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 or other vermin. Finished products may be stored in a climate-controlled environment. Individual dust collection units service the areas of pharmacy, blending, tableting, encapsulation and coating. For performance of specific operations, separate rooms or cubicles with appropriate equipment and separate air handling systems that use negative air pressure for the prevention of cross-contamination.
Production and Process Controls
Written procedures are strictly followed in production of nutritional products to ensure their identity, strength, quality and purity. In-process controls are 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.
Production team makes sure they properly maintain and clean the equipment used in the manufacturing of products 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.
To ensure batch uniformity and integrity of the product, control procedures in each production run include:
3. Tablet thickness
4. Tablet hardness
6. Disintegration time
7. Dissolution time
In-process specifications are consistent with finished product specifications. If the purity or quality of the product is compromised while still in production, it is rejected.
Raw materials are purchased from reputable suppliers. With each of the raw materials, a Certificate of Analysis is obtained from the supplier. All raw materials received are identified and checked for their physical characteristics, and identified according to the supplier label claims and the purchasing department. The Quality Assurance group generates an inventory card is generated for each lot of material to be used by the pharmacy to maintain the log of material use. Samples are withdrawn and submitted to Quality Control for testing according to specifications SOP’s.
Containers, closures, cotton, seals and polyethylene bags are obtained from reputable suppliers and physically checked upon arrival for quality and specifications. Customer’s labels are checked against the master label, kept in locked cabinets, and are issued in product labeling operation under strict controls.
A master formula and product number is issued for each product. The formula contains the name, strength, specifications, ingredients and quantities to be used. It also includes the 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.
Lot Number and Batch Size:
Upon receipt of an order, the product to be produced is entered in the master production book and a lot number is assigned according to SOP process. A complete lot number for example would appear like: 055-0120. Production personnel determine the size of each batch. Each lot, or sub lot is produced and tested.
Issuing of Batches:
When an order is received, 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 in-process control records to be used during manufacturing. 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 Directory of Operations.
Manufacturing Procedures and Controls
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 Production Manager for correctness of label and receiving number. Production is initiated one batch at a time following SOP’s 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.
Mixing and Granulation:
Equipment used for blending, granulation and milling are checked for cleanliness by the supervisor before each 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 needs to be reworked because of processing problems, the product is quarantined, appropriate adjustments are made to the formula, and the records are forwarded to the pharmacy. A logbook may be maintained for all batches processed by the blending group.
The Production Supervisor checks the equipment for cleanliness, identifies the product to be processed, and 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. Tablets and capsules are collected in polyethylene-lined drums and boxes and labeled. They are kept in the production room until completed.
Tablets are coated soon after completion of the batch and each batch is is reconciled and entered in the coating logbook and then forwarded to either bottling or bulk packaging.
Upon completion of the production process, 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 or labeled with complete product information. An expiration date is noted.
Storage of Finished Goods:
The product shall is quarantined and may be stored under controlled temperature conditions until approval and shipping to the customer.
Quality Control Procedures
During the production process, specifications, standards, 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, finished products and testing to assure product identity, quality, strength and purity.
Reports and Records:
All production and analytical records associated with a batch of a product may be retained in the facilities where your dietary supplement was produced.