented complaints in the last two years, and it did not have procedures in place to adequately control nonconforming products. It also had not established procedures for device history records, and it did not document or approve the validation of the machines used in manufacturing medical devices.
Read the Gem City Form 483 here: www.fdanews.com/08-16-18-gemcity483.pdf.
Staffing an Audit A critical factor in successful auditing is having the right people conduct the audit, meaning individuals with the right mindset and training to ensure that the audit process is rolled out effectively. Some larger corporations may have full-time auditors who handle all audits throughout company facilities; in that case, a big challenge is hiring and retaining qualified people. But it’s far more common for companies to have part-time auditors picked from among key staff, and it’s important to remember that the auditing duties will take away from the audit team’s “real” jobs, so planning to balance work responsibilities can be a challenge. Employees who perform audit duties in addition to their regular jobs should have the audit responsibilities, including training requirements, included in their official job descriptions. Auditors can come from departments other than quality and regulatory, but it is also important to make sure that part-time, in-house auditors be chosen because auditing is truly a reasonable part of their jobs. Another option for some devicemakers may be to leverage auditors from corporate resources, or from a sister or parent company. This can be a good option from the perspective of ensuring the independence of the auditors and benefits of bringing in fresh eyes who are not involved in the day-to-day operations. Susan Reilly, owner of the consultancy Reilly & Associates, cautioned against assuming that a mandated corporate audit — when corporate policies say that a business unit or facility will be audited at a particular frequency — will count as an internal audit for regulatory purposes. “[These] are typically not viewed as an internal audit by either FDA or by your ISO registrar because it is a mandated corporate rather than one of your internal audit requirements,” she explained. One way devicemakers can ensure truly independent audits is to hire outside consultants or contractors who specialize in device manufacturing audits, but this option is a more costly than relying on internal or corporate resources. Reilly noted that she has seen some smaller companies located near to each other enter agreements whereby they audit each other, which offers similar benefits to a professional auditing contractor without the cost. Excerpted from the FDAnews management report: Effective Internal Audits and Quality Control Units for Devicemakers. |