As good manufacturing practices (GMP) requirements and consumer sophistication pushes the demand on traceability and accountability, the importance of thirdparty testing continues to grow as a viable conduit for companies to demonstrate ingredient stability, purity and lack of contamination. Nutrition Industry Executive (NIE) asked the following testing experts about the programs available that help provide peace of mind:

• Cindy Lieberman, Vice President of Illinois-based Celsis Rapid Detection

• William J. Rowe, President and CEO of Nutrasource Diagnostics Inc. (NDI) in Canada

• Elan M. Sudberg, CEO of Californiabased Alkemists Laboratories 

NIE: What testing services does your company provide?

Rowe: Our company provides a wide range of testing and analytical services to help companies that fall at any point along the value chain, including raw material suppliers, finished product manufacturers, product branders and any other party that wishes to verify the safety, quality and stability of their product.

These include but are not limited to:

• Active ingredient testing

• Microbial testing

• Heavy metals

• Allergen testing

• Persistent environmental contaminants (e.g., PCBs, dioxin-like PCBs, dioxins and furans)

• GMO testing

• Banned substance testing

• Dissolution testing

• Real-time or accelerated stability testing according to ICH guidelines

• Method development services 

All testing is run in accordance with USP, Ph. Eur, AOCS, AOAC and USEPA methods.

Lieberman: Celsis Rapid Detection is a world leader in rapid microbial methods (RMMs). Our systems provide significant economic value and cost savings to customers by reducing the time it takes companies to test and release raw materials, in-process goods and finished products to market. Celsis develops technology for its advanced screening systems (instruments, software, reagents and support services) that rapidly detect microbial contamination in home and beauty, food and beverage and pharmaceutical products.

Sudberg: Alkemists offers cGMP identity tests including botanical microscopy, high performance thin layer chromatography (HPTLC) as well as a wide variety of HPLC (High Performance Liquid Chromatograph) and UPLC (Ultra-high Performance Liquid Chromatograph) methods for botanicals, active and cosmetic ingredients.

NIE: How can your company’s services help manufacturers lower product cost, address safety issues, etc.?

Rowe: Our company tests products along the supply chain from the raw material stage to post-packaging and end product form to ensure that products are safe, stable and meet label claim for active ingredients. In addition, we offer full-scale GMP facility auditing to help ensure that our clients’ manufacturing facility is running in accordance with government regulations, their product is compliant.

Lieberman: Within lean manufacturing, one of the biggest culprits of waste is delay based on inefficient processes or movement of goods. But manufacturers can literally cut days out of their cycle times with rapid detection, which enables companies to quickly detect microbiological contamination in raw materials, in-process and finished goods.

A rapid product release-screening test from Celsis delivers definitive results 80 percent faster than traditional microbial methods, so home and beauty, food and beverage, and pharmaceutical manufacturers can reduce hold times, reduce inventory requirements and reduce costs—without compromising quality—while freeing up working capital.

Sudberg: We address safety by confirming that what is on the label is in the bottle from finished products all the way back to a bag of raw un-ground herbs. Alkemists helps to improve product performance and return sales by ensuring the test sample meets specs and contains the correct genus and species of botanicals or the correct amount of actives claimed.

Unfortunately, our effect is commonly to increase manufacturers product costs as they finally invest in meaningful, accurate and fully disclosed analytical tests to ensure only the highest quality products make it to the shelves. It’s up to them to market this additional expense and twist it into a value proposition to help justify higher prices than lesser competitors.

NIE: Does your company address product failure issues?

Rowe: Yes—for products that do not test to the clients’ specifications on a given submitted sample, we perform OOS (out-of-specifications) investigations.We also consult directly with companies in these situations to help get their products and facilities up to the proper regulatory standard.

Sudberg: Daily, and we don’t just stop after failing something. There is a formal OOS procedure written into all our SOPs dictating the steps to take when a test sample doesn’t meet spec. Further, we make ourselves available to the customer and sometimes their vendor to discuss possible reasons the material failed. Ultimately, if we can make recommendations, we will, all in effort to help our customers get on track for a successful product.

NIE: How does your company analyze for government compliance? Do you test finished products as well as ingredients?

Rowe: NDI arranges for panels of testing by product type and by jurisdiction to ensure the client’s QA/QC and regulatory needs are [in line] for government compliance, both as finished product as well as ingredients.

Lieberman: A rapid screening system will quickly test raw materials, in-process goods and finished products for the presence of contamination. For those products expected to be free of bioburden, with plates that rarely show colony-forming units, a Celsis rapid release system is ideal. It quickly confirms the absence or presence of contamination and enables companies to release in-spec product to market quickly.Acceptance criteria are determined at the time of validation. The Celsis system includes installation, on-site training and validation setup. Plus, our Drug Master File is on record with the FDA to speed approvals.

Sudberg: While as a lab we strictly follow and understand cGMPs, we don’t offer any consulting on government compliance to our customers. We leave that to the expert consulting firms and simply do what testing is requested and, on occasion, make an informed recommendation as needed.

The majority of our testing is based around ingredient identity. In 2013, we began our new division of R&D testing where we offer method verification and validation for ingredients and actives in finished products. This is a topic of particular interest to the FDA as shown by recent 483s.

NIE: Do you help manufacturers develop testing methods so they can perform analysis in-house?

Lieberman: Celsis Rapid Detection systems are available for in-house use. As a primary screening assay, the Celsis system returns a clear, absence/presence result for microbial contamination.If there are no microbiological contaminants present, there is no further analysis required.

