Life Extension^® Quality Assurance / Quality Control

All of the products formulated by Life Extension are produced in accordance with Good Manufacturing Practice (or GMP) as set forth in 21 CFR Part 111 of the Food Drug and Cosmetics act. Manufacturing facilities are periodically inspected by either the Food and Drug Administration, or the United States Department of Agriculture. Facilities are inspected for their adherence to Standard Operating Procedures, employee training, product specifications and supplier/vendor qualification procedures. In addition, Life Extension performs periodic audits of manufacturers to ensure adherence to all regulatory requirements. Life Extension ensures that manufacturing Standard Operating Procedures (SOPs) are followed to ensure consistent product quality.

Raw Materials

Product specification begins with the ingredients we qualify for use in our formulas. We evaluate the source data for these ingredients from well-established vendors with impeccable credentials when formulating our products. Working with high-quality, raw material suppliers allows us the opportunity to select the best options for product formulations.

All sourced raw materials and raw material vendors undergo an extensive qualification process by our highly experienced members of our Product Development, Quality Assurance, Quality Control and Purchasing departments. All raw materials are evaluated according to our internal Raw Material Qualification Standard Operating Procedure (SOP). Qualification must be approved at multiple steps in the process for each raw material to meet our stringent identity, purity and potency requirements before a material is approved for use.

Once approved and purchased, all raw materials are received and placed “on hold,” pending release by Quality Control. Release by our Quality Control department occurs only after samples of each lot of raw material passes evaluation according to the raw material specification criteria. Testing includes, but is not limited to, chemical identification [using Fourier transform infrared spectrophotometry (FTIR), ultra-violet (UV) or high performance thin layer chromatography (HPTLC)], physical characteristics, potency/strength confirmation, microbial analysis and other contaminants including heavy metals to verify and approve the Certificate of Analysis (COA) for each material. Complete COAs that meet our specifications are mandatory for every lot that is received for use in production. Material can only be released into inventory once it meets the applicable specifications. If materials do not meet our specifications at any step in the process, they are rejected and returned to the material supplier.

GMP (Good Manufacturing Practice) Production

Master production documents (also referred to as Master Manufacturing Records) are approved by Quality Control personnel and are kept on file at our manufacturing facilities. They are created from our Finished Product Specification Packets which are on file at Life Extension for every product under our brand.

Batch sheets (which are part of the master production documents) list all of the ingredients and the required quantity necessary to produce one batch of product. Each lot number of ingredient, and amount weighed, are recorded on the batch record for traceability. Initials are required by the individual who measured the materials as well as a second individual responsible for review and verification to ensure accuracy. Additional checks and balances follow, including separate QC inspection processes to ensure consistent product quality.

Weighed ingredients are transferred to the blending department. Material is blended to maintain consistency and continues throughout the specific production process dependant on type of finished product {e.g., softgels, encapsulated hard gelatin (or vegetarian) capsules, tablets, etc.}.

In-process controls throughout production processes include line clearance (all production equipment that comes in contact with product must be cleaned according to mandated procedures between all production runs and verified to ensure sanitation has been performed prior to use), lot code verification, weight checks, label and material checks – all of which are performed according to written procedures. Product samples are collected at different stages of production for appropriate chemical and microbiological testing as per the product specifications.

The finished product is transferred to the packaging department, where empty packaging bottles are filled, sealed, labeled, stamped with a lot code and ‘use by’ date, put in cases, and stacked on pallets. Our packaging is designed to protect the integrity of the product and ensure the freshness of the product throughout its shelf life.

The finished product is placed on hold until Quality Control completes additional evaluation to ensure adherence to all SOPs. This includes review of the completed batch record and all pertinent tests required on the product specification. This ensures that all specifications set within the production process are accurate and within pre-defined parameters. After the evaluation has been completed, and the product has passed all requirements, the test results are indicated on the Certificate of Analysis (COA) and the product is released. These COAs are maintained on file for each production batch received at Life Extension and are available upon request.

Life Extension Product Labels

Product labels go through a comprehensive review and approval process. Labels comply with all applicable laws and regulations, and are periodically updated based upon the most recent nutritional science parameters for active ingredients. All necessary information is clearly indicated on all our product labels, as well as any pertinent allergen information.

Label storage is tightly controlled with limited access to only authorized personnel. All labeling is checked when initially received for physical size, color variation, wrinkles, condition, and copy versus approved sample. Quality Control personnel are authorized to approve or reject labels per our internal SOP. All labeling is counted and verified upon issuance and on returns for reconciliation purposes.

Finished Product Analysis

Each manufactured lot of finished product is tested using state-of-the-art testing equipment to ensure finished product quality, purity and potency. Testing includes, but is not limited to, chemical analysis by high performance liquid chromatography (HPLC), ultraviolet/visible spectrophotometry (UV-Vis), gas chromatography (GC), and gas chromatography mass spectroscopy (GCMS). Physical analysis is performed and active ingredients claimed on the product label are confirmed. Microbiological analysis and heavy metal testing (by ICP-MS) is also completed on every production batch to ensure that all specifications are met.

Complete COAs that meet specifications are mandatory for every production lot of product that is shipped to our customers.

When inspection and testing is performed, Quality Control personnel are authorized to approve or reject product if the finished product does not meet established quality guidelines at any step in the process. Only if the finished product meets specification is the product released for shipment.