Shipment validation

The automated conveyor sortation and shipping system design were based on supply chain requirements for surge and seasonal volumes for both package carrier and LTL shipments, validation of complete shipments (scan verihcation of each carton and validation of check weights), confirmation of pallet contents for multiple pallet orders, and sufficient throughput capacity. 

The source process outlines the ordering and obtaining of goods and services. This includes for example the scheduling of deliveries, shipment validation, and acceptance of supplier invoices (SCOR 10.0). 

Persson JA, Gothe-Lundgren M (2005) Shipment planning at oil refineries using column generation and valid inequalities. European Journal of Operational Research 163 631-652... 

The receiving, unpacking, and aliquoting of various actinide materials is the primary function of sample management (SM) in the actinide analytical chemistry group at Los Alamos National Laboratory. Upon receipt of a sample shipment, the contents of each container must be closely validated with the labeling on the container and with the paperwork that accompanies the shipment. Any discrepancy must be immediately rectified. 

The differing circumstances under which a validation study is prompted often dictate the best approach to be used. Agreeably, prospective validation, for which the validation studies are all completed and approved before shipment of any product, is preferred. There are however, opportunities to complete certain validation studies when producing product intended to be administered to patients. Such circumstances may arise during clinical manufacturing, when exten-... 

Documentation of the installation can also be included within the IQ section of the validation package. Part of this documentation may take the form of an installation checklist. This checklist would include each specific activity necessary for the installation of the lyophilizer, who completed and checked the work, and the date the work was completed. These activities would include assembly of the various lyophilizer parts (if dismantled at the factory for shipment) and the connection to utility supplies. In some circumstances, these activities and the associated documentation may have been completed during the commissioning of the equipment. 

In 1990, when FDA launched its preapproval inspections (PAI) program, the three-lot issue again arose. The PAI s chief architects (Richard Davis and Joseph Phillips, FDA Newark district directors) announced they would require evidence of three consecutive successful lots of commercial size prior to shipment of a new product across state lines as final evidence of process validation, even when the firm had already received its NDA approvable letter. 

Can the vendor guarantee access to software development documents This question is particularly important for those working in the regulated environments. Shipment of a declaration of system validation with each software or computer system provides such evidence. This declares that each software product and their actual revisions have been validated and that additional information on product development can be made available. 

Whereas readers are referred to these specific documents for details available on the Web site http //www.fda.gov/cder/fdama, some of the specifics are briefly mentioned here. The essence of this guidance emphasizes the importance of the overall quality assurance in manufacturing a PET radiopharmaceutical. All equipment and measurements used in the manufacture must be validated. The areas and hoods in which PET radiopharmaceuticals are manufactured must be run in a sterile condition. The personnel responsible for the manufacture must be well trained in the methodology, and an appropriate number of personnel are required in a production laboratory. Each step of the production must be verified and records must be maintained. The sterility and pyrogen testing of the finished product must be performed by appropriate methods. If a PET radiopharmaceutical is to be commercially distributed, appropriate containers and techniques must be adopted for safe shipments. 

Each container or grouping of containers should be identified with standard nomenclature and a distinctive code for each lot in each shipment received, which should be used in recording the disposition of each lot Each lot should be appropriately labelled and identified as to its status (i.e., quarantined, approved or rejected). This may be done manually or the status may be controlled by appropriate and validated computer systems. 

Document the reasons for not completing process validation before shipment of the API ... 

In the development of the process automation and control system, the required testing of that control system and the factory-assembled components, and the process simulation program must be established with the general functional specifications. In an API facility, many of the control systems perform process functions that require strict validation. The functional description for the automation system should require a complete factory acceptance test (FAT). This test should simulate the entire process and process failures and alarms. The FAT should also check and verify that the control system cabinets and controllers operate as designed. The factory acceptance testing of the process automation system prior to shipment and installation in the field is a critical step in the validation and start-up of the facility. 

The focus of the product-maintenance stage is to ensure continued product success in the market. The manufacturing and operations teams ensure that product meets all requirements and continues to be robust. This activity ensures stable shipment of product to customers. In addition, periodic quality assurance audits are conducted to determine continued compliance relative to quality system requirements. This is the stage where all required design and platform activities are validated using large samples and appropriate corrective actions and continuous improvement activities are implemented. 

Negative certification that a shipment is not subject to TSCA These must be filed at the port of entry Blanket certifications are valid for one year... 

The validation calculations with MERIT indicated that KENO, used with Hansen and Roach cross sections, overpredicts the reactivity for the water-flooded fuel ease by <2% and underpredicts the dry fuel case by <1%. This is consistent with previous KENO validation calculations performed by General Electric in support of a fuel bundle shipment container license application. ... 

Corresponding IAEA competent authority validation (acceptance) must be obtained from each transit and destination country. These IAEA competent authority validations need to be included in the shipping paperwork (reference 49 CFR 173.471, 173.472, and 173.473). While a formal competent authority approval is not required for IPs, the shipper may be required to have approval for the package in the coxmtry of origin and destination. This needs to be verified prior to making any international shipment. 

Safety, Operational, and Lean Review At the vendor s location, before shipment of the equipment can be made, the purchaser s environmental, health, and safety personnel assure that all safety-related speciflcations have been met. Factory acceptance testing takes place and members of the review team (engineering, operations, maintenance, validation, etc.) determine that the equipment operates as expected and that waste occurs at a minimum. This is a large part of the approval process prior to shipment of the equipment. The staff has found that testing at this level at the vendor s location has avoided many issues which would have to be resolved later on its shop floor. Review by maintenance is especially important here as their sign-off impacts on the company s ability to apply the Total Preventive Maintenance initiative. With approval, the equipment may be shipped to the purchaser. 

Multilateral approval may be by vaUdation of the original certificate issued by the competent authority of the country of origin of the design or shipment. Such validation may take the form of an endorsement on the original certificate or the issuance of a separate endorsement, annex, supplement, etc., by the competent authority of the country through or into which the shipment is made. 

Many sponsors request that field spike samples be taken. Field spikes of each sample matrix should bracket the expected range of analytical results generated from the assay of the samples. Spikes just above the screening level are necessary to validate recoveries and insure an acceptable analytical method. The number of field spikes should be completely planned and described in the protocol. These samples can be used for quality control and as samples for storage stability during shipment and laboratory storage. 

Verification and validation of all l C systems and components shall be carried out at component and system level, via applicable testing procedures, at the system manufacturer location before shipment. 

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