Quality Assurance
ProTab manufacturing operation is fully compliant with all current Good Manufacturing Practices (cGMP 21 CFR Part 111) established within the industry and meets or exceeds all quality standards for Nutritional Supplements. ProTab has established Standard Operating Procedures (SOP’s) to ensure that this standard is met in all phases of the manufacturing process. ProTab Labs manufacturing process is consistent with NSF/ANSI 173, USP-NF for Dietary Supplements and in accordance with FDA guidelines.
Analytical Support – ProTab provides
All raw material is tested prior to manufacturing to ensure that the product specifications are met and no microbiological growth is detected.
Standard Quality Control Procedures dictate that all specifications are multiple checked by the technicians and QC for each phase within the manufacturing process.
In addition, Tablets and Capsules are tested for Disintegration and Dissolution to ensure that they are within approved USP standards.
All batches of finished goods are tested at the completion of manufacturing to ensure that all product specifications are met.
Certificate of Analysis (CofA) are provided with each batch produced, verifying that all product specifications are met.
ProTab GMP manufacturing
operations include
Isolated Rooms for each phase of the manufacturing operation. These rooms allow for higher degree of quality checks, sanitation and prevents cross contamination of material within the manufacturing process.
All manufacturing equipment and contact surfaces are stainless steel to maintain efficient and thorough cleaning standards.
Each room’s floors are specially coated and floorboards and wall coverings are designed to provide for efficient and thorough maintenance of the cleaning standards.
A Specialized Dust Collection system is in place to prevent migration of material from one workstation to another as well as helping ensure that we meet our SOP’s for cleanliness and sanitation.