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Vitalabs, Inc All products are manufactured under the guidelines of the U.S. Food and Drug Administration. This includes more than 500 different formulations sold in both domestic and international markets.
The following overview reflects the procedures followed for the manufacturing of each and every product offered by Vitalabs.
Organization and Personnel Back to top The company is structured so as to provide all necessary measures and controls for the manufacture of products of the highest quality, which meet safety requirements and possess the identity and strength that they are intended to possess. An adequate number of qualified personnel is assigned to perform and supervise the manufacture of nutritional products, and employees are trained according to current good manufacturing practices in the operation they are to perform. Standard Operating Procedures (SOPs) are strictly followed in each step of the operation. A quality control unit has been established which consists of the President, the Director of Quality Assurance and the Quality Control Manager. This group is responsible for the approval or rejection of all components used in the manufacture of a product, review of production records and approval or rejection of finished products. The quality control unit is also responsible for approval of procedures and specifications that affect the production and quality of nutritional products. A quality control laboratory is available which is fully equipped for testing of raw materials and finished products according to set specifications. Retain samples of raw materials and finished products are maintained in this laboratory for pre-established periods of time.
Building and Facilities Back to top The manufacturing area is designed to facilitate the operation from the time of receipt of raw materials to the time of shipping of the finished product. The areas are organized in a manner to prevent mix-ups and contamination of raw materials, packaging components and the products manufactured. The areas allocated to different operations are as follows: a. Receiving and quarantine
area Adequate lighting and ventilation is provided throughout the building and sanitation procedures are in place to ensure the building is maintained clean, and free of rodents and other vermin. All manufacturing areas including storage of finished products are air-conditioned. Individual dust collection units service the areas of pharmacy and blending tableting, encapsulation and coating, in order to prevent build up of dust and microorganisms, and product contamination. Separate rooms and/or cubicles are employed for the performance of specific operations which are equipped with appropriate equipment and separate air handling systems using negative air pressure for the prevention of cross-contamination.
Written procedures are strictly followed in production of nutritional products to ensure their identity, strength, quality and purity. In process controls have been established to assure that the product is made reproducibly and according to set specifications. Process control functions are documented at the time of performance and processing records are maintained throughout the manufacturing process. Equipment used in the manufacture of a product are properly maintained and thoroughly cleaned according to written procedures to prevent malfunction and contamination of the product. Procedures are in place for cleaning, setup and operation of equipment, as well as its inspection prior to use. A log of use, cleaning and maintenance is kept for each processing equipment. To ensure batch uniformity and integrity of the product, procedures have been established for in process testing. These control procedures include, where appropriate: 1. Appearance In process specifications are consistent with finished product specifications. The quality control unit may reject a product at any stage of the manufacturing process, if the purity or quality of the product is compromised. Rejected products are quarantined until an investigation of the problem is completed.
All production and analytical records associated with a batch of a product are retained for at least one year past the expiration date of the batch. Records are also maintained for all raw materials and other components for at least one year after the expiration date of the last lot of product incorporating any of these materials or components. 1. Raw Materials: Raw materials and packaging components are purchased from reputable suppliers. A Certificate of Analysis is obtained from the supplier which is maintained by the Quality Assurance group for at least one year past the expiration date of the product. All raw materials received are identified and checked for their physical characteristics, and identified according to the supplier label claims and the purchasing department. An inventory card is generated for each lot of material which is used by pharmacy to maintain a log of material use. Samples are withdrawn and submitted to Quality Control for testing according to specifications and Standard Operating Procedures (SOP's) 2. Packaging Components and Labels: Containers, closures, cotton, seals and polyethylene bags are obtained from reputable suppliers and physically checked upon arrival for quality and specifications, using statistical sampling. Customer's labels are checked against the master label, kept in locked cabinets, and are issued in product labeling operation under strict controls. Inventory cards for packaging components and labels are maintained by the packaging group. 3. Master Formula: A master formula, along with a product number, is issued for each product. The formula contains the name and strength of the product, product specifications, ingredients and the quantities to the used, as well as manufacturing instructions. The master production records also provide for recording the lot number of each material used, weight checks, the date(s) of manufacturing and production yield. 4. Lot Number and Batch Size: Upon receipt of an order, the product to be manufactured is entered in the master production book and a lot number is assigned according to standard operating procedures. The lot number consists of seven digits. The first three digits identify the month and year (i.e. 055 for May 1995), followed by three digits for sequential identification of receipt of orders. The seventh digit is usually a one and is reserved for designation of sublots (i,e. 1,2,3…etc.) within the same batch order. A complete lot number for example would 055-0120. The size of each batch is determined by the production personnel according to the size of equipment to be used. Each lot, or sublot thereof, is manufactured and tested under essentially the same conditions. Representatives retain samples and the manufacturing records are maintained for a minimum of one year past the expiration date of the product. 5.Issuing of Batches: Upon receipt of an order, a lot number is assigned and batch folders are issued by the planning group. The batch folders include the formula, manufacturing instructions and all in process control records to be used during manufacturing. Upon scheduling, the batch records are forwarded to the Director of Operations who releases them to Pharmacy. All manufacturing records are filed according to product number and lot number, and maintained by the Directory of Operations.
