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By year end 2010, FDA is planning to release new regulations that will include requirements for Pharmaceutical manufacturers to physically audit their vendors, no longer allowing paper audits to be acceptable. This change is being considered because of the large number of gaps being found in manufacturers’ quality systems due in part to the growth of production outsourcing. It is expected that once the drafting process of these proposed regulations is completed, they will be available for review and comments for approximately three to six months.
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| Brian Hasselbalch |
According to Brian Hasselbalch, representing the Office of Compliance’s Division for Manufacturing and Drug Product Quality within FDA’s Center for Drug Evaluation and Research, at a conference held jointly by the agency and Xavier University in Cincinnati, Ohio, June 13-16, “between 2001 and 2007, the number of products manufactured outside the United States and the number of manufacturing sites abroad doubled. Some of the new products being imported into the US come from countries with less developed regulatory systems.”
As indicated in the U.S. Food and Drug Administration (FDA) Guidance for Industry Q10 Pharmaceutical Quality System, which is in accordance with 21 CFR Part 820.50, Pharmaceutical companies are ultimately responsible for ensuring that processes are in place to assure the control of outsourced activities and quality. In doing so, companies should implement processes to access the suitability and competence of a vendor prior to outsourcing operations or selecting them as a vendor. This can be accomplished by establishing approved procedures, performing audits, and ensuring qualifications. Note that defined quality requirements should be used during the auditing process to ensure the vendor is capable of meeting these requirements. The evaluation results should be documented.
If it is determined that the vendor is qualified, an approved, written agreement, often referred to as a Quality Agreement, that defines quality requirements, responsibilities, and communications necessary for quality-related activities, should be created and approved between the two parties. Records of acceptable vendors should be established and maintained via an Approved Vendor List.
If a company does not have an Approved Vendor List, it cannot be concluded that vendors being used by the company are qualified to provide the products and services being used for cGxP purposes. With the establishment of an Approved Vendor List, a company can work smarter, not harder. A company will be able to determine if a qualified vendor is currently available that can provide the necessary products or services instead of going through the entire qualification process each time a new vendor is needed. It also ensures that several vendors are not being used for identical products or services. In the end, this will result in better utilization of resources, an improved state of regulatory compliance, and a cost reduction for the company.
However, having these procedures in place does not ensure proper implementation of them. Training should be conducted and documented on these approved procedures, emphasizing the need for quality in all aspects of the vendor qualification process including ensuring that all required vendor assessment and auditing documentation is stored in a centralized, secure location.
A vendor audit does not have to be conducted by a company representative. It is acceptable to use contracted resources to perform these audits as long as the resources are qualified to perform the tasks and the qualifications are documented. According to Hasselbalch, “We will not demand that you individually audit. We acknowledge and recognize a surrogate or a third party audit arrangement. It may be more efficient and more effective, quite honestly. A third party audit would have to be performed by a credible auditing arm [with] certain characteristics that assure the integrity and the quality of the audits.”
Refer to the links below for FDA MedWatch reports relevant to outsourcing.
I've have been receiving requests to complete audits of some pharmaceutical vendors that are being proactive in being prepared for site audits. I have recently completed an audit of a vendor that met the minimum cGMP requirements, but wanted to improve the company's SOP's, Internal/ External Auditing, Deviation, Safety Program, Preventative Maintenance, Calibration, and Training Programs in order to become the "Best" in their area. They invested the capital and time to ensure they were the leaders in their industry.
ReplyDelete(LinkedIn)
Here is a link to an article that gives some more detail from Brian Hallelbalch's presentation at Xavier in June: http://bit.ly/dth0Xo (LinkedIn)
ReplyDeleteOne of the biggest areas of concerns in previous initiatives was the Auditing of those vendors supplying Computer Software and Automated Equipment. I only, occassionally, log-on to Linked In, so am unsure if there is anything in any of these articles, or initiatives, to see if that issue is covered in this one.
ReplyDeleteLinks etc. would be of hel, if possible please. (LinkedIn)
The Link to the original presentation and some additional information can be found here:
ReplyDeletehttp://www.gmp-compliance.org/eca_news_2086_6343,6518,6500,6472,6498.html
(LinkedIn)
The new regulations for auditing vendors pertains to medical device manufactures as well. We have already had several companies contact us to engage our help in creating or revising their procedures for making vendor audits and with audit training. (LinkedIn)
ReplyDeleteFrom the Author: The mentioned investment will compensate this vendor many times over since industry is becoming more aware of the need for qualified vendors and these types of vendors will be ready to go when products or services are needed.
ReplyDeleteSee additional links, with examples not previously included in the blog: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2003/ucm147636.htm;
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048403.htm; you can also go to http://www.fda.gov to search warning letters regarding this issue.
In my opinion, Quality Agreements are a must have however it is surprising that some industries still do not have them in place. - Teresa Jaworski
This is a good move by FDA.The level of vendors will improve.
ReplyDeleteHowever this will not be burden on manufacturers since can be outsourced to consultants. (LinkedIn)
Will this also affect commercial contract manufacturers and not just material vendors?
ReplyDeleteChuck - yes it will affect commercial contract manufacturers as well.
ReplyDeleteI wonder when we will use our own common sense to do things right. Some of the regulations just seem ridiculous but they are necessary because we did things wrong.
ReplyDeleteI hope FDA does not establish standards about washing hands when we use restrooms. Many of us do not wash our hands. It should require regulations. Who would police them. Just the fact such rules get established is a clear indication that we do not want to do the "right" things.
The blog entry mentioned "the drafting process of these proposed REGULATIONS..." (emphasis added). Do you expect that this will actually be contained in a new regulation (similar to 21 CFR 820.50 and the preamble to the Quality System Regulation), or will a guidance document specific to purchasing and vendor controls be issued first/instead? If a regulation as stated, will this likely be in the next revision to Part 211, or is FDA considering a completely new set of regulations that would apply to all Life Science firms?
ReplyDelete