Procedure Verification

The following general rules are recommended for dispensing PET radiopharmaceuticals  

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Establish Verification Procedures. Verification can be performed independently by the manufacturer and the regulatory agency to determine that the HACCP system within the plant is in compliance with the HACCP plan as designed. 

In the NMKL procedure, verification is an important aspect of continuous documentation of the quality of on-going analyses performed with validated methods. 

Software logic functions and automatic process sequence operation Standard operating procedures verification Data records and reports Power loss and recovery... 

The vendor qualification policy will ensure that vendor qualification activities are performed under the auspices of quality assurance. Additionally, a thorough review of the vendor qualification ownership will be performed, and additional resources will be assigned, if needed. An expanded training program will be developed and implemented to ensure that all staff associated with the vendor qualification program are trained on the new and improved policy and procedures. Verification and monitoring of conformance with the company s vendor qualification policy and procedures will be performed periodically through internal company audits. 

OQ should include backup and recovery, data archive and retrieval, security, system administration procedure verification, startup and shutdown, UPS continuity, communications loss and recovery, and systems redundancy challenges such as mirrored drives, secondary systems, and failsafe systems. 

Expenditure for compliance with company policies and for environmental reviews, auditing procedures, verification, and registration can vary according to company size. Consultation fees of 10,000-50,000 can be expected for small companies, with an addition of 10,000-20,000 for intermediate size companies. Results from the UK report costs of 15,000 for internal preparation and an additional 7000 for external verification [22]. 

Establish verification procedures Verification activities determine the effectiveness of the plan and to ensure correct system operation. 

Add to procedures verification step that three operators are present during task activity director, spotter, and crane operator. 

WSRC, Manual RD 7.1, Procedure DMP 7.03, Rev.O, "Symptom-Based Procedure Verification and Validation."... 

The verifications can be performed by the user himself, with electronic measurement equipment described in this project. The consequences of the application of future European standard are very important since is established a mandatory verification of each particular flaw detector, at least once a year. Their verification is to be performed according to a well defined procedure of measurement, including acceptance criteria for each parameter. 

Where conformity assessment involves intervention of third party, that task is normally carried out by the notified body. The pressure equipment directive enables in addition the national authorities to authorise in their territory user inspectorates for the carrying out of conformity assessment procedures which relate to product verification. These inspectorates shall act exclusively on behalf of the group of which they are part. The placing on the market and putting into service of equipment which has undergone such assessment is however limited to the territory of the authorising Member State and to those Member States which have also proceeded to such authorisation. The equipment concerned shall therefore not bear the CE-marking. 

The project review process involves multiple steps that should be definea in management gmdelines (CCPS, 1993, pp. 57-61). The steps include (1) review pohcy, (2) review scheduling, (3) reviewtech-nique, (4) review team representation, (5) review documentation, (6) review follow-up, (7) review follow-up verification, and (8) review procedures change management. These steps define how a review, whether it be a safety review, environmental review, pre-start-up review, or whatever, is conducted and how closure of review aclion items is achieved. 

Establish procedures for testing and verification of catalyst activity and identification including use testing. Include procedure to monitor shelf life of catalyst to maintain activity... 

Chemical reaction due to Develop written procedures to clean and equipment not being verify reactor readiness properly cleaned/ drained. jn piement checklist verification from previous run. Possi- bility of unwanted reac- cleaning solvent tion or insufficient desired reaction. CCPS G-15 CCPS G-22 CCPS G-29... 

Provide independent verification Provide proper training and procedures Provide process write-ups Use log book and checklists... 

Process design results in the design output, following which the process has to be constructed or installed, personnel trained capability studies conducted, and process verification performed. It will therefore be necessary to generate several other procedures dealing with each of these topics. 

Prepare procedures for the conduct of design verification activities. 

The standard requires the supplier to establish and maintain procedures for verification of customer supplied product provided for incorporation into the supplies or for related activities. 

Any operation that relies on skills doesn t need a procedure. However, the operator will not be clairvoyant - you may need to provide procedures for straightforward tasks to convey special safety, handling, packaging, and recording requirements. You need to ensure that you don t make your processes so complex that bottlenecks arise when the slightest variation to plan occurs. The setting up of equipment, other than equipment typical of the industry, should be specified to ensure consistent results (see later in this chapter under Verification of job set-ups). In fact any operation that requires tasks to be... 

The product specification should provide all necessary processing requirements that need to be implemented when carrying out particular processes however, some of the requirements may need to be defined in separate process specifications which are invoked by reference. You may need to develop your own process specifications, but there are many national standards that may suit your needs and they come with the added benefit that they have been proven to work. The quality plan or procedures should not contain any further product requirements but may provide the verification methods to be employed, the precautions to be observed and the recording requirements to be met. You need to identify in your production plans each of these documents at the stage at which they should be applied, otherwise there is the possibility that they may be overlooked. 

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