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Private Laboratory |
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Last Update: March 25, 1997
| Sponsored by: Division of Field
Science Office of Regional Operations Office of Regulatory Affairs U.S. Food and Drug Administration (301) 443-3320/(301) 443-6388 (FAX) |
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| Introduction | Proposed Action Plan |
| Attachements | |
Recently, the Food and Drug Administration (FDA) held four public Grassroots Meetings throughout the Nation. The meetings consisted of stakeholders from domestic, import, private laboratory communities, and trade associations. These public meetings were held in Brooklyn, New York; Orlando, Florida; Houston, Texas; and Oakland, California; during the months of June and July 1996. As an outcome of these meetings, positive comments were received relating to the role of private laboratories and FDA among the stakeholders comprising of the more than 175 private industry participants and 50 FDA staff members.
Objectives of these meetings were as follows:
The participants were asked to address many issues concerning the coordination of the FDA and private laboratory services. Issues included specific questions about FDA policies, practices or procedures. Recommendations from stakeholders were requested to change FDA polices and procedures so that the private sector could expedite the testing of products in commerce and complement FDA in consumer protection. Most important to FDA's mission is consumer protection. In the same token, if private laboratories are to be advocates in FDA's mission. It is essential that private laboratories produce credible data for the FDA to make regulatory decisions.
Summaries of the plenary sessions for each of the four meeting s are included in Section IV. Both the Plenary Session Summaries and the Workshop Minutes were captured by various FDA personnel in attendance at each meeting and are included in this report.
The minutes of individual workshops were recorded by a variety of mechanisms including hand written notes, flipcharts, and laptop computers which were operated by meeting facilitator during each meeting. All notes taken by FDA personnel were transcribed and consolidated. Names were purged to preserve anonymity of the stakeholder. All comments are included in this report organized in the plenary session summaries, Section V, listed by workshop. The editing which occurred at ORA headquarters was kept to a minimum, as every attempt was made to insure that the integrity of the minutes was maintained throughout the consolidation process.
The term "private laboratory" refers to those private sector laboratories which conduct testing of regulated products and submit analytical data to the FDA to demonstrate compliance with the FD&C Act. The term includes only those laboratories which not regulated by Good Laboratory Practices and/or Good Manufacturing Practices. By definition, private laboratories are independent providers of analytical services and are not directly associated with firms utilizing their resources.
FDA's current use of private laboratories includes activities as follows:
FDA's Potential use of private laboratory data for FDA may include as follows:
FDA proposes to take the following the steps in response to the ideas received from the grassroots meetings.
Analytical data standards will be established nationally and will be applied consistently and objectively throughout FDA.
FDA proposes to clarify its policy and provide guidance for the submission of analytical packages for a private laboratory for compliance decisions. FDA reviewers will be appropriately trained to evaluate analytical packages in a consistent manner so that private laboratories can expect fair and equitable treatment no matter the servicing district. In an effort to bring about consistent reviews of analytical packages FDA sponsor training workshops and teleconferences for analysts, import managers and compliance officers. FDA will change policy and procedures for evaluating private laboratory submissions and will revise the Laboratory Procedures Manual (LPM), Chapter 21. Also to be revised is guidance for products detained without FDA analysis, presently contained in the Regulatory Procedures Manual (RPM). FDA's Office of Regulatory Affairs (ORA) will provide guidance and oversight to all reviewers of private laboratory packages. ORA's, Division of Field Science (DFS) will coordinate, with input, both Centers and Districts to resolve technical issues and provide guidance in testing. DFS will administer and coordinate all scientific issues to assure consistent application of internal procedures.
FDA will strive to provide better customer service to the private sector.
FDA plans improved timeliness in making compliance decisions based on private sector testing. DFS will monitor the efficiency of the districts in reviewing and making compliance decisions on private sector analytical results. DFS will track the timeliness in reviewing analytical work by using management tools such as, the Laboratory Management System (LMS). In the near future, FDA will be using the Field Accomplishments and Compliance Tracking System (FACTS) which will provide better customer service. Analytical packages received from private laboratories will be tracked in a similar manner as are internal FDA laboratory samples. The Operational Administrative System for Import Support (OASIS) will assist in tracking audit samples and store analytical data on imported products tested by the private laboratories.
