Product performance review

This section will describe the typical stepwise process by which Softgels may be developed. The steps generally include fill formulation development, shell compatibility, prototype development (lab scale encapsulation), experimental batch manufacture (process development), clinical supply and conclude with a product performance review of the manufacturing process and specialized formulation approaches to enhance pharmacokinetic performance. 

Product Performance Review/Preparation for Process Validation... 

Communications with customers is the most important approach for understanding their requirements. This can be initiated by the customer as well as by the supplier. The customer-initiated feedback can be through formal product requests, product returns, field application data, and audits. The supplier-initiated feedback may include product-performance reviews, market trends, technology integration, competitive analysis, and design-characterization models. 

Before investigating any one or a group of any materials, product performance and environmental conditions are to be determined. This is a major area of product failure because, in most cases, a complete set of requirements is not properly determined. A few or many requirements may exist. Examples of a few of these requirements are reviewed. 

There are conditions during the fabrication of plastic products that ensure meeting product performance requirements. However there are also constraints as reviewed in Chapter 8. 

In addition to the product, the designer, equipment installer, user, and all others involved in production should all consider performing a risk assessment and target in the direction of perfection. The production is reviewed for hazards created by each part of the line when operating as well as when equipment fails to perform or complete its task. This action includes startups and shutdowns, preventative maintenance, QC/inspection, repair, etc. 

Material and process interaction and their effects on the performance of plastic products are important factors for the designer to understand. It can result in design limitations such as a selected material meeting performance requirements but not pro-cessible by the desired method of fabrication. Most of the limitations that are reviewed in this book can be corrected and do not effect the product performances when qualified people handle the limitations. However they are presented to reduce or eliminate potential problems. 

The many problems that are reviewed in this book should not occur. They can be eliminated so that they do not effect the product performances when qualified people understand that the problems can exist. They are presented to reduce or eliminate costly pitfalls resulting in poor product performances or failures. With the potential problems or failures reviewed there are solutions presented. These failure/solution reviews will enhance the intuitive skills of those people who are already working in plastics. 

Tier I review A focused administrative but nonscientific labeling review of submissions for low-risk products. This type of review would include no evaluation of data to substantiate product performance claims. 

Whether employed in academe or industry, most interviewees reported that research productivity was critical in performance reviews for promotional... 

Compatibility and safety for topical delivery systems are addressed in the same manner as for topical drug products. Performance and quality control should be addressed for the rate-controlling membrane. Appropriate microbial limits should be established and justified for each delivery system. Microbiological standards are under development therefore, the review division for a specific application should be consulted. 

The quality assurance procedures should establish the circumstances under which revalidation is required. These may be based upon equipment, process, and product performance observed during the initial validation challenge studies. It is desirable to designate individuals who have the responsibility to review product, process, equipment, and personnel changes to determine if and when revalidation is warranted. 

In a global production structure with IT-based information flows that substitute one-to-one relationships, forecasting and planning processes need to be brought to a new level. As mentioned above, this requires clear standards for their execution, support from IT systems, and - most importantly - dear and visible accountability for process quality. More spedfically, the forecast accuracy has to be an element of the performance review and incentive system for the product managers and sales force. 

As indicated above, it is imperative for QA and production to review the documentation of the batch record while in process. This review should be made periodically to verify that all steps are completed accurately and in a timely manner. Online QA verifications can also be performed prior to commencement of activities by production. These verifications can include cleanliness checks of rooms and equipment, confirmation of accurate lot number and expiration date during packaging operations, or verification of raw materials used in the process. An evaluation should be made by QA and production management as to which critical steps should be verified by QA. 

A brief overview of product performance during the review period. 

An overall summary of the product performance during a review period. 

However, some excipients have multiple functions. For example, microcrystalline cellulose can function as a filler, a binder, and a disintegrant. As seen in Table 7.3, a typical low-dose formulation could include more than 85% filler—binders. Thus, physical and chemical properties for these specialty excipients are extremely important in a low-dose formulation for manufacturability, product performance, and longterm stability. Because the poor physicomechanical properties of components are not altered during manufacture as they are in the wet or dry granulation process, critical material properties and their impact on product quality attributes should be well characterized and understood.23 Discussion in this section will focus on fillers-binders. For those requiring more information on excipients, several excellent books and review articles are available in the literature.24-27... 

Reduce ECU Catalyst Fines Evaluate possible performance of more attrition-resistant ECU catalyst to reduce fines production. (Subsequent review with catalyst vendors indicated the Refinery was already using the most attrition-resistant catalyst available.) Two other fines reduction options were considered. 

Abstract The source, composition and suitability of crude oils for base oil production are reviewed. The physical and chemical properties of alkanes, naphthenes and aromatics and their characteristics for lubricant applications are examined. Properties and applications of various base oils are defined and specified. Production of conventional mineral oils is described, including the various processes to remove wax and other deleterious substances, followed by increasingly severe hydrogenation to produce base oils of increased quality and performance. The API categorization of mineral base oils, either direct from the refinery or after hydrotreatment of increasing severity, is described, together with sub-categories. 

---