Contract Manufacturer

Good Manufacturing Practices at Vesta Pharmaceuticals, Inc.

Vesta's manufacturing procedures are based on the United States Food and Drug Administration recommendations, as published in the United States Pharmacopea 23 "<2750> Manufacturing Practices for Nutritional Supplements." Written Standard Operating Procedures are followed at all times.

Organization and Personnel
The Quality Control Department has adequate facilities and trained personnel for the testing and approval (or rejection) of all components and packaging materials. All responsibilities and procedures are listed in writing. The department is supervised by a Ph.D. Organic Chemist with eight years experience in the pharmaceutical and medical device industry. All personnel, including supervisors, engaged in the manufacture of a nutritional or pharmaceutical product have the proper education and training needed to perform the assigned functions. Written Vesta regulations assure that all personnel maintain proper dress and good personal sanitation and health habits. Protective apparel is always worn; this includes head and hand covers to protect products from contamination.

Buildings and Facilities
All facilities used in the manufacture of a nutritional or pharmaceutical product are designed for easy cleaning, segregation of raw materials and components, proper management of in-process materials, and storage of finished products under controlled conditions. Lighting, ventilation, and other environmental controls are designed to facilitate the manufacturing process and eliminate contamination. Buildings are kept in a sanitary condition and all plumbing, washing, and toilet facilities are maintained in good repair. Sewage and refuse are removed at appropriate intervals and undergo proper disposal procedures.

Equipment
All equipment used in the manufacture of a nutritional or pharmaceutical product is of appropriate design, adequate size, and suitable location as to facilitate operations for its intended use, cleaning, and maintenance. Materials used in formulation, especially contact surfaces, are made of materials that will not react with or contaminate in-process materials, and they are made of materials that are easily cleaned. Equipment and utensils are cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination. The written directions for these procedures are carefully followed and documented.

Components, Product Containers and Closures
All raw materials and packaging materials are documented upon receipt and assigned a unique identifying number. The materials are quarantined until tested and released by the QC Dept. The written procedures describing the proper handling of these materials are carefully followed. All raw materials and packaging materials are tested or examined for identity, conformity, purity, and strength by the QC Dept. according to written tests and procedures. Materials failing these tests are quarantined until proper disposal. Raw materials and packaging materials are re-tested at suitable intervals to assure that they meet the original written specifications for purity, etc.

Production and Process Controls
Appropriate written procedures (Batch Records, Analytical Methods, etc.) are followed carefully during the manufacturing and in-process testing of the nutritional and pharmaceutical products. These procedures are drafted, reviewed, and approved by the Research and Development and Production Departments, and they are given final approval by the Quality Control Department. Finished documents are reviewed and approved by the QC Dept. before release of the finished product by the Production Manager.

Labeling and Packaging
Written procedures are provided describing, in sufficient detail, the receipt, identification, storage, handling, sampling, examination, and/or testing of labeling and packaging materials. These procedures are carefully followed, especially with regard to the control of labeling materials. Gang printing of labels is never used. Label quantities are reconciled and labels are carefully examined for identity and conformity to the labeling specified in the master or batch production records. Tamper-resistant packaging is used for all nutritional and pharmaceutical products. Child resistant caps are used whenever appropriate or required.

Holding and Distribution
Raw materials and finished products are stored under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity of the products are not affected. The oldest approved stock of a product is distributed first. The distribution of each lot of product is carefully documented.

Laboratory Controls
Analytical methods and laboratory apparatus are validated to ensure that the results obtained are appropriate, accurate, and precise. All instruments used in the production or testing of nutritional and pharmaceutical products are calibrated at suitable intervals in accordance to written procedures to ensure their reliability. All testing data is recorded when collected in bound laboratory notebooks. Reserve samples of raw materials and finished products are retained and stored under appropriate conditions.

Records and Reports
Master Production and Control Records for each product are prepared and maintained. Changes to these documents are made only in conformance with written Change Control Procedures. Care is taken that only the most recent approved version of a document is accessible to production and QC personnel. Batch production and control records are prepared for each batch of product and include complete information relating to the production and control of each batch. At each stage of production or testing, the technician performing the operation initials and dates each charge-in or other procedure. A second technician checks the weight or procedure and also initials the record. A complaint file is maintained containing copies of complaints, the nature and results of any investigation, and any follow-up actions taken. A written procedure governs the handling of all complaints. Any deviation from the batch record conditions or procedures, or any situation that would be expected to affect the quality, etc. of raw or in-process materials, or finished products is made the subject of an Incident Report. An investigation by the QC Dept. is made to determine if the deviation will have an effect on the material involved. The approval of the QC Dept. is required before manufacturing can continue.