Advantages of a Contract Manufacturer Using an Independent Lab

Testing is a critical aspect of manufacturing dietary supplements, homeopathics and over the counter (OTC) drug products. Adherence to strict cGMP (current good manufacturing practice) guidelines by both a CMO (contract manufacturing organization) and its chosen testing laboratory are crucial for a products quality and safety.

Testing raw materials as well as product at various stages of manufacturing is time- and labor-intensive, and can be costly. Many CMOs find outsourcing testing to a contract laboratory to be more advantageous than performing all testing in-house. When choosing a CMO, a supplement brand owner should be sure the contractor has the contacts and agreements with contract laboratories that fit the testing needs of its product. The advantages of outsourced testing, independent of the contract manufacturing facility, include increased credibility of the results, additional testing capacity, the use of secondary testing facilities in case of extreme weather or disasters, focused expertise and cost management.

FDA Testing Requirements

Both manufacturers as well as the independent laboratories are required to comply with FDA cGMP guidelines, undergo inspections and perform sufficient testing to assure product quality and safety. Materials and products must be high quality, consistent, accurately labeled and free from impurities. Manufacturers must comply with testing requirements, including the evaluation of the identity and strength of raw materials as well as finished products. In addition, assurance must be provided that all materials and products are free from microbial contamination.

Laboratory testing can include fairly basic observations, such as appearance, color, odor, specific gravity, pH and viscosity. More advanced analytical evaluations may require sophisticated equipment or more complex testing procedures. No matter the test, laboratories must follow cGMPs.

A CMO may chose to do some basic testing in-house, but outsource more involved testing, such as finished product assay analysis. Regardless of the amount of outsourced testing, the brand owner and CMO are responsible for proving the laboratory data's accuracy by verifying results. Verification of laboratory results is generally accomplished by the CMO.

Credibility

One major advantage of using an independent laboratory is the testing is considered unbiased. There is less chance of business pressures influencing the outcome. This perception can be advantageous from a quality assurance (QA) perspective as well as for the brand owner and CMO as a whole. It is the responsibility of your CMO to thoroughly choose and qualify only competent, reputable laboratories that have the capability and knowledge to perform the proper tests, follow FDA regulations and requirements, and have appropriate testing equipment that is well maintained.

Capacity and Timing

Using multiple, independent laboratories can eliminate testing backlog issues, which may improve product delivery timing. Keeping all testing in-house can give you tighter control over scheduling, but high-volume demands on your laboratory may require project triaging, which can cause delays. Do you or your CMO have the capacity to handle overflows?

Another factor to consider is how severe weather events or other unforeseen emergencies can shut down your in-house or outsourced laboratory. The ability to rely on multiple outsourced laboratories in an emergency situation can help prevent scheduling backlogs and prevent delay in releasing product.

Expertise

It may make sense for your CMO to conduct some basic testing in-house, but outsource other types of testing. For example, the CMO may want to perform some in-house testing if its laboratory has particular expertise and capacity, but outsource those requiring more sophisticated processes and equipment. The extensive amount of expertise needed as well as the amount of equipment required to perform a vast array of testing for each brand owner can be daunting to a manufacturer, particularly to a smaller CMO. This is yet another reason why smaller CMOs outsource testingto assure a high level of expertise while still keeping down overall costs.

Cost

Outsourcing laboratory services relieves a brand owner of the in-house financial burden of testing, including the high cost of capital investment needed to establish an in-house testing laboratory. For highly sophisticated testing, the initial capital investment for a fully equipped in-house laboratory that can accommodate all testing needs can be exorbitant when considering costs for adequate infrastructure, state-of-the-art equipment and controls. Additional overhead costs will also include equipment upgrades, regular calibration and maintenance, and liability insurance, to name a few.

Manufacturers making products across a broad range of FDA-regulated classes will need a broad range of equipment, specialized expertise, additional staff and personnel training. By outsourcing testing, fewer scientists and lab technicians are needed thus reducing hiring, training, payroll and benefits costs. In addition, the need for large monetary investments in specialized testing equipment will be eliminated, allowing the expenditures to be utilized in the CMOs manufacturing facility, often resulting in a more competitive business.

Quality

When selecting testing laboratories, manufacturers should check whether they offer the scope of services needed and have the capacity and expertise to fulfill their requirements. They should check the laboratories reputation for quality, whether it has a QA program, the credibility of its scientific practices, methods used, pricing and the level of customer service the laboratory can provide. Diligence in finding the best outsourced laboratory available is vital to successfully manufacturing quality products no matter the regulatory class.

High-level CMOs are committed to providing high-quality services, meeting clients expectations and cGMP requirements, and maintaining a favorable reputation. Outsourcing enables the CMO to focus on core competencies without sacrificing quality.

Rebecca Klein is the Internal Quality Consultant at P.J. Noyes (pjnoyes.com). She has more than 20 years of experience working in pharmaceutical quality, R&D and scientific research. For contract manufacturing inquiries, email [email protected].