Maged Sharaf, PhD, American Herbal Products Association 07.01.16
Contract laboratories provide a variety of services and are often a cost-effective means of meeting your analytical needs. Investing time and resources into the lab selection process can help you avoid future pitfalls.
Contract labs tend to specialize in certain services. The right lab can help companies ensure their products are high-quality and comply with current good manufacturing practice (cGMP) requirements, including testing components of final products to ensure they meet specifications for identity, purity, strength and composition, and documentation of these test results.
This testing and documentation can ultimately help your company make informed purchasing decisions, accurately label products and document substantiation for claims. A good contract lab will also be an invaluable partner that helps demonstrate cGMP compliance when Food and Drug Administration (FDA) officials inspect your manufacturing facility.
Understanding Specifications
The lab you choose must be able to demonstrate knowledge of and compliance with cGMP requirements. Ultimately, it is the manufacturer’s responsibility to assure that contract lab facilities and their operations are adequate and well documented.
Manufacturers must establish specifications and are responsible for determining and documenting that these specifications are met. It is important that the lab understands your specifications and can adequately evaluate and document if specifications are met. These specifications include identity, purity, strength, composition and limits on contaminants like pesticides and heavy metals. Your contract lab is your verification tool, and you want to assure they understand cGMP requirements, especially their application to botanicals.
Goals & Audits
When it comes to contract laboratories, there is no shortage of options, but not all labs are created equal. The first step to successfully choosing a lab is to identify and articulate what you need from a lab. Once you have clearly articulated goals, it is important to audit potential laboratories. Industry experts advise an in-person audit as the most comprehensive and effective. However, this isn’t always possible and you may need to perform a remote audit. In either case, you’ll want to ask the lab the following questions:
Manufacturers can exempt one or more product specifications from verification requirements if it is determined and documented that the specifications are not able to verify that the production and process control system is producing a dietary supplement that meets the exempted product specification and there is no scientifically valid method for testing or examining such exempted product specification at the finished batch stage.
In such cases, the manufacturer must document why any component and in-process testing, examination or monitoring, and any other information, will ensure that the exempted product specification is met without verification through periodic testing of the finished batch. The right contract lab can help you make this determination and document it.
This means your contract lab must be willing to operate in partnership with manufacturers in finding reasonable, cGMP compliant solutions to cGMP requirements. Beware of labs that want to charge an arm and a leg to develop a method even though this may not be the most efficient way to meet cGMP requirements.
AHPA recently presented a webinar to help manufacturers select an appropriate lab. For more information, check out the webinar recording and materials available on the AHPA website at www.ahpa.org.
Maged Sharaf, PhD, is the chief science officer of the American Herbal Products Association (AHPA), the national trade association with a focus primarily on herbs and herbal products. AHPA’s membership represents U.S. and international growers, processors, manufacturers, marketers and institutes specializing in botanicals and herbal products.
Contract labs tend to specialize in certain services. The right lab can help companies ensure their products are high-quality and comply with current good manufacturing practice (cGMP) requirements, including testing components of final products to ensure they meet specifications for identity, purity, strength and composition, and documentation of these test results.
This testing and documentation can ultimately help your company make informed purchasing decisions, accurately label products and document substantiation for claims. A good contract lab will also be an invaluable partner that helps demonstrate cGMP compliance when Food and Drug Administration (FDA) officials inspect your manufacturing facility.
Understanding Specifications
The lab you choose must be able to demonstrate knowledge of and compliance with cGMP requirements. Ultimately, it is the manufacturer’s responsibility to assure that contract lab facilities and their operations are adequate and well documented.
Manufacturers must establish specifications and are responsible for determining and documenting that these specifications are met. It is important that the lab understands your specifications and can adequately evaluate and document if specifications are met. These specifications include identity, purity, strength, composition and limits on contaminants like pesticides and heavy metals. Your contract lab is your verification tool, and you want to assure they understand cGMP requirements, especially their application to botanicals.
Goals & Audits
When it comes to contract laboratories, there is no shortage of options, but not all labs are created equal. The first step to successfully choosing a lab is to identify and articulate what you need from a lab. Once you have clearly articulated goals, it is important to audit potential laboratories. Industry experts advise an in-person audit as the most comprehensive and effective. However, this isn’t always possible and you may need to perform a remote audit. In either case, you’ll want to ask the lab the following questions:
- Does the lab have a quality control manual? And will it be possible to share an outline or table of contents with you?
- What testing does the lab perform in-house and what testing does it outsource to other labs? Have they audited the other labs? How do they handle questionable results from the outside lab?
- Does the lab have an independent quality assurance (QA) department?
- Is the lab accredited with any organization? If so, which one(s)? Note: ISO 17025 certification is on a per-method basis. If the lab has ISO 17025, ask for which methods.
- Does the lab follow any published standard of good laboratory practices? If so, which ones.
- What does the lab do when test results are unexpected or don’t meet specifications? What does the lab do when there are conflicting test results?
- How does the lab handle samples from the time of receipt, through lab analysis, report issuance and data archiving?
- Does the lab provide support and transparency with the test results?
- Does the lab have written procedures and schedules for instrument and equipment maintenance and calibration? Is this documented and can they share that documentation?
- Does the lab have written valid test methods for the sample analysis? Can the lab disclose the test procedures and methods used? How does the lab assure test results are accurate and precise? This will enable you to independently verify results by providing the lab’s method of analysis to another lab that can duplicate the test.
- Who performs the testing and what are their qualifications? How much experience does the lab and the analyst have in dealing with the specific analyte and matrix?
- What is the average cost and time it takes to complete testing and deliver results?
- How does the lab record raw data? Can a final report be tracked back to the original raw data? How long does the lab retain raw data and does the lab provide that data upon request?
- Does the lab provide documentation when there is no scientifically valid method for testing or examining any exempted product specification at the finished batch stage?
Manufacturers can exempt one or more product specifications from verification requirements if it is determined and documented that the specifications are not able to verify that the production and process control system is producing a dietary supplement that meets the exempted product specification and there is no scientifically valid method for testing or examining such exempted product specification at the finished batch stage.
In such cases, the manufacturer must document why any component and in-process testing, examination or monitoring, and any other information, will ensure that the exempted product specification is met without verification through periodic testing of the finished batch. The right contract lab can help you make this determination and document it.
This means your contract lab must be willing to operate in partnership with manufacturers in finding reasonable, cGMP compliant solutions to cGMP requirements. Beware of labs that want to charge an arm and a leg to develop a method even though this may not be the most efficient way to meet cGMP requirements.
AHPA recently presented a webinar to help manufacturers select an appropriate lab. For more information, check out the webinar recording and materials available on the AHPA website at www.ahpa.org.
Maged Sharaf, PhD, is the chief science officer of the American Herbal Products Association (AHPA), the national trade association with a focus primarily on herbs and herbal products. AHPA’s membership represents U.S. and international growers, processors, manufacturers, marketers and institutes specializing in botanicals and herbal products.
