Our Quality Department is involved in all aspects of our business at Protec Laboratories. You will find it as part of product development, incoming inspections, documentation – every step from conceptualization to the final review and release of all our finished products.
The Quality Department has a combined experience of over 125 years, including degreed scientists in executive leadership roles. The Quality Management System at ProTec Laboratories is a comprehensive quality program designed to meet and exceed the cGMP requirements set forth in Title 21 of the CFR for parts 211, 110 and 111.
At ProTec , our facilities are designed to enable the proper flow of incoming materials and outgoing finished products. Whether raw materials or packaging are supplied by our customers or purchased by ProTec, all incoming materials receive the same attention. All materials must be vigorously inspected, approved and released by our Quality Department before they are moved into our warehouse. Every incoming material (raw material, packaging, labeling, etc) and finished product is assigned a unique control number. This ProTec lot number control system gives us the ability to ensure each item we use can be traced back to its origin.
An integral part of our comprehensive quality management system is our in-house quality control testing laboratory. It is here that the quality oversight of all raw and bulk in-process material occurs. The evaluation of these items by our quality team ensures that our finished products exceed your expectations. Our quality team reviews and identifies all raw materials against quality specifications prior to use to ensure only the best materials are used for your products. Raw material testing can range from identity testing using our FTIR spectrometer, to organoleptic analysis, to our own robust certificate of analysis verification program.
During bulk product evaluation, we utilize a range of industry accepted quality testing criteria including color, texture, odor, specific gravity, PH, brix, viscosity, taste and analytical testing every day to confirm quality is met for all products. Bulk product testing against quality standards and predetermined unique to formula specifications allow us to confirm what we make meets your expectations every time. Our quality group enables this by ensuring that all bulk material is reviewed and approved before filling and packaging only if the material conforms to our quality standards.
The water used during manufacturing of all aqueous products at ProTec is processed by a DI-RO system. This water system has been validated to USP 35 for Purified Water. The water system is monitored daily and tested weekly for adherence to USP requirements.
Quality verifications are performed from the beginning to the end of our processes. Quality monitoring, inspections and verifications are embedded throughout our distribution, manufacturing, filling and assembly processes. The inspection and verification of both intermediate and finished products by the quality team to ensure conformance with predetermined specifications is performed for all products we manufacture. During manufacturing, our production suites are manned by qualified quality inspectors that have been cross trained to perform line clearances, confirm line set ups, verify fill levels, lot number placement and legibility, label revisions, manual and seal integrity, vacuum chamber testing, torque criteria, etc. for the variety of dietary supplements, drinks, and personal care/OTC products we manufacture. Once your product is packaged, the finished product will be held in a separate shipping area for post packaging awaiting microbial clearance from the quality department. All microbiological and analytical testing is submitted to approved off-site contract laboratories for testing. Testing data can then be used to generate a unique certificate of analysis for each product which can be submitted to you ensuring knowledge that the product met its specifications and cGMP requirements.
In distribution, we possess the capabilities to ship directly to customer requested locations in more than 90 countries around the world. All shipments are securely wrapped and palletized. We also can prepare international container shipments to facilitate exportation. Aerosols are subject to DOT testing to meet shipping requirements.
Separate cold storage areas are available on-site for your needs. Each area is monitored daily to assure our temperature and humidity levels are appropriately maintained. If needed, we can also make use of larger third-party cold storage facilities when necessary.
Pro Tec also manages a robust retention program for all aspects of our business. Reserve samples are kept on site for all raw materials, packaging, bulk and finished products. Our quality group also manages and maintains an archive program for all documentation associated with each batch manufactured for you. In addition, we have resources available to help support your stability needs.
Various products manufactured at ProTec carry the following certifications:
- QAI – Quality Assurance International
- QCS – Quality Certification Services
- Kosher certifications
- Halal certifications
- ICMAD – Independent Cosmetic Manufactures and Distributors
In addition to our commitment to producing high quality products, we also provide compliance and regulatory affairs support. We have a compliant document control process which enables us to manage the archived documentation required to meet industry requirements. We have Standard Operating Procedures that have been implemented to address all critical areas.
Our robust regulatory affairs team is available to support your growth into new domestic and international markets. We can also provide assistance with a marketing regulatory strategy that is compliant with industry standards. Our experienced staff has the resources to assist you with:
- Personal care (cosmetic and OTC) regulatory support
- Dietary supplement regulatory support
- International regulatory and label law compliance
- Health Canada (QARs, Site Licenses, PIAFs)
- Certificates of Free Sale
- Certificates of Origin
- Domestic and International Protein Certificates of Export
- EU regulation support
- Halal certifications
- Organic certifications
- Kosher certifications
- Aloe (IASC) certifications
With over 30 years of experience, our Regulatory team has the resources at hand to support your needs for the varied product categories manufactured at Pro Tec.