Madre Labs® ~ Quality Assurance
1. RAW MATERIAL SOURCING
Our raw materials are selected exclusively on the basis of quality & efficacy (the science), and not on the basis of cost. We rely on reputable industry suppliers and frequently use “Branded” ingredients. All of our suppliers are required to perform rigorous analytical tests, including, but not limited to the following analyses: Material Identification, Heavy Metals, Microbial, Pesticide Residue and Organic Volatile Impurities (OVI). We require Certificates of Analysis, Specification Sheets, Material Safety Data Sheets and Testing Results from the most sophisticated analytical methods (such as: HPLC, HPTLC, GC, UV-VIS, FTIR, NIR and ICP-MS) to ensure the highest quality finished products. We also do our own third-party testing to confirm the results of our suppliers’ tests.
2. CONTRACT MANUFACTURING
Madre Labs® employs several of the Industry’s top Contract Manufacturers to blend and package our Premium, Innovative products. Our Contract Manufacturers have successfully completed multiple third-party quality audits, thus gaining recognition for meeting the highest standards of quality. These companies received their Pharmaceutical Drug Manufacturing Licenses from the California State Health Department (Food & Drug Branch), are cGMP Certified (registered) by the Natural Products Association (NPA) and NSF International.
a. Receipt of Incoming Materials
All raw materials, components, packaging and labeling materials are received through the same controlled entrance into our contract-manufacturer’s facility; and are thoroughly checked, counted, and identified by trained personnel before being allowed into the Quarantined area.
b. Quarantine & Release
All raw materials, components, packaging and labeling materials are held in the Quarantine area until sampled, tested, examined and released for use by the Quality Control department. Sampling is performed according to written Standard Operating Procedures (SOPs) designed to prevent contamination of raw materials, components and packaging materials. When the samples have been received, Quality Control personnel perform the specific test procedures, document the results and match them against all specifications. All raw materials, components, packaging and labeling materials which pass inspection will receive a Release sticker. Only containers bearing this Release sticker are allowed out of Quarantine and into the main warehouse.
The first step of the manufacturing process involves weighing the raw materials, precisely as indicated on the Master Batch Production Record. Each raw material is identified by its name and code number, and then weighed using a calibrated scale. The material is then placed into a clean, properly labeled container, indicating: raw material, weight, product name, code, and lot number. A complete double-check is performed, to ensure that the information is correct and matches the requirements of the Master Batch Production Record. After weighing all the raw materials for a production batch, all documentation is rechecked and signed by qualified technicians before sending all materials to the Compounding/Blending department.
It is critical to prevent all Contamination or Cross-Contamination of raw materials. Each processing room is fully equipped with an advanced airflow system designed to minimize the chances of cross-contamination. Technicians identify each of the weighed raw materials and compare them to the requirements of the Master Batch Production Record. As each procedure is performed, the material compounder documents that the step has been completed, and then a second technician verifies and documents that. As each raw material is added to the batch, the material compounder documents the addition, and a second technician verifies it. Once all compounding steps are complete, the uniform blend is discharged into poly-lined, “in-process,” labeled containers. Samples are taken according to written SOPs. The Master Batch Production Record is reviewed and submitted to the Quality Control department along with the samples for “in-process” testing to assure that the proper specifications have been achieved.
e. Filling & Packaging
The Packaging department consists of two divisions: 1. Bottle filling (counting & filling of unit dose forms such as tablets, hard-shell capsules, and soft-gel capsules) 2. Powder filling: packaging of powder blends, such as drink mixes. Both areas are controlled by written SOPs, designed to assure the proper fill, components and labeling for each packaging run. The Packaging Record provides all the necessary specifications and allows for full documentation of the packaging phase. The Packaging Record then becomes part of the Master Batch Production Record, which allows all processing and packaging information to be filed in the Document Control department. Packaging runs are monitored to ensure that the final product meets all specifications. At the end of the packaging run, the Packaging Record and finished samples are submitted to the Quality Control department for final analysis & testing prior to release for shipping.
f. Overview of Quality Control (QC) & Quality Assurance (QA)
The Quality Control Department performs all required tests and assays on raw materials, in-process goods and finished products, according to cGMP regulations. All test specifications, standards, sampling plans, procedures and other laboratory control methods are continually reviewed and approved by the Quality Control Department. Independent, third-party labs are regularly used to assure quality compliance. The Quality Assurance department cross-checks all stages of the manufacturing process for compliance with written Standard Operating Procedures. The Quality Assurance group routinely conducts in-house audits to ensure conformity to cGMP requirements and the effective operation of the total system. Lab procedures, methods and instrument calibration protocols are also monitored for accuracy, precision and reproducibility. Finished products are only released after the final inspection has been completed by the QA Department in accordance with written SOPs.