To improve customer service, ORA identified the Internet as a means to foster communication between its customers. Through the Internet, ORA has made inroads to improve customer service. The Office of Regional Operations (ORO) continues to be active in providing regulatory guidance by featuring Import Alerts on FDA's world wide web (www) homepage. Interested parties can keep informed of FDA's administrative and regulatory functions. The homepage has helped reduce the burden on FDA staff to provide public information. The ORA homepage is currently accessible via the FDA homepage (http://www.fda.gov/ora) which includes an overview of ORA operations, information on the import program, inspectional references, science references and compliance references. The minutes from all the grassroots sessions are accessible through the ORA home page.
Plans are in effect to update the ORA homepage to include documents such as the Regulatory Procedures Manual , the Investigations Operation Manual, Compliance Policy Guides, Laboratory Information Bulletins and the Laboratory Procedures Manual. ORA plans to include a listing of District contacts for issues related to private sector sampling and analysis of regulated products and will make this list available on the web site. Since, the compliance status of products, is determined primarily in the districts, the Compliance Officer or Import Manager will be identified as the primary contact persons.
Methods to test products will be included in Import Alerts. As a note, a method cited in an Import Alert may not be the method applied to detect the violation. Often there are several methods to determine the compliance status of products. If the private laboratory wishes to choose another method, equivalency must be clearly demonstrated in the analytical package submitted to the agency. FDA laboratories proposes to be proactive in encouraging discussions with private laboratories for modifying methods and working collaboratively to assure the highest quality of science.
FDA will utilize training as one of several solutions to the issues raised by the grassroots participants.
Yearly, FDA identifies its internal training needs of its staff. As one of the efforts to improve the handling of private laboratory submissions, the FDA will focus its training needs on the "standardization" of agency reviewers. In certain cases, an effort to cross train scientists may be possible in both FDA and private laboratories as practical means to bring about standardization. In keeping with Vice President Gore's National Performance Review (NPR) and the Reinventing Government (REGO) initiatives, FDA is allowed to work within a partnership approach to assure consumer protection. By the formation of a partnership and through cooperative training effort a cultural shift can be envisioned to assure consumer protection for the American public. It is also important that FDA use it's resources more efficiently by knowing that the analytical work submitted by the private sector be assessed confidently.
FDA is expected, by Congress, to maintain its duties as regulator and expects that private laboratories will function objectively and in a non-biased manner to support FDA's mission. Private laboratory data is expected to meet an equivalent high quality standard of FDA laboratories.
Private laboratories have identified their training needs. Private laboratories have expressed to FDA the need for training in FDA import procedures, as well as, specific requests for sample collection techniques. Also, private laboratories have addressed training needs for establishing general criteria requirements for product compliance.
Private laboratories have pointed out that joint training efforts between the private sector and FDA scientists should be occurring on a more frequent basis. FDA agrees that standardization is necessary and especially apparent with organoleptic/sensory and sanitation analyses due to the subjective nature of the analyses.
A wide range of expertise in laboratory sciences exists among FDA staff and the private laboratory. FDA proposes to also utilize FDA Science Advisors as a valuable resource in developing and conducting joint training sessions.
FDA funding resources are limited; as are the private laboratories, identified mostly as small businesses. Through a partnership approach, along with creativity from both sides shortages in resources for developing joint training programs can be overcome.
Independent Sampling will be mandated.
FDA proposes to rescind Compliance Policy Guide 7150.04, Section 110.80 Imports, Post Detention Sampling. The compliance policy grants the importer, with no objection from FDA, to voluntary collect and examination representative samples from a detained lot.
As result of the grassroots discussions, FDA intends to reissue new guidance to describe that an importer will have independent sampling for examination of detained shipments. By mandating a sampling requirement by a private laboratory or other independent service, it would provide confidence to FDA that sampling is expediently collected and properly represented of a lot. The new guidance will also serve as quality assurance for private laboratories by demonstrating that the laboratory is capable of consistent analytical results.
Any interested party will be required to notify FDA before their intent to have products sampled and tested by the private sector. This will also allow independent sample collectors to collect samples for private laboratories. By this procedure, FDA can monitor and have assurance that products are not "tested into compliance." The FDA also agrees to make any means possible to expedite notification to sample and examine shipments.
