Darryl Sullivan11.01.05
Deciding whether or not to outsource analytical testing to a contract laboratory is a decision that dietary supplement and nutraceutical companies wrestle with on a daily basis. This is because analytical testing results play a critical role in the product development and quality control activities within these organizations. Furthermore, outsourcing this activity requires placing a great deal of trust in the hands of the contract analytical laboratory (CAL).
For the outsourcing activity to be successful, it is important that the CAL understand the testing needs of the nutraceutical company and develop knowledge of the products being testing and understand intended use of the data. With this knowledge the CAL needs to use the appropriate testing protocols and analytical procedures to ensure that all of the data generated represent the highest level of quality in both precision and accuracy.
Before selecting a CAL, it is helpful to understand their operation and acquire sufficient information to have confidence in the lab's ability to successfully complete the testing project. In order to access the competency of the CAL, you must gain knowledge of the lab's organization and staff. If possible, visit the lab and review the standard operating procedures (SOPs), the testing facility and laboratory equipment. It is important that the CAL demonstrate that it has the appropriate experience to be able to successfully execute the testing project.
To begin the assessment of a contact lab, take a close look at the overall organization. Request a copy of the organization charts of the testing facility. These charts should provide information on the leadership of the testing groups, as well as the total chemistry staff. What is important to determine is if the lab has adequate staff to handle the proposed testing program. The lab should have analytical departments that are dedicated to the testing discipline of interest, populated with a sufficient staff. A definite bonus is a dedicated quality assurance unit, which demonstrates that the laboratory has a commitment to regulatory compliance and scientific standards.
In many cases, a CAL has already been audited by a government agency or other external organization. This is true if the laboratory conducts work under FDA GLP (good laboratory practice) or cGMP (current good manufacturing practice) protocols. If the lab is involved in these protocols, information from the FDA audits is available for review. These audit reports contain valuable information regarding the lab's organization and performance against protocols. Audit reports will also be available from CALs that maintain an accreditation like ISO 17025.
When a nutraceutical company is considering working with a contact lab, it is important that the lab not only has a large enough staff to complete the work, but also that the staff has the required education and experience to conduct the study appropriately. The best way to assess the laboratory staff is to request job descriptions and curriculum vitaes (CVs) for all key employees. These documents should provide details of the analyst's education and area of responsibility. When working with dietary supplements, it is important that the chemists have experience with this type of matrix. Many labs only have experience with food or pharmaceutical testing, and have not demonstrated performance with supplements.
In addition to education and experience, the other critical aspect of the lab staff is training. A CAL that is accredited or conducts regulated studies will have training files for all analytical staff. These files will detail the specific assay training that lab analysts have received and how their performance has been measured. This information will assist in the assessment of the competence of the CAL.
Documentation is critical to a laboratory operation. When you are evaluating a CAL it is important to gain an understanding of its SOPs, and the table of contents from the lab's SOP book is a good place to start. This table of contents should include general laboratory procedures, instrument operating procedures and test method procedures.
The general SOPs should contain procedures for all laboratory activities, including method validation, laboratory record keeping, data review and approval, and an out of specification (OOS) process. Every activity that involves the handling and analysis of samples should be described in an SOP. This includes communication with the sponsor's company regarding normal test results and results that are unusual or out of specification. In general, if you cannot understand the organization of the CAL's SOPs, you will experience difficulties working with this lab.
If the general SOPs appear to be understandable, the next important step is to review the analytical method procedures and the instrument operating procedures (IOP). Of particular importance in the method procedures are the method references. The highest quality method procedures are found in the AOAC Official Methods of Analysis, the United States Pharmacopoeia (USP), or other official methods. The IOPs should explain how the analytical instruments are qualified, calibrated and operated. They should also detail instrument repair and maintenance procedures.
Working with a contract lab "sight unseen" is not advisable. It is helpful to know where the laboratory is located and what the physical size of the lab itself is. A contract lab needs to be totally independent in its location, as well as all of its operations. Any lab that is part of a nutraceutical company or other non-laboratory organization might not be totally independent. Whenever possible it is a good idea to visit the testing facility to view the facility and observe the laboratory operation.
During the visit, ask yourself some key questions. Does the size of the testing lab seem to be large enough to handle your testing program? How old is the laboratory? Keep in mind that older buildings tend to have ventilation problems, so difficulties with contamination may be an issue.
Included in the request to the CAL should be an analytical equipment list. This is because the testing of nutraceutical products requires very specialized equipment. As such, the list should detail the type of equipment that the lab has, the quantity of each type of instrument being used for nutraceutical testing, and the age of the instruments.
