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 the product labeling operation under strict controls. Inventory records 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 be 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. 005 for May 2000), 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 be 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. Representative retained 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 the Pharmacy. All manufacturing records are filed according to product number and lot number, and maintained by the Director of Operations.

MANUFACTURING PROCEDURES AND CONTROLS

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 mix-ups, 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 log book is maintained for all batches prepared by Pharmacy. Each material weighed out is subtracted from the raw material inventory record. 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 log book 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 retained 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 specifications, the product is entered in the machine log book 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 and 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 lined drums and upon completion the batch is reconciled Subsequently the capsules are deducted and sent to packaging. If a product does not meet specifications, it may be reworked as per set procedures, and batch records are updated to indicate all adjustments made to the formula and product specifications.

4. Coating: Tablets are coated soon after completion of the batch and tablets are collected in polyethylene lined boxes. Each batch is reconciled and entered in the coating log book 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 processing, the product is inspected by QC 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 and a determination for corrective procedures is made and effected before released for packaging. Products released by QC are either bulk packaged in polyethylene lined fiber boxes, and labeled with complete product information or bottled and labeled as per customer specifications. 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 QC for at least one year past the expiration date of the product.

6.  Sampling & 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

Specifications, standards, and testing and operating procedures are drafted by the respective departments 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 QC 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 QC 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) arid finished products (for one year past the product expiration date) are maintained under control conditions.

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