Product defects

These possible sources of problems in a molded part should be marked on the product drawing and explained to the mold designer for corrective action or creating an awareness of possible product defects. This is a necessary step in the chain of events in which the aim is to produce a tool that will provide useful products. Even if the mold s design, workmanship, and operation are carried out to the highest degree of quality, they cannot overcome a built-in weakness due to the product design. 

This system assures overall compliance with cGMPs and internal procedures and specifications. The system includes the quality control unit and all of its review and approval duties (e.g. change control, reprocessing, batch release, annual record review, validation protocols, and reports, etc.). It includes all product defect evaluations and evaluation of returned and salvaged drug products. 

Scope of Inspection Short description of the inspection (Product related, process related inspection and/or General GMP inspection, reference to specific dosage forms where appropriate). The reason for the inspection should be specified (e.g. new marketing application, routine, investigation of product defect. 

Form FDA 1932 Mandatory reporting of Veterinary Adverse Drug Reactions, Lack of Effectiveness, or Product Defects by manufacturers... 

On further investigation by an internal FDA task force, the following recall definitions were established in 1973, which seemed to better define the types of product defects that currently are being found. The recalls are now divided into the following three classes. 

What product defects would an injection molding operator observe if the following parameters were set incorrectly ... 

One major problem associated with aluminium and light alloy castings is the inability to completely eliminate the various production defects in their structure, such as gas cavities, porosity and intermetallic inclusions. The All-Russia Institute... 

Scandals concerning hazardous substances or product defects that have been made public in a broader context have learning effects, which go far beyond the company concerned. This means that journalistic interest in the subject of chemicals and comparative testing facilities are important drivers for innovation. 

In human case reports, chlordane exposure has been linked to neuroblastoma, aplastic anemia, and acute leukemia, but only circumstantially. In a 1987 report, 25 new cases of blood dyscrasia, including leukemias, production defects, and thrombocytopenic purpura (generally after home termite treatment with chlordane/heptachlor), were reported. The authors noted the rarity of many of the conditions and, hence, the difficulty of finding statistically significant results. 

While most of the previously mentioned causes of haze can create product defects, they do not normally occur if a process is carried out properly. The most frequent cause of haze in clear beverages is protein-polyphenol interaction (Bamforth, 1999 Siebert, 1999). This occurs normally and even when a beverage is properly stabilized, protein-polyphenol haze usually develops eventually. The objective is to delay its onset so that any haze produced is imperceptible until after a product s intended shelf life. 

Works in this section deal with issues of civil liability for the manufacture, distribution, or use of firearms. These include specific cases and general issues such as product defects or negligent marketing, as well as general works about the firearms industry. 

Microspectroscopy applies the identification power of infrared spectroscopy to the microscopic realm. Contaminants on printed circuit boards, blemishes in coatings, and other production defects can be isolated in situ and analyzed (see Electronics, coatings). Analysis of flaws that develop during use illuminates the method of failure. Microscopic samples, such as particulates filtered from air, can be analyzed individually. The forensic applications are many paint chips, single fibers, explosive residues, and inks on currency can all be identified nondestmctively (see Forensic chemistry). The structures of layered materials, such as laminated polymer films, are studied via microspectroscopy by cross-sectioning the materials and examining the individual layers edge on (47). 

Introduction. Defects in citrus juices are manufacturing errors that affect the appearance or palatability of the product. Defects usually take the form of inclusions of harmless material that, in a small degree, may be unavoidable. The definition of a defect does not include any type of foreign material, the inclusion of which is totally unacceptable. 

Effective use of surveillance systems Sampling and analysis Recall monitoring Product defect reporting system Routine surveillance inspections... 

Studies on the functional significance of MFGM-associated enzymes have been restricted largely to their involvement in degradative events that affect processing properties or flavor, or for their use as markers of adequate pasteurization. Obviously, enzymes that can produce product defects are of great concern to the dairy industry. Unfortunately, the biological roles... 

