Qualification and acceptance

Test specifications to be produced which define the features and characteristics that are to be verified for design qualification and acceptance... 

Only physicians who have enrolled in GlaxoSmithKline s Prescribing Program for Lotronex, based on their attestation of qualifications and acceptance of responsibilities, should prescribe alosetron (see Administration and Dosage). Alosetron is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have failed to respond to conventional... 

Product Acceptance. Propellant furnished accdg to this document shall be inspected for quality in accordance with qualification and acceptance inspection requirements, outlined under Quality Assurance Provisions, items 4.1, 4.1.1, 4.1.2 and 4,1.3 (not included in our description)... 

Computer Systems Validation (CSV) The formal assessment and reporting of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance, and retirement, such that the user has a high level of confidence in the integrity of both the processes executed within the controlling computer system(s), and in those processes controlled by and/or linked to the computer system(s), within the prescribed operating environments) (MCA). 

Another unique element of the ISS verification program is the frequent use of protoflighf versus conventional qualification and acceptance testing. The conventional hardware verification approach includes qualification testing (in... 

For at least one industry, the experience modification system is particularly significant. For construction, it is common practice for a bidder s experience modification to be one of the qualification and acceptance criteria used by the contracting entity or a general contractor. 

An effective procurement process to ensure that the proper parts, materials, and services are available when needed must be in place for restart. Policies should be established for the procurement of parts, materials, and services that are used in maintenance activities on important-to-safety and safety-related systems. Quality assurance procurement records need to be controlled and maintained to provide documentation for qualified parts and materials and ensure traceability of parts and materials. Deficient or nonconforming items should be resolved in an effective and timely manner. A process should be provided to qualify non-qualified material, A process of acceptable substitution should be provided to obtain parts that are no longer available. Design requirements should be reviewed by appropriate personnel to ensure the upgraded or substitute parts are consistent with the application of the part and component. Retrievable documentation should exist to support the identification of inspection and testing requirements necessary to ensure the qualification and acceptability of the part. Personnel must understand their responsibilities in regard to the implementation of the requirements of the procurement program and policies. 

Quality systems require that facilities and equipment should be appropriate to the activities undertaken. Surfaces that are easy to clean and maintain in hygienic condition are a requirement in many situations. For example, cloth-backed chairs would not be acceptable in a laboratory that handled potentially biohazardous materials. Equipment should be checked at installation to demonstrate that it can perform its desired function. This is frequently done using an Installation Qualification, Operational Qualification and Performance Qualification (IQ /OQ/PQ) commissioning process. Routine maintenance and calibration programmes are then required to ensure that equipment continues to deliver the specified performance. 

Impurities in drug substances and drug products continue to be a source of great concern, discussion, debate, and research. " These concerns and debates typically center on the potential safety risks associated with impurities due to contamination and the setting of acceptance criteria. However, the bulk of the work being performed in the pharmaceutical industry, with respect to impurities, is focused on the isolation, identification, qualification and quantification of impurities that are found as a result of the manufacturing process or through chemical decomposition. On the... 

Instrument qualification or validation refers to the process of demonstrating an instrument s suitability for its intended use. The first step is to write protocols to cover the four main qualification elements design qualification, installation qualification, operational qualification, and performance qualification. Another qualification element, re-qualification, can be written as a separate protocol or included as part of the PQ protocol. These protocols must be performed in sequence. If the protocol meets its acceptance criteria, then the next protocol in the sequence can be executed. 

Potlife. Batch qualification and casting usually take several hours during which time the propellant must stay fluid. This time is called potlife and obviously depends on such factors as catalyst level and temperature of the propellant batch. Reduction of the catalyst concentration to obtain an acceptable potlife is not always advisable because it may prolong unduly the time for complete cure. Further, unreacted hydroxyl and/or isocyanate groups tend to undergo undesirable side reactions. 

Qualification of Process Equipment Test Functions and Acceptance Criteria... 

The sterilizer utilization list and the following OQ test requirements summary will be utilized to determine the products assigned to the sterilizer that shall be subjected to the type and number of test function runs required to establish overall sterilizer qualification or validation. The test function subsections shall include test objectives, test methods and acceptance criteria, as follows. 

