The Initial Qualification Process

Candidate tollers should be made aware of special insurance needs the proposed toll will require as soon as possible in the initial qualification process. Clients should ask to see a toller s standard insurance certificate to verify coverage. It is common to check for ... 

Iowa Public Service Company continued to purchase DuPont plastic piping fittings until fittings were available from Century. MidAmerican Energy made technical procurement decisions via a Gas Standards Committee. According to company officials, the company has implemented a process to ensure that it continues to receive quality products once the products have passed an initial qualification process. 

The term approval can be taken to mean certification or qualification, the difference being that certification is performed each time the equipment is repaired and qualification only when the equipment is introduced into service. The standard only refers to the term qualification in connection with special processes, but this clause does not distinguish between special and ordinary processes and equipment. However, there are two levels of approval that apply to processes and equipment initial qualification approval and periodic setting-up approval. 

A. When developing a dissolution method, the design qualification is built into the apparatus selection process. The dosage form and delivery system process will dictate at least initially the equipment of choice. For example, the first choice for a beaded product may be United States Pharmacopeia (USP) Apparatus 3, which is designed to confine the beads in a screened-in cylinder. 

The certification activities include a series of process documentation and qualification studies that start with the initial installation of a sterilization system and continue as process engineering changes or new or revised product introductions are required. Qualification activities comprise installation, operational, change, and performance phases. 

Qualification of equipment and validation of computer systems are not one-time events. They start with the definition of the product or project and setting user requirement specifications and cover the vendor selection process, installation, initial operation, ongoing use, and change control. 

In this chapter we guide quality assurance (QA) managers, lab managers, IT personnel, and users of equipment hardware and software through the entire qualification and validation process, from writing specifications and vendor qualification to installation and initial and ongoing operation. The following points are covered ... 

Of course these pieces or steps begin in development with initial process-development activities and conclude with product commercialization. All pre-process validation activities—from the initial ranging studies to the process-specific validations—can be dubbed as PQ activities, since they create a certain level of comfort with the process. These activities typically involve more than three full-scale runs—the number usually associated with validation. How exactly does this work How can a qualification require more runs than a validation The answer is very simple validation includes qualification, which means... 

Equipment qualification—Definition of the equipment, system, and/or environment used for the process. These data are used to gather a baseline of the installation/operational condition of the system at the time when the performance qualification (PQ) of the system is performed. This baseline information is used to evaluate changes to the system performance over time. Intentional changes from these initial conditions must be considered and evaluated to establish that the system s performance is unaffected by the change. Unintentional changes in the form of a component or equipment malfunction or failure can be easily rectified using the available baseline data as a basis for proper performance. 

The firm failed to document how each specific supplier is evaluated in order to assure their products meet specified requirements as required by their Vendor/Supplier Qualification SOP. Additionally, the firm failed to complete adequate purchasing controls in that they fail to ensure that the initial audit of suppliers is conducted prior to the supplier s acceptance, firm fails to assure components meet specifications (physical specifications), and fails to document in-process rejects. 

Safety concerns may arise from the presence of impurities or contaminants. It is preferable to rely on purification processes to remove impurities and contaminants rather than to establish a preclinical testing program for their qualification. In all cases, the product should be sufficiently characterized to allow an appropriate design of preclinical safety studies. In general, the product that is used in the definitive pharmacology and toxicology studies should be comparable to the product proposed for the initial clinical studies. (ICH S6)... 

At the end of the PQ a report will be produced which summarizes the continued operation of the LIMS for the initial period following going five. During the period of the PQ, LIMS is expected to have stabilized in terms of user support requests, system performance, and changes implemented as a result of the qualification process. 

The sensitivity tests in the model qualification studies confirmed some of the suspicions that we expressed earlier (87)—Le, that the quasi-equilibrium relationship between ozone and the oxides of nitrogen does not seem to be recovered in the data. The largest departures are for the highest ozone levels. Attempting to represent the physical setting consistently, we find it difficult to use the measured ultraviolet intensity to account simultaneously for the observed ozone buildup and NO-conversion simultaneously. The inconsistency even appears in the initial behavior of a modeling run as a transient induction process that rapidly... 

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