MANUFACTURING PROCEDURES

& CONTROL

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 labelled and placed in designated areas in the warehouse. Before withdrawal of the raw material, the containers are checked by the Production Manager for the correctness of label and receiving a number. Production is initiated one batch at a time following SOP’s of weighing and checking each raw material. Weighed batches are labelled 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 fibre or plastic drums lined with polyethylene bags, sealed, labelled, 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 a colour and other specifications as per master formula. Tablets and capsules are collected in polyethylene-lined drums and boxes and labelled. They are kept in the production room until completed.

 

 

Coating:

Tablets are coated soon after completion of the batch and each batch is reconciled and entered in the coating logbook and then forwarded to either bottling or bulk packaging.

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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product is inspected by Quality Control for appearance, broken tablets, damaged or overfilled capsules and a sample is withdrawn for testing.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 labelled 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.