7.5 Complaint Handling and Customer Satisfaction Program

This page will address various regulatory issues related to this section of the GMP Institute framework.  Click below to view the issues that are relevant to you.

How soon must firms complete CGMP failure investigations?

Can field investigators review information in a firm's database on manufacturing errors, problems and complaints? Is such a database considered part of a quality assurance internal audit and therefore not subject to routine inspection?

How soon must firms complete CGMP failure investigations?

Reference: 
21 CFR 211.192, Production record review; 
Guide to Inspection of Pharmaceutical Quality Control Laboratories, July 1993

The CGMP regulations, at 21 CFR 211.192, establish the requirement for an investigation, but do not explicitly state a time interval for completing it, including the preparation of a report. Our expectation for "closure" of a failure investigation (including any other "unexplained discrepancy") is that the investigation be conducted and reported in a reasonable time. The Barr decision called this "timely" (see paragraph 23 of that decision).

We see both the 30 day time period in the court decision and the 20 day time period in the referenced inspectional guide as being reasonable or timely; both are guidance and not requirements. The times differ because the Court addressed an investigation by a manufacturing site having a laboratory, whereas the guide addresses investigation in the laboratory only. We see the investigation in the manufacturing site that has a laboratory including other manufacturing aspects along with laboratory aspects.

In discussing this topic, it may be helpful to point out what would not be reasonable, like performing an investigation but not progressing to a decision point as recorded in a final report/decision document, delaying a decision on investigation findings beyond the expiration date of the lot(s) in question, or delaying/excluding the investigation from CGMP or application related records which require their inclusion.

Contact for further information: Nicholas Buhay, HFD-325, 301-594-0098; e-mail: buhay@cder.fda.gov

Reprinted from FDA's Human Drug CGMP Notes, (Volume 5 Number 1), March, 1997.

Can field investigators review information in a firm's database on manufacturing errors, problems and complaints? Is such a database considered part of a quality assurance internal audit and therefore not subject to routine inspection?

References: 
See 21 CFR 211.180(c) General requirements (under Subpart J Records and Reports), 
211.192 Production record review; 
211.198 Complaint files

The database records are subject to inspection. A QA internal audit is a systems self-inspection -- to see if a firm follows its own procedures and has the kinds of controls and records required by the CGMP regulations. The kind of record we would not routinely seek to inspect is the type of report that says, for example, employees are not endorsing batch records properly, or required tests are not being performed.

Examination of production records to spot problems with a product, investigate discrepancies, or determine the need for changes in production and control measures is not a QA internal audit. As such, the database would be subject to inspection.  Furthermore, the FD&C Act, 704a(1)(B) authorizes us to inspect all things in a prescription drug facility that have a bearing on whether provisions of the law are being met.

Reprinted from FDA's Human Drug CGMP Notes, (Volume 4 Number 2), June, 1996.