Make sure that the lab under review has the required type of instruments, and preferably more than just one. If you have any large projects, you want to make sure that the lab can complete the testing in a timely fashion, and sometimes more than one instrument is required. Instrument redundancy is also important for laboratories to continue testing during routine instrument maintenance or equipment failures.
Because nutraceutical sample testing is highly specialized, it is crucial for the CAL to have appropriate testing experience. For example, what types of samples is the lab most familiar with? Is the majority of its testing preformed on food or drug formulations; what is its background with dietary supplements and functional foods?
It is critical that the laboratory understands the intended use of the testing data. The CAL should make a concerted effort to find out if the test samples are for R&D, product release, routine quality control, or for use in a regulatory submission. This is extremely important because the testing and data recording protocols will differ for each of these testing regimes. The CAL should also understand what the fortification level of each nutrient is, and what the product specification is. If the lab does not request this information, there may be gaps in its operations. Because the test methods are often very different, it is important to understand the lab's experience with both raw material and finished products.
It can be very helpful to have some idea of the customer base for the CAL under consideration. It would be helpful to know, for example, if the CAL has worked for government, academia, trade associations, food companies, drug companies or dietary supplement companies.
When establishing a relationship with a testing lab, the quality of the data is a crucial requirement. The experienced CAL should be in a position to demonstrate the quality of its data to you. This requirement is probably the most important facet of the overall lab assessment.
The quality of the lab data is a function of all of the aspects that have already been discussed: the lab facility, equipment, staff, experience and operating procedures. The testing lab should be using fully validated methods. This information should be documented in the CAL's SOP records. Use of AOAC Official Methods ensures the lab has the most rugged testing procedure, and that the method is fully validated. If the lab is using other types of methods, it is incumbent upon them to conduct a full validation of the testing method.
If the lab has validated its test methods, it should be able to produce data that demonstrates the precision, accuracy and ruggedness of the test method. In addition to the initial validation, the lab needs to demonstrate the performance of its assay procedures over time. This "ongoing validation" is required regardless of what test method is being used in the lab. This can be accomplished by using purchased standard reference materials, or using "in house" reference samples. These control materials should cover the types of samples being tested and the analytes that are being measured. It can be useful for the lab to have control samples at several analyte concentrations.
For a contract lab to fully demonstrate the quality of its data, it needs to have its performance measured by an unbiased external organization. The best way to accomplish this is for the lab to participate in a "proficiency" test program. These programs submit blind samples of known analyte concentration to the labs, and then measure the accuracy of its test results.
Involvement in the scientific community can be another measure of the quality of the laboratory. Has the lab published any of its work? Is it involved with AOAC in collaborative studies? Has it ever been a "Study Director," "Topic Advisor" or "Method Committee Member" for AOAC methods? These can be great indicators of the scientific excellence found among the staff of the analytical laboratory.
Evaluating a Contract Laboratory
Whenever possible, it is a good idea to visit a CAL before doing business with them. If you visit and perform a complete laboratory evaluation, this may take one to two weeks of time. In most cases this is not practical, so a shorter laboratory audit is performed. This requires one to two days. A quick "check list" of items to review with a contract laboratory would include:
Laboratory Accreditation
• Is the lab accredited?
• Does the lab operate under FDA GLP/cGMP?
Laboratory Organization
• Request an organization chart
• Request job descriptions/curriculum vitaes (CV)
Quality Assurance Unit (QAU)
• Does the lab have an independent QAU?
• Request an organization chart for the QAU
Standard Operating Procedures (SOPs)
• Request the table of contents from the lab's SOP book
Laboratory Equipment
• Request a list of all analytical instruments
Laboratory Experience
• Request a description of previous projects
• Review experience with dietary supplements/nutraceuticals
• Review types of methods being employed
• Find out the purpose of the studies
• Ask if the lab can assist with potential litigation
There is no perfect contract testing laboratory. The labs in today's business will range widely in the quality of their operations. It is critical that you develop a thorough understanding of the lab's policies and procedures before doing business with them.
The very best relationship between a nutraceutical company and a contract testing laboratory should be a "partnership." The CAL needs to understand your products and the intended use of the data you are asking them to produce. At the same time, it is important for you to understand the operation of the contract lab and how it will carry out your testing program.NW
About the author: Darryl Sullivan is senior manager at Covance Laboratories, Madison, WI, director on the AOAC International Board, and chair of the AOAC Presidential Task Force on Dietary Supplements. He can be reached at 608-242-2711; E-mail: darryl.sullivan@covance.com.
