Production operations
Raw materials for intermediate and API manufacturing should be weighed or measured under appropriate conditions that do not affect their suitability for use.
If a material is subdivided for later use in production operations, the container receiving the material should be suitable and should be so identified.
Critical weighing, measuring, or subdividing operations should be witnessed or subjected to an equivalent control.
Actual yields should be compared with expected yields at designated steps in the production process. Expected yields with appropriate ranges should be established based on previous laboratory, pilot scale, or manufacturing data- Deviations in yield associated with critical process steps should be investigated to determine their impact or potential impact on the resulting quality of affected batches.
Any deviation should be documented and explained. Any critical deviation should be investigated.
The processing status of major units of equipment should be indicated either on the individual units of equipment or by appropriate documentation, computer control systems, or alternative means.
Materials to be reprocessed or reworked should be appropriately controlled to prevent unauthorized use.
Residual materials can be carried over into successive batches of the same intermediate or API if there is adequate control.
Production operations should be conducted in a manner that will prevent contamination of intermediates or APIs by other materials.
Residual materials can be carried over into successive batches of the same intermediate or API if there is adequate control.
Production operations should be conducted in a manner that will prevent contamination of intermediates or APIs by other materials.
In-process Sampling and Controls
Critical in-process controls (and critical process monitoring), including the control points and methods, should be stated in writing and approved by quality unit(s).
In-process controls can be performed by qualified production department personnel and the process adjusted without prior quality units(s) approval if the adjustments are made within pre-established limits approved by the quality unit(s).
Written procedures should describe the sampling methods for in-process materials, intermediates, and API's.
In-process sampling should be conducted using procedures designed to prevent contamination of the sampled material an other intermediates or APIs.
9.Packaging and Identification Labelling of APIs and Intermediates.
There should be written procedures describing the receipt, identification, quarantine, sampling, examination and/or testing and release, and handling of packaging and labelling materials.
Packaging and labelling materials should conform to established specifications. Those that do not comply with such specifications should be reject to prevent their use in operations for which they are unsuitable.
Records should be maintained for each shipment of labels and packaging materials showing receipt, examination, or testing, and whether accepted or rejected.
10. Storage and Distribution
Facilities should be available for the storage of all materials under appropriate conditions. (e.g. controlled temperature and humidity when necessary). Records should be maintained of these conditions if they are critical for the maintenance of material characteristics.
Unless there is an alternative system to prevent the unintentional or unauthorised use of quarantined, rejected, returned, or recalled materials, separate storage areas should be assigned for their temporary storage until the decision as to their use has been taken.
APIs and intermediates should only be released for distribution to third parties after they have been released by quality unit(s).
Perfect-order execution, written correct schedule and procedures to get avoid contamination, wastes and to get Good Manufacturing Practice.
Total lead time is the sum of all processing time, transit time, and time spent as inventory.
Inbound (supplier) lead time: The amount of time from the point of ordering materials (APIs, raw materials, packaging,..) from a supplier to the point the material is received and available for use.
Manufacturing lead time: The amount of time it takes to send an order to production planning and for the goods to be manufactured and made available for shipping.
Outbound (customer) lead time: The amount of time it takes for a clients order to be received, processed, and shipped to the customer.
Raw material inventory: The amount of inventory that sits as raw material in front of the manufacturing process, measured in average days on hand.
Finished-goods inventory: The amount of inventory that sits in finished goods.