Quality Regulations for Drug Manufacturers & Their Suppliers

Douglas E. Purdy

Quite Involved in Discussions
Since I only received one response to my earlier question, I would like recommendations from all those Quality Managers, Quality Representatives, Quality Analyst, and Quality Engineers in the Pharmaceutical Manufacturing Industry as to where the Quality Standards come from. Is it ISO-9001 in conjunction with the cGMPs CFR 210 & 211, and Q7A? Or is do the Quality Standards come from somewhere else that I have not learned about?

Your assistance in this matter would be greatly appreciated. Even if you could steer me to a List Serve or Forum where Drug Manufacturing "Quality" professionals support.

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I really wish I could help you out. I'm borderline on FDA stuff. I don't know if this general dialogue will help or not - but maybe it will trigger some others to chime in.

The bottom line is for years quality systems have had a number of hallmarks. ISO 9001 is 'best practices' in a general way. The FDA, nuclear and military stuff are 'in addition'. What I mean is they typically contain all the hallmarks of a 'standard' quality system plus industry specific practices. The FDA has strict records control / retention features for example. Much stronger than ISO 9001's which let YOU decide what is important and what isn't.

So - you have the 'standard' hallmarks. What are they? basically ISO 9001:1994's 20 elements. Nonconformance system, corrective action system, document control. All these are pretty routine. Calibration - just good business and manufacuring practices. Internal auditing is a derivitive of nuclear mostly, I think[/]. ISO embraced it and it hangs there but I have never considered it a 'hallmark' but it must be said that customer audits have been going on for years. That said, customer audits are more typically product / process oriented.

As I understand it, cGMPs CFR 210 & 211 all are from federal or state regulatory bodies and they are mandatory, unlike ISO 9001 which is not a function of most governments to require, at least not across the board. That said, companies which sell certain items to many european companies are required by their country's government to be ISO registered or more. This is where the 'trade barrier' myth comes into play - as if the US doesn't require certain things of companies outside the US before they sell in the US. An example would be medicines. If a foreign company wants to sell drugs in th US there are one heck of a lot of hoops to jump through. Not to mention internally. Heck - look at all the companies that jumped through the QS-9000 hoop and all those about to dance the TS-16949 dance regardless of the expense.

So - if you see elements of ISO in the GMPs, just remember there are many 'hallmarks' of 'good' quality systems which go back many, many years. Sometimes they may not look like a 'traditional' but they function the same. For example, most companies do have some type of document control and it is typically at least somewhat effective even though not a documented system. That's what print control is all about, for example. If you're injection molding little 2 inch toy soldiers control of records is probably not a big item outside accounting. If you're making heart pacemakers you're going to have extensive trqaining, documentation, many records required by government agencies and such like.

ISO 9001:2000 is just over hyped good business practices.

I have never hear of Q7A so I can't comment there.



It is indeed using the standards found 21 CFR 211; cGMP's for Manufacturing, Processing, Packing or Holding of Drugs.

Part 211 provides the minimum standards (what's) that must be met for the above scope of operations. There are other 21 CFR sections that also apply to the ISO sections. 21 CFR 11 deals with electronic recordkeeping and signature requirements, other 21 CFR sections deal with product development and control, etc.

The FDA web site, www.fda.gov is a wealth of information on the applicable standards for drug processing in the US. The FDA group that deals with Drugs is CDER (Center for Drug Evaluation & Research).

From an auditing standpoint, wou might also be interested in the FDA's inspection program for drug manufacturers. That is issued as a Regulatory Compliance Guideline 7356.002, 2/1/02 (also available on the web site at www.fda.gov/cder/dmpq/compliance_guide.htm). This recently issued guideline finally provides FDA with a method to use a systems based approach to auditing manufacturer's vs. the prescriptive methods they used to.

Finally, you mentioned the Q7A document. That document is only intended to cover what's known as API's (Active Pharmaceutical Ingredients). It is a harmonized and international standard for companies that manufacture the active drug substance that goes into a final drug dose form that is prescribed to you. A good example of an API is acetominophen, which is then used and compounded with other things to become Tylenol, or other branded analgesics.

Hope this helps. Feel free to let me know if you have other questions.

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