Supplement Manufacturers & Quality control:

Are you looking for supplement manufacturers that private label supplements in The United States Of America in a FDA registered facility following GMP production guidelines?  – At Nutra Group only the highest quality ingredients are used in the manufacturing process. When you partner with us, you can rest assure that your Private Label formula meets or exceeds industry standards.

 

Quality control measures that may be followed in the facilities where your private label product or custom formula is sourced and produced:

 

Organization and Personnel

Production of formulas is structured to provide all of the necessary measures and controls for the manufacture of products of the highest quality. We meet safety requirements and possess the identity and strength needed to create the best product possible. An adequate number of qualified personnel are assigned to perform and supervise the production of the nutritional products, and personnel 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 production of your dietary supplement.

A quality control unit may consist 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.

In the production process, the quality control laboratory is fully equipped for testing raw materials and finished products to regulation specifications. Samples of raw materials and finished product may be retained  for a pre-established period.

Building and Facilities

The manufacturing area facilitates the operation from receiving raw materials to the 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 completed products.

Areas allocated to different operations:

a. Receiving and quarantine area
b. Warehouse for storage of raw materials and other components
c. Staging area for storage of in-process materials
d. Pharmacy and blending.
e. Production area for encapsulation
f. Production area for tablets
g. Coating area
h. Packaging and labeling area
I. Area for storage of finished products

Private label vitamins sourced from a USA - GMP certified facility or a FDA registered facility

Adequate lighting and ventilation is provided throughout the supplement manufacturers 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:
1. Appearance
2. Variation
3. Tablet thickness
4. Tablet hardness
5. Friability
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:

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.

Stock 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. Customer’s labels are checked against the master label, kept in locked cabinets, and are issued in product labeling operation under strict controls.

Master Formula:

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 supplement manufacturers 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
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 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.

Compression/Encapsulation:

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.

Coating:

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.

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 supplement manufacturers facilities where your dietary supplement was produced.