Proposed changes, evaluation

There are two words to watch out for or equivalent. What is called equivalent by a designer or contractor may not be equivalent to the laboratory operator. Sometimes this problem arises when a specified item has been superseded by a new and improved model. However new or improved the new model may be, there could be some reason why it would not be right for a particular application. Any substitution must be viewed as suspect. It is always wise, of course, to listen carefully to all suggestions from building professionals and evaluate the reasons they give for a proposed change, but nothing should go imquestioned. 

It is important to ascertain whether the solid phase of the solute changes during equilibration to produce a different polymorph or solvate, by analyzing the solid phase (using either chemical or thermal analysis, or x-ray diffraction). If a solid-solid phase transition occurs during equilibration, the measured equilibrium solubility will be that of the new solid phase of the solute. Methods of circumventing this problem have been proposed and evaluated [26]. 

A document that indicates cleany what is provided in terms of technology, quality, schedule, and cost A basis in enough detail to be used in controlhng the project and its costs to permit proper evaluation of any proposed changes A device to permit subsequent evaluation of the performance compared to the intended performance A document to control the detailed estimate for the final design, construction, and design... 

The terms LCA and cradle-to-grave analysis indicate that it is not the products per se that are analyzed, but in fact product systems in the sense of the production-consnmption-waste treatment systems (Bousead and Hancock, 1989). However, the function of the product as it is used remains the point of reference to which the environmental impacts are attributed. LCAs assist in evaluating proposed changes to product or process designs so that a tradeoff can be identified. 

Any proposed changes should be evaluated for their impact on the whole system. The necessity for requalifying the system because of changes should be determined. Revalidation and evaluation should be performed depending upon the impact that might be caused by the change. 

As part of the international harmonization of test methods, a proposed change to the USP <905> content uniformity test has been made [12]. This test is more restrictive than the current USP test, especially as the batch mean deviates from target. It is also more restrictive for capsules, since both the tablets and capsules are required to meet the same requirements. A number of USP Pharmacopeial Forum articles have been written by the Pharmaceutical Manufacturers Association (PhRMA) statistics expert team discussing the proposal and their characteristics. An approved version of the proposal is eventually expected. In anticipation of this happening, appropriate modifications to the CuDAL approach have been determined to evaluate the newly proposed test. 

The persons responsible for managing the change process evaluate the feasibility and impact of the proposed change in relation to their area of expertise and authority Areas that should be included in the evaluation process are, as applicable QA, regulatory compliance, area management, the system owner/sponsor, the end-user, and technology professionals (e.g., IT, engineering). 

It is important to maintain control of any changes to submission commitments. Any proposed changes should be reviewed and evaluated through a formal change control mechanism that includes a review of the impact of any changes to processes that are currently in place and that have been validated, such as manufacturing controls and methods. 

Change control is a tool that can be used both prospectively and retrospectively. When used retrospectively, it can reveal the complete history of the analytical method and any changes that have been made to it. When used prospectively, it provides the appropriate parties the opportunity to evaluate the impact the proposed changes would have on the method. 

An effective change control system must allow a firm to proactively evaluate proposed changes to a method before they are implemented. 

Failure to complete registration stability studies Failure to include each marketed product in the stability program Stability data not evaluated as part of the annual product review Stability results do not support expiration dating period Batches evaluated under QA requested studies released before sufficient data were available Stability data do not support proposed changes... 

The purpose of change management and control procedures is to document, evaluate, and manage proposed changes in such a way as to maintain the validated system. 

Provides a systematic and formalized approach to review proposed changes. A system helps ensure that change justification is documented and the right people are evaluating and approving each change, and identifies other systems impacted. 

The supervisor must determine if it seems to be a true change or a replacement in kind as previously defined. In an ideal situation, the unit supervisor and the second-level supervisor (SLS) should discuss the proposed change prior to spending a lot of time generating the MOC form and starting the evaluation. It may be that the second-level supervisor has information that such changes have been unsuccessfully tried before, or there is no money in the budget or similar roadblocks. 

Naturally, some of the boilerplate information such as requesters name, a good description of the proposed change, any associated equipment numbers, a target date for completion and other descriptors must be filled in on the form. The reason (or the technical basis) for the change must also be described. In addition, any supplementary documentation that would be helpful for evaluation should be routed with the MOC form. See form 11—1 on the following page. 

Regarding drug formulation and development, the safety and efficacy studies should be evaluated to check if they were performed using the formulation for the proposed dosage form. Bioequivalency should be demonstrated if a different dosage form or formulation was used to conduct the study. Proposed changes should be critically evaluated for their impact on product quality, integrity, purity, safety, efficacy, bioactivity, uniformity, and stability. One should ensure... 

Preliminary laboratory testing may be needed to evaluate proposed changes to established methods. 

An evaluation of the impact of the proposed change on safety and health of employees and the population in the area surrounding the site, and the environment. 

---