Rowe: Our labs hold a variety of accreditations, including ISO, HCEL, CALA and SCC. We are able to assist clients in developing, validating and implementing new test methods for their products for QA/QC, batch release testing, regulatory requirements and confirmation of novel manufacturing method or delivery matrices.

Sudberg: With our new R&D division, we now offer manufacturers method verification and validation for finished products. While a method may work, be verified or validated for a particular botanical or ingredient, the moment you add it to a mixture of other ingredients, that same method can no longer be utilized without a method validation or verification to show that the method is suitable, robust and fit for purpose.

NIE: What types of testing requests/services are growing more frequent and why?

Rowe: More clients are approaching NDI to perform real-time and accelerated stability testing, dissolution testing and product characterization for dietary supplements, natural health products and investigational new drugs.

Other services that have grown substantially over the past few years include our third-party testing and certification programs for fish oils, krill oils and fitness supplements. Our international fish oil standards program (IFOS) is recognized globally as the gold standard of certifications in this space. The IFOS testing standards are based on those set forth by the Council for Responsible Nutrition (CRN), the Global Organization for EPA and DHA Omega- 3 (GOED) and the World Health Organization (WHO), but made more stringent to create a higher level of quality in this space.

Lieberman: We are seeing an increased emphasis on product provenance and composition following years of highly visible recalls and investigations.Today’s savvy consumers expect their products to be free of contaminants and harmful substances. This has caused a number of companies to reevaluate their ingredients and preservative systems, to re-examine their release specifications and adopt a rapid detection system for faster product release.

With detection of contamination in just 24 hours, it is now feasible for companies to routinely screen their incoming raw materials for contamination prior to formulation. This data can then be used to monitor and compare suppliers’ ability to deliver purer, higher quality ingredients.

Similarly, adding a mould specification is now possible to do without delaying product release, as technology such as Celsis AMPiScreen reagents detect the presence or confirm the absence of bacteria, yeast and mould in just 24 hours.

Sudberg: We are always growing in cGMP ID tests as more companies become compliant. On increase are finished product method verifications and validations. Based on recent 483s, it is obvious the FDA is watching closely the finished product label claims.

NIE: What new testing services can companies utilize?

Rowe: We are launching a series of new certification programs over the year that will encompass a wide range of products including plant and algae products, botanicals and fitness supplements. Our new programs include GMO and banned substance testing in products.

Lieberman: Companies interested in adopting a rapid screening system can now have validation work performed by the Celsis application labs in Chicago, IL and Brussels, Belgium. This helps companies speed their implementation and start enjoying the financial benefits sooner.

Sudberg: We have a few new tests to present the industry later this year that will assist companies trading in extracts to determine the relative quantity of excipients or fillers in their products, as well as some simple ways to detect some problematic APIs (active pharmaceutical ingredients) found in raw materials.

NIE: How can your testing methods help manufacturers gain useful information to use in their marketing?

Rowe: The certification marks we offer in combination with our testing programs can be directly used on product packaging and marketing materials to increase the strength of a product’s marketing. We provide customers a detailed certificate of analysis upon testing which lists the analytical results.Companies that participate in our certification programs can choose to publish consumer reports on our website, which can be accessed by consumers at no charge. These reports allow companies to provide transparent testing results that consumers can use to compare products.

Sudberg: We believe that it’s high time to begin educating the final consumer on the quality control measures taken by a company. Making customers aware of the effort and expenses taken to ensure a high quality, safe product should be a value proposition pushed in marketing if you seek a decent ROI on your testing costs.

NIE: What are your clients’ most frequently asked questions?

Rowe: Our most frequently asked questions are how the test results we provide apply to our clients’ products. We help our clients interpret the results, especially in cases where clear regulatory guidance is not provided.

Lieberman: We have helped companies identify the raw material suppliers that are causing problems for their downstream quality testing and enabled them to bring clean product to market.

Sudberg: Our customer’s most frequently ask about cGMP ID testing or raw botanicals and extracts, as well as active ingredient quantification in raw materials and finished products.

Alkemists is a small niche lab with a small specialty in botanicals, vitamins and cosmetics. We don’t offer most of the lab tests the ‘the big labs’ do in an effort to focus on what we are known for and excel at. If you want metals, pesticides or microbiology tests, we can certainly facilitate the test with our partnerships with several choice labs we use.We are the experts in botanical ID and assays for actives and finished products.

NIE: Please discuss dry-labbing, and what finished product manufacturers should look for when choosing a testing method/testing lab.

Sudberg: Dry-labbing occurs when a report for analysis is generated without actually testing the material. It requires a typewriter and poor ethics and is not uncommon for some labs. Dateline exposed this with one particular lab, however, it is up to all of us to head over to our lab of choice for an audit.Any good lab should welcome an audit and be proud to showcase their quality systems. Lab notebooks should be accessible, calibration curves, instrument maintenance logs and training records, to say the least, should be readily available. There is nothing to hide if you are actually doing the work the right way.

Rowe: When choosing a lab to test your product with, make sure you choose a reputable, accredited facility. If possible, visit the laboratory and perform a site audit to become familiar with the laboratory’s processes and procedures.

Sudberg: Quality is in the hands of the manufacturer and each of us along the chain of custody of a product or ingredient.Trust, but verify is a rule we live by. Just because you have always purchased a product from a select vendor, doesn’t mean they haven’t been always shortchanging you. These are your assets on the line and ultimately the health of the end user we are all trying to please.