Physicians’ Select Herbal Supplements offers only formulations that have been derived from a multitude of laboratory tests and clinical studies along with advise from our extensive staff of physicians, herbal specialist, PhD’s, pharmacists, and chemists. All of our raw materials must pass stringent quality controls before they are utilized. In addition, we use only those precursor materials that are of the highest quality that pass our in house quality inspection.

Our facility has been in operation for over seventeen years manufacturing dietary supplements, natural foods, personal health care products and over the counter medications. We are one of the few manufacturing facilities that adhere to the following criteria:

• Manufacturer policies and quality assurance/quality assessment protocols strictly adhere to the Good Manufacturing Practices (GMP).
   
• All raw materials are tested for authenticity by our in house laboratory prior to the use in any of our products

The manufacturing facility was designed specifically to manufacture products from the receipt of raw material to the final shipping of the finished supplement. Each area of the manufacturing facility organized to prevent confusion and/or mistakes during the production process.

The manufacturing facility has the following specific areas allocated for the production process:

• Specific receiving and quarantine area
• Warehouse for the storage of raw materials
• Quality control laboratory
• Separate pharmacy for blending and formulating of products
• Staging area for the holding of material in the middle of production
• Specific production area for the various manufacturing processes including: forming tablets, encapsulation, powders and liquids
• Labeling and packaging area
• Climate controlled area for the storage of the finished product

The facility also adheres to strict sanitation protocols to ensure that the building is exceptionally clean and free from insects and rodents. All of the blending, compounding, tablet forming, encapsulation, powder and liquid manufacturing areas have state of the art air circulation systems to prevent excessive dust accumulation, contamination by microorganisms or cross ventilation.

Quality Control

All raw materials are tested for purity prior to production. Quality control engineers have the authority to reject any product during any stage of production that does not adhere to our strict quality standards. All personnel follow explicit written protocols that are strictly enforced during the manufacturing process. All steps during the manufacturing process are documented and reviewed by quality control specialist. Manufacturing equipment is properly maintained and cleaned on a predetermined schedule which is documented in company logs for review by the Department of Agriculture. This helps to ensure the absence of any contamination during the manufacturing process. Production records associated with each unit of a product including all raw materials used are filed for two years past the expiration date.

Further quality control is demonstrated in the following manner:

• Product analysis - is recorded for each product that is manufactured. This analysis contains the specific components of the herbal product including a lot number for each of the ingredients and the productions methods used.
  
• Raw materials - are purchased only from reputable wholesalers. Each raw material in our products must come with a Certificate of Analysis provided obtained from the supplier. Our in house quality assurance team also analyzes the raw materials for authenticity.
  
• Packaging material - all packaging materials are purchased only from reputable wholesalers. Specific quality assurance personal ensure that all labels are assigned to the proper products manufactured to avoid any confusion. All new labels are cross checked with the original master label to ensure there has been no mistakes during the printing process.
  
• Lot Numbers - once an order request has been received the herbal supplement to be manufactured is entered in the production records and a lot number is assigned. The raw materials are subsequently released to the pharmacy once all products have been checked for authenticity.

Manufacturing Guidelines

In addition to the above outlined protocols for the physical aspect of the manufacturing facility. Physicians' Select Herbal Supplements also adheres to the following manufacturing guidelines to ensure the utmost quality control:

• Pharmacy - after the raw materials have been released to the pharmacy, they are positioned in carefully designated areas. Raw materials are again checked by the director of operations prior to use. A log book is then initiated for each new batch carefully noting all procedures and lot numbers of raw materials consumed in the manufacturing process. Careful attention is given to all pharmacy scales and additional equipment to insure proper measuring without contamination.
  
• Blending and Granulation - all equipment used for in the process of mixing and granulation are inspected by the director of operations prior to use. Raw materials are then inspected for the final time and the lots are then processed using the strict written guidelines for each herbal product. Following granulation and blending the powder blends are stored in specifically designed containers to ensure freshness and to avoid any contamination. Once again the director of operations ensures that all new blends are labeled appropriately.
  
• Encapsulation and Compression – all equipment used for in the process of mixing and granulation are inspected by the director of operations prior to use. Raw materials are then inspected for the final time and the lots are then processed using the strict written guidelines for each herbal product. Once a test unit has been processed a sample is unit is issued to quality assurance to be compared to retained samples insure product integrity. Once the new unit has been approved by quality assurance the full line production may begin. Quality assurance inspections are conducted using set protocols for the capsules. As with the blending and granulation process the capsules are stored in specifically designed containers to ensure freshness and to avoid any contamination. The director of operations ensures that all new capsules are labeled appropriately.
  
• Liquids - follow the same stringent protocol as the the above mentioned blending, granulation, encapsulation and compression procedures.
  
• Packaging and Inspection - upon completion of the processing, the final product is inspected again by the quality control staff, broken tablets, over filled capsules, and other defective finished products are removed from the lot. Products released by the quality control staff are subsequently either packaged for bulk storage or bottled and labeled for consumer use (labels contain the appropriate information as required by the Federal Drug Administration, batch numbers are logged). All finished products are properly labeled and closed with a tamper proof seal. The quality control unit also retains samples of raw materials (for one year past the expiration date of the last product they are used in) and finished products (for one year past the product expiration date) are maintained under control conditions. All of our liquid products follow the same stringent control standards were applicable.
  
• Final Products - all final products are stored in quarantine in a climate controlled environment until final delivery to the customer.

All of Physicians' Select Herbal Supplements are manufactured using Good Manufacturing Practices set forth by the Federal Drug Administration. In addition, both scheduled and surprise inspections by the quality control staff during different aspects of the manufacturing process help to ensure specific quality, strength and purity for both the raw materials and the finished supplements.

If you should have any questions or suggestions concerning the information mentioned above please feel free to contact us.