Manufacturing Procedures and Controls Back to top 1. Pharmacy: Balances are calibrated on a daily basis and all utensils are kept clean. One ingredient is brought into the pharmacy at a time. To avoid any errors or mixups, all containers are labeled and placed in designated areas in the warehouse. Before withdrawal of the raw material, the containers are checked by the operator for correctness of label and receiving number. Work is initiated one batch at a time in the pharmacy following standard operating procedures of weighing and checking each raw material. Weighed batches are labeled and placed on pallets for further processing. A logbook is maintained for all batches prepared by Pharmacy. Each material weighted out is subtracted from the raw material inventory card. Once a particular lot of raw material is exhausted the inventory card is forwarded to the Director of Operations for filing. 2. Mixing and Granulation: Equipment used for blending, granulation and milling are checked for cleanliness by the supervisor before use. Batches are processed following written manufacturing instructions. Upon completion, powder blends are stored in fiber or plastic drums lined with polyethylene bags, sealed, labeled, reconciled, and transferred to the staging area for either compression or encapsulation. If a product is to be reworked because of processing problems, the product is quarantined, appropriate adjustments are made to the formula and records are forwarded to the pharmacy. A logbook is maintained for all batches processed by the blending group. 3. Compression/Encapsulation: The production supervisor checks the equipment for cleanliness, identifies the product to be processed and then transfers the powder blend to the designated equipment. Samples of the product are checked against a retain sample to match color and other specifications as per master formula. A sample is also sent to Quality Control for disintegration testing. If the sample meets specification, the product is entered in the machine logbook and production commences. In process records are prepared and the capsule or tablet weight, tablet thickness and tablet hardness are recorded, as appropriate, every half hour. Tablets are collected in polyethylene lined boxes, labeled kept in the room until the batch is completed. Upon completion of tableting, the product is reconciled and transferred to coating or to the packaging quarantine area. Capsules are collected in polyethylene line drums and upon completion the batch is reconciled. Subsequently the capsules are deducted and sent to packaging. If a product does not meet specification, it may be reworked as per set procedures, and batch records are updated to indicate all adjustments made to the formula and product specification. 4. Coating: Tablets are coated soon after completion of the batch and tablets are collected in polyethylene line boxes. Each batch is reconciled and entered in the coating logbook and then forwarded to packaging for either bottling or bulk packaging. Products that are sent outside for coating are entered in a separate log book for outside services, and upon return they are reconciled and submitted to packaging. 5. Packaging: Upon completion of all processing, the product is inspected by Quality Control for appearance, broken tablets, damaged or overfilled capsules and a sample is withdrawn for testing. A product found to contain minor defects is further inspected before being released for packaging. Products released by Quality Control are either bulk packaged in polyethylene lined fiber boxes, and labeled with complete product information, or bottled and labeled as per customer specification. An expiration date, based on appropriate testing by the customer, is also printed on the finished product. Inspection and packaging records are maintained and samples are withdrawn to be retained by Quality Control for at least one year past the expiration date of the product. 6. Sampling and Inspection: All products are manufactured using Good Manufacturing Practices and are continuously being monitored during processing to ensure product quality and integrity. The tablets are checked and tested on half hour intervals for their physical properties and, if necessary, corrective action is taken to maintain those properties. Representative samples of 100 units are collected for both the core and the finished product for Quality Control testing, customer approval and as Reference Samples, a set for each need. 7. Storage of Finished Goods: The product shall be quarantined and stored under controlled temperature conditions until approval and shipping to the customer.
Quality Control Procedures Back to top Specifications, standards,
and testing and the operating procedures are drafted by the respective
department and approved by the Quality Control unit. Laboratory controls
include the establishment of specifications for raw materials, components
and finished products, and testing procedures to assure product identity,
quality, strength and purity. The Quality Control group also maintains
calibration records of all instruments at suitable intervals and in addition
checks conformance of all operations to the set procedures. In process
testing is performed by the Quality Control chemists to determine whether
the product being manufactured conforms to specifications. 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. |
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These statements have not been evaluated by the FDA. These products are not intended to diagnose, treat, cure, or prevent any disease Warning The information provided on this site is for informational purposes only and is not intended as a substitute for advice from your physician or other health care professional or any information contained on or in any product label or packaging. You should not use the information on this site for diagnosis or treatment of any health problem or for prescription of any medication or other treatment. You should consult with a healthcare professional before starting any diet, exercise or supplementation program, before taking any medication, or if you have or suspect you might have a health problem. You should not stop taking any medication without first consulting your physician. |