The EU passed a directive in 1993 requiring all food companies in the EU to implement an effective HACCP system by December 1995. The directive covers not only large and medium-sized businesses but also small companies and even small bakery shops and catering establishments. This directive makes the food manufacturer liable for damages suffered as a result of product defects. 

The success of the inspection technique led to the development of the Systems Based Approach for full and abbreviated inspections of pharmaceutical and healthcare companies. Full Inspections are conducted for the initial inspection of a facility, or where a facility has a history of poor compliance, or where signihcant changes have taken place, or for any other cause deemed appropriate. Abbreviated Inspections are applicable when a pharmaceutical or healthcare company has a record of GMP compliance, with no signihcant recall or product defect or alert incidents, or with little change in scope or processes comprising the manufacturing operations of the hrm within the last two years. Both full and abbreviated inspection will satisfy biennial inspechon requirements. 

In addition, you may want to identify areas where you anticipate possible problems, such as bottlenecks, service errors, poor productivity, defects, shift imbalances, changeover snags, and excessive handoffs. Doing this gives you a basis for making anticipated process improvements and ensures that your innovation has the best chance of success as you bring it to market. 

As red blood cells do not have mitochondria or a Krebs cycle, their energy is derived from glycolysis (ATP production) and from the HMP shunt (NADPH production). Defects either in glycolysis or in the HMP shunt may result in red ceU abnorm ities. Sometimes the defect centers in red blood cells. In other cases, it is more generalized. as glycolysis and the HMP shunt are generalized processes. Conditions that affect glycolysis or the HMP shunt include conditions 1-10). 

C. Occurrence of Product Defects in Full-Scale Production... 

The flow chart of full-scale production is shown in Figure 6. CET slurry at a scale of about 100 L per batch containing 28 kg of CET is turned into a supersaturated solution by the above-mentioned equipment. The solution is filtered by ultrafiltration to remove endotoxins and sterilized by a membrane filter. Seed crystal is added in the sealed condition and then subdivided into vials. All of these procedures are carried out at around 5°C. The vials are frozen in the chamber of the freeze-dryer at 0°C and freeze-dried. Three batches are achieved per day. The mean times required are 25 min (at the longest) from the preparation of the supersaturated solution and 15 min (at the longest) from seeding to freezing, respectively. In our preliminary experiment adequate products were obtained even when the samples were left for 2 h before addition of seed crystal and for 2 h after seeding at standstill condition. No product defect occurred in the first batch of full-scale production. 

The troubles we encountered here were predictable and not so drastic as seen in the eutectic crystalline freeze-drying of CET. As a whole, the production in the commercial size dryer went well but a small number of the vials were moved to secondary drying, holding free water locally due to the variation of freezing or drying as described before. The fortuitous occurrence of product defect such as local evacuation or local high-water-content spot was unavoidable. 

The occurrence rate of product defect was adequately reduced by several improvements in the program but could not be less than a few percent. As mentioned before, LMOX and FMOX were sensitive to water and these defect prod-... 

In practice, FDA only occasionally inspects clinical supply manufacturing sites. However, that should not result in a false sense that an FDA inspection will never take place. Manufacturing sites should always be prepared to undergo FDA inspections. Factors that may cause FDA to inspect clinical supply manufacturers include Review in connection with a preapproval inspection of the commercial manufacturing site routine inspections of contract manufacturers who manufacture only clinical supplies inspections resulting from observed product defects, especially when such defects are linked to adverse reactions in patients (such as contaminated parenterals) in reaction to recalls of clinical supplies or other factors. The FDA inspections of manufacturing operations for clinical supplies used in Phase III trials are more likely than for operations producing Phase I or Phase II clinical trial material. 

Section 211.198 of the GMP regulations sets forth the requirements for reporting and investigating complaints. This section is intended to assure that when a manufacturer is notified of a product defect, a thorough investigation will be performed to determine the cause of the defect, and whether a recall of the product from the marketplace should be initiated. Of course, these activities are all aimed at protection of patients from harm caused by defective products. 

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