You are in charge of managing outsourcing for your company and you need to contract an accredited third party laboratory to provide analytical services to support your company’s analytical development. Which lab do you choose, and how do you select the right one out of the thousands of labs available?
The optimal selection of your analytical partner is an essential element to the overall strategy of your business. You are choosing a partner that can not only have significant financial implications for your company but may also affect your company’s reputation and how it is perceived in the marketplace.
To help make the best possible choice, the first step would be to ask a few basic questions and then weigh and rank the answers from all candidates considered. Here are some of the key questions you should ask before choosing an analytical laboratory.
Does the lab have the appropriate accreditations for the range of analytical services you require?
Depending on the type of products and testing services you require, it is important to ensure your laboratory of choice is accredited by the appropriate regulatory body. For example, does the lab comply with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)? Is the facility licenced by Health Canada as a GMP drug establishment and/or registered as a drug establishment with the U.S. FDA? Ask to see documentation to verify the lab’s accreditations.
What types of projects has the lab worked on in the past? Does the lab have experience working in the areas you require?
Ask the laboratory manager to provide you with a list of previous projects completed, testing equipment available, types of dosage forms that can be tested, etc. Make sure that the service offerings and analytical capabilities align with your company’s testing needs.
What are the credentials and experience of the scientific staff?
The staff of an accomplished laboratory will consist of scientists and operational personnel not only with the appropriate credentials but also with the in-depth knowledge, experience and expertise in the areas of analytical and bioanalytical analysis specific to the types of work required by your company.
What types of clients has the lab worked with in the past?
Have they worked with start-ups, major pharmaceutical companies, generics companies, nutraceutical companies, cosmetics companies? Getting a sense of the types of clients a lab has worked with will tell you a lot about how the lab handles projects both large and small. It also provides clues as to their experience with different types of products and methodologies.
Are specific client references available?
Ask the laboratory manager to provide testimonials, case studies or specific examples from current or previous clients. These may also be available on the company’s website. Reviewing a lab’s track record in this way will give you a good indication of what to expect should you choose to hire them for your testing needs.
What is the inspection history of the lab?
Has the lab been inspected by a regulatory agency? If yes, which ones (e.g., Health Canada, the FDA, EMMA, etc.)? What were the findings? The results of a recent inspection can provide you with important information about how the lab operates and any gaps that you should be aware of before contracting them.
Is the lab regularly inspected by customers?
Similar to the previous question, has the lab previously been inspected by clients? If so, what were the results? Is the lab willing to be inspected in the future? These answers will help you assess the lab’s credibility.
Does the lab perform regular audits of your laboratory systems and facilities?
A GLP/GMP accredited facility will conduct self-inspections and process audits on a regular basis according to regulatory requirements and their internal Standard Operating Procedures (SOPs). Reputable labs, even if not GLP or GMP accredited, should have regular audits of laboratory systems and facilities written into their internal quality SOPs.
Are the prices quoted competitive, and are volume incentives available?
Although pricing is typically only a portion of the overall value proposition of a service provider, the prices offered for the required work should be competitive, reasonable and fit within your outsourcing budgets. Discounts should also be available for hitting various testing and/or project volume thresholds. Prices should be concrete for a particular scope of work, with as little open-ended costing as possible and only then with prior approval from your company.
What are the typical turnaround times for testing?
Find out how long it typically takes for a sample to be tested, from receipt through analysis and results reporting. This will help you establish timelines so that your results are made available when you need them to be.
Does the lab have the appropriate equipment with the detection capabilities, limits and throughput required for the range of services your company requires now and in the foreseeable future?
Ensure that the laboratory has the specific equipment necessary to meet your testing requirements. For example, if you are transferring an HPLC-FID method, the lab must have an HPLC-FID to complete the work. Or, if your bioanalytical testing SOPs require redundancy in UPLC-MS-MS, the lab must have at least two UPLC-MS-MS to meet the requirement.
Do you send any testing to external facilities or partner companies for completion?
Find out if the lab outsources testing to other facilities, or if they can complete all of your testing needs in-house. The more work conducted in-house by the primary laboratory the better, as this will reduce the chances of problems occurring due to factors such as reduced control over the external facility, transfer issues between sites and multiple quality systems now being part of the program.
Do your customers have access to their results at any time?
If you require results prior to completion of the study timelines quoted, you ideally want to ensure you have access to the data at any time.
Do you have an established sample inventory and tracking system in place that covers receipt to final disposal?
Having an established quality sample management system for the receiving, labelling, handling, storage and disposal of customer samples is mission critical to a successful laboratory.
How long have they been in operation?
There is a greater level of general comfort that can be gained from choosing a laboratory that has been in operation for a reasonably long period of time. This does not mean the highest value labs are the ones that have been in business the longest, but it is one performance indicator of their experience level and ability to survive for an extended period of time through challenging economic times.
Although these few basic questions are certainly not all-inclusive, getting them answered to your satisfaction will go a long way to ensuring you choose an analytical partner that will not only provide the range of quality value-added services you require to be successful, but will significantly reduce your stress and risk in choosing an analytical partner.
Do you have product testing needs or wish to learn more about third party analytical testing? Contact us today.