For the outsourcing activity to be successful, it is important that the CAL understand the testing needs of the nutraceutical company and develop knowledge of the products being testing and understand intended use of the data. With this knowledge the CAL needs to use the appropriate testing protocols and analytical procedures to ensure that all of the data generated represent the highest level of quality in both precision and accuracy.
Before selecting a CAL, it is helpful to understand their operation and acquire sufficient information to have confidence in the lab's ability to successfully complete the testing project. In order to access the competency of the CAL, you must gain knowledge of the lab's organization and staff. If possible, visit the lab and review the standard operating procedures (SOPs), the testing facility and laboratory equipment. It is important that the CAL demonstrate that it has the appropriate experience to be able to successfully execute the testing project.
Laboratory Organization
To begin the assessment of a contact lab, take a close look at the overall organization. Request a copy of the organization charts of the testing facility. These charts should provide information on the leadership of the testing groups, as well as the total chemistry staff. What is important to determine is if the lab has adequate staff to handle the proposed testing program. The lab should have analytical departments that are dedicated to the testing discipline of interest, populated with a sufficient staff. A definite bonus is a dedicated quality assurance unit, which demonstrates that the laboratory has a commitment to regulatory compliance and scientific standards.
In many cases, a CAL has already been audited by a government agency or other external organization. This is true if the laboratory conducts work under FDA GLP (good laboratory practice) or cGMP (current good manufacturing practice) protocols. If the lab is involved in these protocols, information from the FDA audits is available for review. These audit reports contain valuable information regarding the lab's organization and performance against protocols. Audit reports will also be available from CALs that maintain an accreditation like ISO 17025.
Laboratory Staff
When a nutraceutical company is considering working with a contact lab, it is important that the lab not only has a large enough staff to complete the work, but also that the staff has the required education and experience to conduct the study appropriately. The best way to assess the laboratory staff is to request job descriptions and curriculum vitaes (CVs) for all key employees. These documents should provide details of the analyst's education and area of responsibility. When working with dietary supplements, it is important that the chemists have experience with this type of matrix. Many labs only have experience with food or pharmaceutical testing, and have not demonstrated performance with supplements.
In addition to education and experience, the other critical aspect of the lab staff is training. A CAL that is accredited or conducts regulated studies will have training files for all analytical staff. These files will detail the specific assay training that lab analysts have received and how their performance has been measured. This information will assist in the assessment of the competence of the CAL.
Standard Operating Procedures (SOPs)
Documentation is critical to a laboratory operation. When you are evaluating a CAL it is important to gain an understanding of its SOPs, and the table of contents from the lab's SOP book is a good place to start. This table of contents should include general laboratory procedures, instrument operating procedures and test method procedures.
The general SOPs should contain procedures for all laboratory activities, including method validation, laboratory record keeping, data review and approval, and an out of specification (OOS) process. Every activity that involves the handling and analysis of samples should be described in an SOP. This includes communication with the sponsor's company regarding normal test results and results that are unusual or out of specification. In general, if you cannot understand the organization of the CAL's SOPs, you will experience difficulties working with this lab.
If the general SOPs appear to be understandable, the next important step is to review the analytical method procedures and the instrument operating procedures (IOP). Of particular importance in the method procedures are the method references. The highest quality method procedures are found in the AOAC Official Methods of Analysis, the United States Pharmacopoeia (USP), or other official methods. The IOPs should explain how the analytical instruments are qualified, calibrated and operated. They should also detail instrument repair and maintenance procedures.
Visiting the Facility
Working with a contract lab "sight unseen" is not advisable. It is helpful to know where the laboratory is located and what the physical size of the lab itself is. A contract lab needs to be totally independent in its location, as well as all of its operations. Any lab that is part of a nutraceutical company or other non-laboratory organization might not be totally independent. Whenever possible it is a good idea to visit the testing facility to view the facility and observe the laboratory operation.
During the visit, ask yourself some key questions. Does the size of the testing lab seem to be large enough to handle your testing program? How old is the laboratory? Keep in mind that older buildings tend to have ventilation problems, so difficulties with contamination may be an issue.
Laboratory Equipment
Included in the request to the CAL should be an analytical equipment list. This is because the testing of nutraceutical products requires very specialized equipment. As such, the list should detail the type of equipment that the lab has, the quantity of each type of instrument being used for nutraceutical testing, and the age of the instruments.
