The Catalyst Manufacturing Pharmaceutical Edition is designed for pharmaceutical companies subject to cGMP guidelines as described in section 21 CFR Part 211, namely:

Subpart E

• Sec. 211.80 requiring a distinctive lot number for each shipment received and each lot shall be appropriately identified as to its status (i.e. quarantined, approved, or rejected).

• Sec. 211.82 requiring receipt and storage of untested components in a quarantine status until tested and released.

• Sec. 211.84 requiring the withholding of component lots from use until sampled, tested, and released by quality.

• Sec. 211.86 requiring approved components be rotated so oldest approved stock is used first (FIFO).

• Sec. 211.87 requiring appropriate retesting of components.

• Sec. 211.89 requiring rejected components to be identified and controlled under a quarantine system to prevent improper use.

Subpart F

• Sec. 211.101 requiring charge-in of components when used in production to identify component name or item code, receiving or control number, weight, and batch for which component was dispensed.

• Sec. 211.103 requiring actual yields and percentages of theoretical yield to be calculated at the completion of each manufactured batch.

• Sec. 211.110 providing for the testing and control of in-process materials under a quarantine system to prevent improper use.

Subpart G

• Sec. 211.122 to prevent use of labeling or packaging material that has not been approved and released by quality control.

• Sec. 211.150 to ensure that oldest approved stock is distributed first and that the system supports identification by lot in the event of product recall.

Subpart J

• Sec. 211.184 requiring shipment receipt records indicating the identity and quantity of goods received including the supplier name, supplier's lot number, assigned lot number, receipt date, and manufacturer name, if applicable. Also, requires inventory records for each component indicating usage and disposition records for rejected components.

• Sec. 211.186 requires master production and control records indicating the product name, description, and a list of required components by weight or measure.

• Sec. 211.188 requiring documentation of components used in the production of each batch.

• Sec. 211.196 requiring distribution records of shipped batches including the product name and description, customer name, ship date, ship quantity, and lot number.

Subpart K

• Sec. 211.204 requiring accurate records for returned goods including the lot number and quantity received.

Pharmaceutical Edition Fact Sheet