INSIGHT REPORT
Vol 4  #6
June
2001

INSIGHT REPORT

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Webster’s definition of a Preamble is, "an introductory statement of a statute that usually states the reason for and intent of the law; one indicating what is to follow."

If you are not familiar with the Federal Register Announcement of Monday October 7th, 1996, especially the Preamble, then the following could provide some real insight into your level of QST compliance.

During a recent FDA inspection, conducted by a very experienced FDA investigator, it was noticed that at the beginning of the inspection the investigator pulled out several references for his use during his inspection.

One of the documents was the FDA QSIT manual. This was understandable in that the firm was notified that this was going to be a level II QSIT audit prior to his arrival.

The other document was a battered up, stack of paper with one of those large winged clips holding it together. It looked as if this document had seen many battles and had its better days behind it.

As the inspection progressed, the investigator was seen going to that document more and more and to the QSIT manual less and less. We were able to observe that this was a Federal Register Document and on each page there were huge sections highlighted with green, yellow or blue colored highlighter.

What was this document and why was it so important in that is appeared to be the main reference for the investigator? The company being audited wanted to know what he was reading and why was he using such a reference and if they could have access to it also.

What the investigator was making such good use of was the original Federal Register document for the final rule for the Quality System Regulations, dated Monday, October 7, 1996. Why would an investigator use this document that was approximately 60 pages long, printed on both sides with maybe a 10 font print, making it difficult for almost anyone over the age of 45 to read? (That is without their reading glasses.)

If you are not familiar with the Federal Register or with FDA Final Rules and you are responsible for the regulatory compliance for your company you better learn more about these documents.

All federal regulations require publication and a request for comments prior to the issuance of the "final rule". The Quality System Regulation, the revision to the GMP regulation had to follow this procedure too. In the Oct. 7, 1996 Final Rule, the FDA had to provide all the comments made to the agency concerning the new regulations along with the agency’s responses. So what makes this document so important compared to say the QSIT procedures, which tells the investigator how to conduct a QSIT inspection?

The Final Rule has the FDA reasoning and rationale for their decisions for how the Final Rule was to be published and implemented. This information is published in the Supplementary Information section of the Final Rule, or Preamble.

In Section V. Responses to Comments and Rationale for Changes, the FDA provides all the comments made, in this case approximately 280 separate individuals or groups commented on the proposal that was published in the Federal Register of Nov. 23, 1993, and 175 separate individuals or groups commented on the Working Draft that was announced in a notice of availability published in the Fed. Reg. of July 24, 1995.

As a result of these comments the FDA made changes in the Final Rule concerning clarity, understanding and readability or further harmonizes FDA requirements with international standards.

So what makes this document so important that an FDA investigator would put an inspection on hold while he tenaciously reads this document?

Firstly, let me explain that you will not see many investigators do this. As a matter of fact, you will hardly see any of the investigators do this. But, if you do, it is because this investigator is trying to understand the FDA’s rationale for their final decision and how that could be applied to your situation.

If you never read the Federal Register for this Final Rule, it could be an interesting document to read (though at times you may have a hard time keeping awake, like with most regulatory documents they have a tendency to put you to sleep). This document will provide some insight into the FDA’s thought process as to why they wrote the regulations the way they did and it could possible provide you some ideas into your compliance strategy and determine if they fit with the FDA interpretations.

If you are lucky enough to get such an investigator (the reason I state, "lucky enough", is that if an investigator is going to use such an document it is because they are looking for interpretation and rationale of the regulatory policy, not just for the black and white written word, and this could provide for a much better inspection) you should expect a very comprehensive audit. But, an audit that is usually fair and not just one sided.

So, if you have some valuable free time this maybe one Federal Document well worth taking a look at and reading a little more closely. You may come out this more than a good nights sleep.

For more information on this Insight Report or a copy of Oct. 7, 1996 Federal Register, please email us at: info@mdiconsultants.com We look to hear from you and we will respond to all your comments.

Next Insight Report - To Be Announced.

If you have any comments on these INSIGHTS we hope that you let us hear them. If you have any of your own INSIGHTS that you feel would be of value to other companies, we would be pleased to hear from you and to discuss them with you and if you allow, we would even put them up on this site for others to learn from.
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