Make sure that the lab under review has the required type of instruments, and preferably more than just one. If you have any large projects, you want to make sure that the lab can complete the testing in a timely fashion, and sometimes more than one instrument is required. Instrument redundancy is also important for laboratories to continue testing during routine instrument maintenance or equipment failures.
Contract Laboratory Experience
Because nutraceutical sample testing is highly specialized, it is crucial for the CAL to have appropriate testing experience. For example, what types of samples is the lab most familiar with? Is the majority of its testing preformed on food or drug formulations; what is its background with dietary supplements and functional foods?
It is critical that the laboratory understands the intended use of the testing data. The CAL should make a concerted effort to find out if the test samples are for R&D, product release, routine quality control, or for use in a regulatory submission. This is extremely important because the testing and data recording protocols will differ for each of these testing regimes. The CAL should also understand what the fortification level of each nutrient is, and what the product specification is. If the lab does not request this information, there may be gaps in its operations. Because the test methods are often very different, it is important to understand the lab's experience with both raw material and finished products.
It can be very helpful to have some idea of the customer base for the CAL under consideration. It would be helpful to know, for example, if the CAL has worked for government, academia, trade associations, food companies, drug companies or dietary supplement companies.
Demonstration of Data Quality
When establishing a relationship with a testing lab, the quality of the data is a crucial requirement. The experienced CAL should be in a position to demonstrate the quality of its data to you. This requirement is probably the most important facet of the overall lab assessment.
The quality of the lab data is a function of all of the aspects that have already been discussed: the lab facility, equipment, staff, experience and operating procedures. The testing lab should be using fully validated methods. This information should be documented in the CAL's SOP records. Use of AOAC Official Methods ensures the lab has the most rugged testing procedure, and that the method is fully validated. If the lab is using other types of methods, it is incumbent upon them to conduct a full validation of the testing method.
If the lab has validated its test methods, it should be able to produce data that demonstrates the precision, accuracy and ruggedness of the test method. In addition to the initial validation, the lab needs to demonstrate the performance of its assay procedures over time. This "ongoing validation" is required regardless of what test method is being used in the lab. This can be accomplished by using purchased standard reference materials, or using "in house" reference samples. These control materials should cover the types of samples being tested and the analytes that are being measured. It can be useful for the lab to have control samples at several analyte concentrations.
For a contract lab to fully demonstrate the quality of its data, it needs to have its performance measured by an unbiased external organization. The best way to accomplish this is for the lab to participate in a "proficiency" test program. These programs submit blind samples of known analyte concentration to the labs, and then measure the accuracy of its test results.
Involvement in the scientific community can be another measure of the quality of the laboratory. Has the lab published any of its work? Is it involved with AOAC in collaborative studies? Has it ever been a "Study Director," "Topic Advisor" or "Method Committee Member" for AOAC methods? These can be great indicators of the scientific excellence found among the staff of the analytical laboratory.
Evaluating a Contract Laboratory
Whenever possible, it is a good idea to visit a CAL before doing business with them. If you visit and perform a complete laboratory evaluation, this may take one to two weeks of time. In most cases this is not practical, so a shorter laboratory audit is performed. This requires one to two days. A quick "check list" of items to review with a contract laboratory would include:
Laboratory Accreditation
• Is the lab accredited?
• Does the lab operate under FDA GLP/cGMP?
Laboratory Organization
• Request an organization chart
• Request job descriptions/curriculum vitaes (CV)
Quality Assurance Unit (QAU)
• Does the lab have an independent QAU?
• Request an organization chart for the QAU
Standard Operating Procedures (SOPs)
• Request the table of contents from the lab's SOP book
Laboratory Equipment
• Request a list of all analytical instruments
Laboratory Experience
• Request a description of previous projects
• Review experience with dietary supplements/nutraceuticals
• Review types of methods being employed
• Find out the purpose of the studies
• Ask if the lab can assist with potential litigation
Summary
There is no perfect contract testing laboratory. The labs in today's business will range widely in the quality of their operations. It is critical that you develop a thorough understanding of the lab's policies and procedures before doing business with them.
The very best relationship between a nutraceutical company and a contract testing laboratory should be a "partnership." The CAL needs to understand your products and the intended use of the data you are asking them to produce. At the same time, it is important for you to understand the operation of the contract lab and how it will carry out your testing program.NW
About the author: Darryl Sullivan is senior manager at Covance Laboratories, Madison, WI, director on the AOAC International Board, and chair of the AOAC Presidential Task Force on Dietary Supplements. He can be reached at 608-242-2711; E-mail: darryl.sullivan@covance.com.
