Production procedures are established in order to assist in providing a systematic and sequential method in the manufacture of a pharmaceutical product. The procedure has built-in safeguards for the manufacture, control, packaging, labeling, testing, record keeping and release in order to provide a safe and correct product for use in patient care.

1. Before any product is prepared a control number is assigned, a manufacturing form is prepared and an entry is made on the Log of Production and Control.

2. All chemicals or any other component of the product or the prepared product itself must be properly identified during all steps of the manufacturing process. Any labels used must contain the chemical name, quantity, manufacturer’s name, control number, and the initials of the person verifying the label.

3. All weights and measures will be checked by a pharmacist or other qualified professional person.

4. On completion of manufacture and just prior to labeling the product, the following steps should occur.

1. The product is packaged

2. The yield is recorded on the Log of Production and Control

3. Samples are submitted to the Control Lab. The samples are to be labeled with the product’s final label.

5. The product is labeled.

6.  If the product is a sterile preparation or a non-sterile one intended for patient use the entire yield of the product is kept in the quarantine area Large volume products such as soaps and disinfectants are stored on steel shelving in their regular storage area with a red "Do Not Use" card marking each shelf on which the quarantined product is placed.

7. The manufacturing and control sheets are sent to the Control laboratory.

8. The Control Laboratory will pass or reject the product according to tests performed.

1. The forms are checked that the yield data has been entered on the Manufacturing Form and on the Log of Production and Control.
2. The Manufacturing Form is checked for proper countersignatures and completion.
3. The product is subjected to quality control procedures as discussed in the Quality Assurance section of the Manual.
4. The results of assays and sterility testing are then recorded in the proper records.
5. If the product passes the control procedures, the notice of release from quarantine is recorded and the product may received a green "Safe for Use" card.
6. If the product does not pass the control procedures, the Quality Assurance pharmacist is notified and the product must be discarded.

9. Quarantined products will be handled as follows.

1. For manufactured products which pass the control procedures the green "Safe for Use" card replaces the red " Do Not Use" quarantine card and the product may be used. At the time that the product is released from quarantine a final check is made to assure that the Manufacturing Form is checked against the Log of Production and Control. The Control technician then indicates on the Log of Production and Control that the product has been released and dates it.
2. For manufactured products that do not pass the initial control procedure, the data will be discussed with the Quality Assurance pharmacist. All data will be checked to determine if there is a discernible error. The product will remain in quarantine. If the product can not be salvaged, a decision to destroy the product is made by the Quality Assurance pharmacist.

10. When the final disposition of the product is determined the Manufacturing Form is filed.