For imported products a notification of intent to contract for private sector sampling and analysis can be submitted electronically using the EEPS for imported products.
In the case of domestic products notification can be made by fax until such a time as the FDA can accept information using an electronic system.
Private laboratories which are contracted to perform sampling and examinations of products will be required to document analytical ability. Any documentation on laboratory ability would be provided in advance to any product sampling and testing.
As recommended, FDA is willing to work with the private laboratory industry to develop guidelines for assessing laboratory analytical ability. FDA also proposes to work collaboratively with private laboratories in designing a collection report which will document sample collection and identification of samples at the time of collection and accompany that sample during its shipment to the private laboratory. The private laboratory contracted by the product owner will be required to maintain records to verify a sample at the time of collection by the private laboratory. On occasion, FDA may request an opportunity to examine all records associated with the samples collected during normal business hours.
Direct reporting of analytical results will be required.
Private laboratories are obliged to report unbiased analytical results directly to the FDA. Private laboratories would be expected to submit tests results simultaneously to FDA and owners of the shipment. Consumer protection can only be assured when FDA can act quickly upon test results. FDA must rely on the private laboratories to produce non-biased analytical data to determine the product's compliance.
FDA will continue to audit private laboratory results and perform assessment visits.
For the purpose of this grassroots initiative, the private laboratories communities are defined as those which are not directly regulated by FDA. These private laboratories are not required, by law, to assure they are in compliance with Good Laboratory Practices and Good Manufacturing Practices. However, it is FDA's hope that the private laboratories will follow the spirit of the these regulations. Under certain circumstances private laboratories may have clients where they would be considered as an extension of the manufacturing process; e.g. release testing finish products; which may require compliance to Good Manufacturing Practices or the testing of certain samples would come under Good Laboratory Practices.
FDA does not plan to expand inspectional authority to include private sector laboratories. FDA believes inspection authority for private laboratories would be resource intensive. Instead, FDA will continue to perform assessment visits as current practices dictates.
The collection of audit samples by the FDA, for specified lots, will continue as current practice. Sampling will be used to assess the compliance status of the product. To assess the competency and proficiency of the private laboratories, FDA will use reserve portions of samples collected by private laboratories or their sampling agent. Stakeholders will work together in establishing an audit schedule. Discrepancies in analytical results between FDA analysis and the private sector will be settled based on non-biased scientific principles and procedures acceptable which are to the agency.
FDA will vigorously pursue protecting the public interest to assure that processes and procedures maintained by private laboratories and FDA will always preserve the highest levels of integrity and honesty.
FDA will initiate pilot programs designed to enhance the use of the private sector in sampling and analyzing regulated products.
FDA will considered pilot programs which allow for private sector sampling and analyses of products. FDA will initiate programs that appear to be beneficial to assure consumer protection. Pilot programs may include participation from all stakeholders including those who perform the sampling and analysis, product manufacturers, growers, processors, importers, brokers, consumer groups, scientific and trade associations and the FDA. A concerted effort will be made to keep audits, procedures and practices of both imported and domestic programs on a level playing field. The pilot programs will be designed within the framework of the Government Performance and Results Act, National Performance Review as well as Congressional mandates and legal requirements.
The cost of private sector sampling and analysis will necessarily be borne by the product owner or other interested party. The pilot programs, as well as any general option extended to regulated industry to have their products sampled and tested will depend on the extent to which the private sector can demonstrate their competency and credibility. The criteria for assessing the competency and credibility of the private laboratory will be demonstrated by the ability of the private laboratory to perform the analytical work necessary to assure that the U.S. consumer continues to enjoy a safe and wholesome supply of products FDA regulates. Credible science will demonstrate with certainty and confidence, that the analysis was performed in a reliable, reproducible, accurate and truthful manner.
FDA will consider the future possibility of laboratory accreditation, in the context of how effectively the proposed actions achieve appropriate outcomes in our relationship with private laboratories.
FDA is studying laboratory accreditation issue and is examining the various models that presently exist. Because of FDA's special regulatory responsibility and legislative mandate, FDA must resolve complex issues to address and assure adequate consumer protection.