For simple analytical instruments, a simple table to summarize the qualification testing, acceptance criteria, results, and pass/fail decision of the tests will be sufficient since there are fewer tests that are required and the tests are usually relatively simple. For complex analytical systems, a more complex table often referred to as a traceability matrix which traces the requirements, testing, acceptance criteria, test results, and storage locations of the validation documents, test data, and other supporting documents is usually included in the summary report for easy reviewing and quick references. 

Validation protocols are required to describe the objective, methodology, and acceptance criteria for installation, operational, and performance qualifications. They are written to ensure test methods, and acceptance criteria are reviewed and approved before qualification of protocols. In practical terms, there are several stages for the production of protocols. First, an acceptable format needs to be agreed. No universal format exists for protocols, but to some extent, the type of equipment, the size of the project, and the personal preferences will dictate the protocol style. However, some norms have been established. Like other controlled documents, protocols are assigned unique reference numbers and revision numbers. They are titled and numbered on every page and have a particular place for approval signatures. Other common elements in protocols tend to be brief descriptions of the item being qualified and a clear statement of responsibilities. 

A validation report is a written document that cross-references the validation protocol, summarizes the results obtained, describes any deviations observed, and draws the necessary conclusions, including recommending changes required to correct deficiencies for the qualification and validation performed [5]. In this report it is required to present both the results and conclusions and the secure approval of the study. The report should include a summary of the procedures used to clean, sample, and test as well as the physical and analytical test results or references for the same. The conclusions regarding the acceptability of the results should also be included. Other information would be the status of the procedures being validated, any recommendations based on the results, or any relevant information obtained during the study. These include, re validation practices (if applicable), the approved conclusions, and any deviations of the protocol that might have occurred. In cases where it is unlikely that further batches of the product will be manufactured for a period... 

Instrument qualification is required to establish the functional capability and reliability of a system for its intended use in a suitable environment. Instrument qualification can be divided into three stages installation, operation, and performance qualifications. A qualification protocol that provides details about the system, the scope and constraints of the qualification, qualification tests, test procedures, and acceptance criteria should be available for review and approval before qualification begins. Sufficient time should be provided for review and approval. The protocol should also contain an exception log to record any out-of-specification results, investigation, and problem resolution. 

Performing an operational qualification procedure ensures that the specific parts of an instrument are functioning according to defined specifications for precision, linearity, and accuracy. For operational qualification, testing individual instrument parameters and comparing them to accepted values requires isolating each parameter. Each parameter is related to a specific CE function. Typical CE functions that are subjected to qualification and their associated parameters are shown in Figure 12.2. 

It is essential that an environmental chamber be qualified at its intended range of use prior to commissioning for routine operation in a stability program. A qualification protocol should be prepared describing the qualification procedures and must include predefined acceptance criteria for successful qualification. The qualification consists of three components an installation qualification, operation qualification, and performance qualification. 

Suitability refers to the tests and studies used and accepted for the initial qualification of a component, or a container closure system, for its intended use. Quality control refers to the tests typically used and accepted to establish that, after the application is approved, the components and the container closure system continue to possess the characteristics established in the suitability stud-... 

To establish safety and to ensure consistency, the complete chemical composition should be provided for every material used in the manufacture of a packaging component. Test results from appropriate qualification and characterization tests should be provided. Adequate information regarding the tests, methods, acceptance criteria, reference standards, and validation information should be also provided. 

Retrospective validation involves using the accumulated in-process production and final product testing and control (numerical) data to establish that the product and its manufacturing process are in a state of control. Valid in-process results should be consistent with the drug products final specifications and should be derived from previous acceptable process average and process variability estimates, where possible, and determined by the application of suitable statistical procedures, that is, quality control charting, where appropriate. The retrospective validation option is selected when manufacturing processes for established products are considered to be stable and when, on the basis of economic considerations and resource limitations, prospective qualification and validation experimentation cannot be justified. 

One final comment. When you read a paper or listen to a lecture offered by a researcher of impeccable qualifications, take a moment to look about you to see who is along side you in the audience that is being addressed. Who else is reading his paper Who else is hearing his lecture How might the presentation be tailored to fit the interests of the recipients The identification and recognition of your neighbors should play a role in your evaluation and acceptance of the presentation. 

---