Are You Ready for an FDA Inspection? Surviving the Audit

When it comes to facility audits, tensions run high, even for the most prepared.  When your facility is being audited, the documents used for evaluation come from the Code of Federal Regulations, 21 CFR 111 (Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements).  These documents review specifications, responsibilities to meet those specifications, written procedures, and laboratory operations.  Here, we focus on the microbial aspect of these requirements.

Microbiology Lab Ready for FDAWhat specifications must you establish?

For dietary supplements, specification limits must be set on contaminants that may adulterate (change) or lead to adulteration of the in process or finished batch.  Documentation as to why these specifications will help to ensure contaminants will not lead to adulteration should be in place.  It is your responsibility to ensure the established specifications are met and properly documented.

What steps should be taken to make sure specifications are met?

Appropriate testing should be in place to be sure specifications are within compliance.  You may also rely on a certificate of analysis (C of A) from the supplier of the component that you receive provided you first qualify that supplier’s certificate of analysis through testing.  If you rely on the suppliers C of A, it should include a description of the testing performed, specifications, and actual results of the test.  Periodic auditing of C of A results is required, and should be part of the microbial testing.  To ensure the finished product specifications are met, the in-process procedure should be in place to monitored and make sure that  unanticipated contamination does not occur at any stage.

Requirements for Laboratory Operations

Written procedures (Standard operating Procedures-SOP), for laboratory operations for tests and examination of product must be in place.  Lab operations should ensure that all lab material specifications and dietary supplement specifications are met.  Test methods should be well documented and validated, and sample-collecting plans should also be in place and followed.

Out of Specification Operations

If specifications are not met, a procedure (SOP) must be present and followed to correct for any error made during processing or testing.  A modified method of testing may be necessary.

Microbiology Lab RequirementsThe Validated BioLumix System

BioLumix generates a customized validation book for each of its customers that include:

Installation qualification (IQ):  Identification and validation of the system components; validation of the environmental conditions; electrical requirements; computer qualification; verifying that all installation steps were followed;  and documentation of instrument calibration.

Operational qualification (OQ):  Verifying that the equipment is properly installed, calibrated and is operational.  It includes a unique SOP for all products and assay combinations to be performed on the instrument; software characteristics and the verification that the software is 21 CFR part 11 compliant; verification that all the instrument functions operate as expected; Verification of the instrument temperature accuracy; and training records.

Performance qualification (PQ): is the most extensive part of the BioLumix validation book. It shows equivalency with USP methodology when following USP <1223> “Validation of alternative microbiological methods”.

BioLumix has some quick tips to be sure that your BioLumix system passes inspection without any fuss.

How to Use the BioLumix Validation Book?

Your customized validation book is a major component in your system, just like the instruments and vials themselves.  Make sure the person in charge of validation knows exactly where the validation book is.  Also, be sure that all pages of the book requiring signatures, are signed by the appropriate personnel, and the operator has a good grasp on the meaning of each attachment.  The training log of attachment 9 should show that appropriate training was provided to all operators.  All SOPs used in product testing must also be included in the book.

Side-by-Side Testing

Attachment 16 in the validation book shows your company’s own product testing and the data generated not only with the BioLumix system, but with the USP plate count method as well.  It generally starts with the report that was generated when samples were first sent to BioLumix for testing.  Since then, your company should have added to this data to show continuity between the BioLumix and plate count methods.  Attachment 18 is much more in depth, showing a wide variety of products, vial types, and specification limits.  This data verifies the comparability between the two methods on a broad spectrum.

Vials and Reagents

Make sure that the vials and reagents in use are within their expire dates.  Also be sure the Certificate of Analysis matches the vials.  It may seem like common sense, but when days get busy, some things may be overlooked.  Be sure all reagents are stored at the proper temperature conditions as specified by BioLumix.

Optical Calibration

It is important that your instruments be calibrated optically at least every 6 months, and full temperature and optical calibration be performed annually.  These documents should be held in Attachment 8 of your validation book.  This will show that care was taken to keep the instruments performing at optimal levels.

By following these guidelines, you should be ready for your audit.  As always, BioLumix is just a phone call away with any questions or concerns you or the auditor may have.

It is important for all to know that BioLumix customers pass FDA microbiological audits without any problems.