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Specializing in FDA Regulatory Matters

Tips for Auditing a Contract Laboratory

Contract laboratories provide an extremely valuable and necessary service to the dietary supplement industry. The own-label distributor or manufacturer rarely has an in-house laboratory equipped with the appropriate scientific expertise to conduct all the testing required in 21 CFR 111, Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. However, a contract laboratory must be thoroughly scrutinized by the own-label distributor or manufacturer to ensure the laboratory complies with the applicable subparts of 21 CFR 111.

All personnel must possess the education, training, or experience needed to perform their job function in accordance with 21 CFR 111.12(c). Responsibilities and activities for each job function should be described in a formal job description. A comparison of the job description to on-the-job training provided in a personal training record as well as a resume or biography of several selected individuals should be examined during the audit to verify compliance with the regulatory requirements, but also ensure the laboratory has the scientific expertise to competently perform the desired tests.

The laboratory facility used to perform testing must be adequate per 21 CFR 111.310 and in accordance with 21 CFR 111.27, all equipment must be of appropriate design, construction, and workmanship to enable them to be suitable for their intended use. The latter is generally accomplished using an equipment qualification program. Documentation supporting the qualification of several different types of equipment should be reviewed during the audit. Part of the review must include an assessment of any software or electronic operations being performed by the instrumentation.

All electronic equipment and records must comply with the requirements dictated in 21 CFR 11, Electronic Records, Electronic Signatures. Equipment must then be calibrated and maintained at a frequency dictated by the manufacturer to maintain accuracy and precision and these activities must be documented in equipment log books as governed by 21 CFR 111.35(b)(3).

All laboratory controlled processes, including written procedures for test methods, must be developed and implemented in the laboratory as required by 21 CFR 111.325. There must be evidence that these test methods are being conducted, as written, by laboratory personnel and that this is documented at the time of performance. The documentation must be thorough and detailed and include the performance of each step of the method. Test methods employed must be scientifically valid as required by 21 CFR 111.75(h)(1) and 111.320(b).

The FDA described a scientifically valid test method as one that is accurate, precise, specific for its intended purpose, and consistently does what it is intended to do (rugged). Documentation that a method meets these criteria is accomplished from method validation studies for the sample matrix via experimentation, peer-reviewed literature, or compendial sources. Several examples of such documentation should be reviewed by the auditor.

Other critical laboratory controlled processes to examine during a contract laboratory audit include those for out of specification (OOS) investigations, deviations, and corrective and preventative actions. These situations are inevitable and a strong quality system must be in place for handling them.

There are many important aspects to choosing a contract laboratory, from assessing testing and record-keeping to confirming it is equipped and suitable for its intended use. A pre-audit of a contract laboratory helps to ensure that their procedures match those required by FDA as well as your own internal requirements. This up-front work will go a long way towards finding the right partnership to enable distributors and manufacturers to market safe products.