Vendor quality

Involve technical staff in software vendor quality audits. 

Various types of validation generally required in biopharmaceutical manufacturing include process validation, facility and equipment validation, analytical method validation, software validation, cleaning validation and expression system characterization. Combined with other elements of cGMP, including lot release testing, raw material testing, vendor quality certifications, and vendor audits, the quality of product can be consistently assured. 

Material and welding quality inspections, based on industry standards, are desirable. Again, API gives some guidance. Beyond this, the inspection method and acceptance criteria must be clearly stated. In preparing his bid, the vendor must understand exactly what is desired. 

Quality control is also the term used as the name of a department. In most cases Quality Control Departments perform inspection and test activities and the name derives from the authority that such departments have been given. They sort good products from bad products and authorize the release of the good products. It is also common to find that Quality Control Departments perform supplier control activities, which are called Supplier Quality Assurance or Vendor Control. In this respect they are authorized to release products from suppliers into the organization either from the supplier s premises or on receipt in the organization. 

Subcontractor/supplier performance will be evident from audit reports, surveillance visit reports, and receipt inspections carried out by you or the third party if one has been employed. You need to examine these documents for evidence that the subcontractor s quality system is controlling the quality of the products and services supplied. You can determine the effectiveness of these controls by periodic review of the subcontractor s performance what some firms call vendor rating . By collecting data on the performance of subcontractors/suppliers over a long period you can measure their effectiveness and rate them on a scale from excellent to poor. In such cases you should measure at least three characteristics quality, delivery, and service. Quality would be measured by the ratio of defective conforming products received delivery would be measured by the number of days early or late and service would be measured by the responsiveness to actions requested by you on scale of excellent to poor. The output of these reviews should be in the form of updates to the list of assessed subcontractors/suppliers. 

Based on the requirements of the separation, media of suitable pore size, particle size, and surface properties are selected as well as column dimensions and column material. In some cases a suitable combination of media type and column dimensions may be available as a prepacked column. In most cases, this is a more expensive alternative to preparing the column yourself but will provide a consistent quality as assured by the manufacturing and testing procedures of the vendor. The consistent quality may be critical in obtaining reproducible results and may thus be a cost-effective solution. Also, the fact that smaller particle-sized media are more difficult to pack and require special, and expensive, equipment has resulted in that gel filtration media of small particle size, e.g. smaller than 15 /zm, are predominantly supplied as prepacked columns. 

The first step in E-cat testing is to bum the carbon off the sample. The sample is then placed in a MAT unit (Figure 3-13), the heart of which is a fixed bed reactor. A certain amount of a standard gas oil feedstock is injected into the hot bed of catalyst. The activity i.s reported as the conversion to 430°F (221°C) material. The feedstock s quality, reactor temperature, catalyst-to-oil ratio, and space velocity are four variables affecting MAT results. Each catalyst vendor uses slightly different operating variables to conduct micro activity testing, as indicated in Table 3-2. 

For example, a catalyst with a MAT number of 70 vol% and a 3.0 wt% coke yield will have a dynamic activity of 0.78. However, another catalyst with a MAT conversion of 68 vol% and 2.5 wt% coke yield will have a dynamic activity of 0.85. This could indicate that in a commercial unit the 68 MAT catalyst could outperform the 70 MAT catalyst, due to its higher dynamic activity. Some catalyst vendors ha% c begun reporting dynamic activity data as part of their E-cat inspection reports. The reported dynamic activity data can vary significantly from one test to another, mainly due to the differences in feedstock quality between MAT and actual commercial application. In addition, the coke yield, as calculated by the MAT procedure, is not very accurate and small changes in this calculation can affect the dynamic activity appreciably. 

Plot properties of the fresh and equilibrium catalysts ensure that the catalyst vendor is meeting the agreed quality control specifications. Verify that the catalyst vendor has the latest data on feed properties, unit condition, and target products. Verify the fresh makeup rate. Check for recent temperature excursions in the regenerator or afterburning problems. 

Traditionally, the mix of pretreatment equipment required to meet a specific FW volume and quality specification is provided as a permanent installation under a capital project, although today there is a growing global market in outsourced water services. Typically, vendors such as Ecolochem, Inc., a world leader in this type of service, provide trailer-mounted, mobile water-processing equipment that can be... 

Following the Demlng philosophy, each level depends on those below it in a vendor relationship. Thus, quality assurance is effective only if each level performs in an effective manner. 

Monitoring programs must have their own quality assurance programs. These may be called project quality assurance plans or protocols for specific purposes O). If reliable vendors of services are used, the bulk of the quality assurance effort can be placed on those activities unique to the program. Without reliable vendors, QA efforts will be ineffective since it is not cost effective to police quality assurance practices at all lower levels nor to screen all data for its validity. 

The program must require the vendors to measure a number of reference samples and/or duplicates submitted in a planned sequence. It should require prompt measurement and reporting of these data and should maintain the results in a control chart format. Prompt feedback and follow-up of any apparent data discrepancies and reconciliation of the results with control charts maintained by the vendors are required to minimize the length of uncertain performance. The quality assurance plan should include random sampling of the vendors data for their validity and conformance with quality assurance requirements. If quality assurance is properly practiced at all levels, an inspection of 5 percent of the total data output should be adequate. 

The program quality assurance plan may need periodic or emergency revisions Ongoing review of the data should reveal whether any deficiencies are due to Inadequate performance of vendors or to defects In the quality assurance plan Defects In the plan could result from Inadequate quality assessment techniques If measured levels of contaminants were significantly different from anticipated levels, for example ... 

Develop policy-supporting SOPs on computer systems. These may include development, testing, maintenance and support, quality assurance, change control, source code management, system retirement, retrospective evaluation, evaluation of vendor-supplied systems, etc. 

Risk is not minimized because applications are vendor supplied. The level of understanding and incorporation of regulatory expectations varies among vendors. An assessment of the vendor s quality practices should be conducted. 

This was probably the most difficult chapter to put together in this book. For many people who use NMR spectrometers, there will be little (or no) choice about parameters for acquisition - they will probably have been set up by a specialist to offer a good compromise between data quality and amount of instrument time used. This could make this chapter irrelevant (in which case you are welcome to skip it). But if you do have some control over the acquisition and/or processing parameters, then there are some useful hints here. This brings us on to the next challenge for the section - hardware (and software) differences. You may operate a Bruker, Varian, Jeol or even another make of NMR spectrometer and each of these will have their own language to describe key parameters. We will attempt to be vendor neutral in our discussions and hopefully you will be able to translate to your own instrument s language. 

The hermeticity of the end seals of the capacitor. No joint is one hundred percent perfect, and some evaporation will take place slowly over time. We see the need to pick a vendor with a high (and consistent) quality. Yes, in principle, we could try to seal the capacitor totally, say by immersing it in a bath of epoxy-resin/ superglue for example But such capacitors are designed to vent under high pressure (much like a pressure cooker). However, I must tell you that despite all that safety chatter, I have seen some capacitors explode furiously. Remember, it once happened to me in Bombay ... 

Equipment Others, Vendors Two different vendors of the same quality equipment... 

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