cGMP FUNCTIONALITY

 

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).

  • An item can be setup to require a lot number to be specified for each inventory transaction entered against the item. In addition, each inventory record has an associated QA status (i.e. quarantine, approved, reject, etc.) and retest and expiration date.

  • If the lot number has already been received, it cannot be received again with the same lot number unless the previous PO receipt transaction is rolled back. A rollback can only be performed if the inventory record for the received lot still resides in the receipt location.

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

  • The QA Release Required option on the Product page of the Item Master specifies whether or not a batch must be released by QA prior to use in production. If QA release is required, the default QA status for a batch received into inventory is ‘Quarantine’. If QA release is not required, the default QA status for a batch received into inventory is ‘Conditional Release’. The 'QA Release Required' option is applied to both purchase order and shop order receipt transactions.

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

  • A batch cannot be issued to a production lot unless it has first been approved by QA. When QA enters a disposition for a batch record, it automatically updates the QA Status of the associated inventory record(s).

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

  • The lots available to allocate to a parent shop order are sorted by batch number and include references to both the retest and expiration date to provide visibility of inventory status and facilitate the use of older inventory first. For backflush components, batches are consumed in expiration date sequence at the time of the parent shop order receipt.

• Sec. 211.87 requiring appropriate retesting of components.

  • The Retest/Expiration Date Report lists the inventory records that meet the specified selection criteria. The report can be reviewed on a regular basis to identify batches that will either need to be retested or expire within the upcoming review period.

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

  • Reject material cannot be allocated or issued to a parent shop order. In addition, the increased visibility of the QA Status on the inventory record reinforces procedures to prevent the improper use of quarantine or reject material.

 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.

  • When dispensing or issuing a lot to the parent production batch, the item number, batch number, and
    quantity are specified for the material issue transaction. The Shop Order Transaction Detail and Quantity Variance Reports are used to identify missing or incomplete issue transactions based on the quantity received of the parent shop order.

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

  • The Shop Order Transaction Detail report provides a process yield for each shop order and an historical process yield over a selected date range by item.

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

  • The same control applies as in Section 211.84. The system control is reinforced by a physical QA status label attached to each container.

Subpart G

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

  • The same control applies as in Section 211.84. The system control is reinforced by a physical QA status label attached to each container.

• 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.

  • The Lot Tracking Report - How Made displays the materials required by lot number in the production of a batch. The How Made report can be used to investigate consumer complaints to determine the items and lots that went into the final product. For information
    on how a particular lot was used, the Lot Tracking Report - Where Used identifies the end items a lot was used in the event of a product recall or safety notice.

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.

  • The Receiving Report indicates the identity and quantity of goods received including the supplier name, supplier's lot number,
    assigned lot number, and receipt date.

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

  • The Product Configuration Master can be found in the Data Maintenance menu and is used to build and maintain the route and bill-of-material (BOM) for a manufactured or outside process item. The operations and materials are entered on the Bill of Resources page and displayed graphically
    on the Indented View page. The multi-level bill-of-material structure can also be printed in indented format.

  • The product configuration is used as a basis for creating shop orders for the parent item. A copy of the product configuration is made each time a shop order is created for the parent item. The product configuration also serves as the basis for material requirements planning (MRP) and product cost rollups to update standard material, labor, and overhead costs.

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

  • An Allocation/Dispensing Sheet is printed and included in the shop packet distributed to production. The operator uses the Allocation/Dispensing Sheet to document the actual materials dispensed and consumed in production. This form then serves as the basis for entering material issue transactions into the system.

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

  • The Sales By Customer Report displays shipped batches with the product name and description, customer name, ship/invoice date, ship quantity, and lot number.

Subpart K

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

  • The Return Material Authorization screen is used to process customer returns for goods shipped back from the customer after shipment. The RMA generated during the process can be used to track the status of a return, update inventory, and issue a credit memo if required.