Quality Assurance and Compliance

Bocchi Laboratories consistently meets and exceeds the highest quality standards set and expected by our discerning and valued customers. Our state of the art laboratory and production capabilities include on-site microbiology testing, formula & packaging stability testing, production & packaging quality control, and analytical laboratories. Bocchi Labs is fully licensed by both USFDA and California State FDA as an OTC manufacturer and complies with standard Good Manufacturing Procedures (GMP). Our strict standards of quality and exacting auditing procedures are applied at every stage of the manufacturing process, from selection & receiving of raw materials to producing finished goods, guaranteeing our customers only the finest, high-quality finished products to meet their marketing needs and goals.

Our customers can be assured that their products will proceed from R&D to pilot batching, comprehensive regulatory review, extensive testing, and then on to full scale manufacturing with the optimum degree of attention, speed and efficiency offered by our expert staff. Constant quality control procedures extend from formula and product development, procurement of raw materials, stability testing, packaging management, full scale formula compounding, on through the entire filling and product finishing process.

TestingFrom the stringent control of all incoming materials, the meticulous record keeping, and the cataloging of retained samples, we maintain exacting quality control standards and procedures that permeate all operating processes from compounding to final deliveries. This results in excellent traceability of products and the continual ability to meet and often exceed our customer’s quality and performance expectations. In-house and independent labs are used for chemical analysis and quality testing to ensure that all quality parameters are met. Microbiological challenge tests are standard practice for all formulations. Laboratory staff monitors all batches for adherence to specifications in appearance, texture, color, pH, specific gravity, viscosity and microbiological integrity. Good Manufacturing Practices are met at all levels of the manufacturing process and a continuous improvement program is in place. In addition to a fully equipped microbiology laboratory, the following equipment is routinely used:

  • High Pressure Liquid Chromatographer
  • Infrared Spectrophotometer
  • Computerized Color Matching with Light Box Verification

Row_Tanks2Our High Standards of Cleanliness and Hygiene

The strictest levels of cleanliness and hygiene are observed by all of our staff in each and every area of production throughout our entire complex to guarantee the highest level of purity and quality in every product we produce. All facility equipment is scrupulously cleaned and sanitized after each and every use. You can always rest assured that the quality of your products will never waiver with Bocchi Laboratories.