Quality control method

STANDARD PROCEDURES FOR VALIDATION OF DRUG QUALITY CONTROL METHODS... 

The technical package may specify a scope and frequency for periodic audits and performance criteria that could lead to changing the audit frequency. It may be a general safety and environmental performance audit or a special audit for items such as raw material storage and handling, quality control methods and documentation. The proprietary nature of a process or product or the complexity of the toll could be a reason to establish a more frequent audit schedule for certain tolls. Audits can also be conducted to follow-up on previously identified shortcomings to document that they were addressed properly. 

Quality Control Methods in Frozen Food Production and Distribution... 

The effects of microsphere size distribution, drug/polymer ratio, and microsphere quality can be easily demonstrated in this laboratory model. Furthermore, as animal data and human clinical trial results are available the model becomes quite useful as a quality control method (46). 

Table 6.5. Comprehensive List of EPA Quality Control Methods that Apply to Situations vrithin and Outside the Petroleum Refining Industry...

M. Baranska, H. Schulz, S. Reitzenstein, et al.. Vibrational spectroscopic studies to acquire a quality control method of Eucalyptus essential oils. Biopolymers, 78, 237-248 (2005). 

The application of chemometrics to these problems includes three segments analytical quality control method and data base development and modeling Aroclor composition and PCB residues in bird eggs. 

Badger, J. and Hendle, J. (2002). ReUable quality-control methods for protein crystal structures. Acta Crystulhgr. 0 58,284-291. 

Because Taguchi has made no immediate coupling between the concept of loss-functions (the more philosophical part) and the off-line quality control methods (the more concrete part), the loss functions probably serve best as an important background concept rather than a practical working tool. 

Expert systems, however, have their disadvantages. Perhaps the most significant one is that it is hard to prove rigorously that they will not give an unexpected behavior. This causes production and quality control organizations to be reluctant to adapt to the methods. Writing a specification for expert system control is less exact and, therefore, more difficult to adapt to quality control methods that were developed for time-temperature-based plans. The... 

Anon. Quality Control Methods for Medicinal Plant Materials. Geneva, Switzerland World Health Organization, 1998. 

The key parameter for any drug product is its efficacy as demonstrated in controlled clinical trials. The time and expense associated with such trials make them unsuitable as routine quality control methods. Therefore, in vitro surrogate tests are often used to assure that product quality and performance are maintained over time and in the presence of change. A variety of physical and chemical tests commonly performed on semisolid products and their components (e.g., solubility, particle size and crystalline form of the active component, viscosity, and homogeneity of the product) have historically provided reasonable evidence of consistent performance. More recently, in vitro release testing has shown promise as a means to comprehensively assure consistent delivery of the active component(s) from semisolid products. 

Nowadays, 3 P-NMR (nuclear magnetic resonance) is sometimes proposed as a better alternative, because this technique requires only a minimum amount of sample pretreatment (12-14). In our opinion, its high investment cost and need for highly qualified operators will cause P-NMR to remain a research technique rather than a quality-control method. However, being an absolute technique, P-NMR seems ideally suited to certify the composition of standard solutions whose quality largely determines the accuracy of both TLC and HPLC results (15,16). 

Classic quality control methods normally focus on specification testing of the final product. There may be some concern about controlling the products only with the specification testing of final products (i.e., it should also be required to incorporate the in-process control parameters, such as the specification of starting material and operation condition of equipment for manufacture). These concerns include the following ... 

Christensen, S.L., Anglov, J.T.B., Christensen, J.M., Olsen, E. and Poulsen, O.M. (1993) Application of a new AMIQAS computer program for integrated quality control, method evaluation and profidency testing. Fresenius Journal of Analytical Chemistry, 345, 343-50. 

D. Andrey, A routine quality control method for the determination of iodine in human and pet food by ICP-MS, Atom. Spectrosc., 22 (2001), 299D305. 

Burr, I., Statistical Quality Control Methods, Dekker, New York, 1976. 

Depending on each of these requirements, a satisfactory separation may be achieved after two or three injections. This is especially so when you are only seeking a profile or looking for a single compound, or where the separation will not become an established quality-control method. Alternatively, more extensive work may be necessary for total resolution of all components or for defining a reproducible control method. 

Blerl-Leonhardt, B. A. Release Rates from Formulations and Quality Control Methods In "Insect Suppression Using Controlled Release Pheromone Systems", Kydonieus, A. F. and Beroza, M. Eds., CRC Press, Boca Raton, FL, In Press. 

Ball, R.W. and Packman, L.C. (1998) Matrix-assisted laser desorption ionization time-of-flight mass spectrometry as a rapid quality control method in oligonucleotide synthesis. 

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