In-process materials

Principles in Processing Materials. In most practical apphcations of microwave power, the material to be processed is adequately specified in terms of its dielectric permittivity and conductivity. The permittivity is generally taken as complex to reflect loss mechanisms of the dielectric polarization process the conductivity may be specified separately to designate free carriers. Eor simplicity, it is common to lump ah. loss or absorption processes under one constitutive parameter (20) which can be alternatively labeled a conductivity, <7, or an imaginary part of the complex dielectric constant, S, as expressed in the foUowing equations for complex permittivity ... 

Manufacturing, analytical, and quaUty control procedures are thus estabhshed. Specifications for taw and in-process materials, as well as for final products per USP/NF and in-house standards are also determined. Process and formula vaUdation assures that each technological procedure in manufacture accomplishes its purpose most efficiently, eg, blending times for powdered mixtures in tableting, and that each formula ingredient is present in optimal concentrations (12). Thus, it serves to ensure process control (qv), reproducibiUty, and content uniformity. 

Current Good Manufacturing Practice for Finished Pharmaceuticals, Sampling and Testing of In-Process Materials and Drug Products, (1998), CFR, Title 21, Part 211, Volume 4, Section 211.110. 

Sec. 211.110 Sampling and testing of in-process materials and drug products. 

Sec. 820.80 Receiving, in-process, and finished device acceptance - Establish procedures for testing in-coming goods, in-process materials and finished product and maintain records Sec. 820.86 Acceptance status - Disposition of products shall be clearly displayed, e.g. on hold, approved, reject. 

In-process material means any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product. 

Determination of conformance to written specifications and a description of sampling and testing procedures for in-process materials. Such samples shall be representative and properly identified. 

Animals used in testing components, in-process materials, or dmg products for compliance with 59... 

Specific identification of each batch of component or in-process material used ... 

A complete record of all data secured in the course of each test, including all graphs, charts, and spectra from laboratory instrumentation, properly identified to show the specific component, dmg product container, closure, in-process material, or drug product, and lot tested. 

Startup following maintenance produced process upset in reactor, water found in process materials, reflux line blocked resulted in overheating in reactor. 

Organization and personnel describe that in the dispensing of all prescriptions, the pharmacist has the responsibility and authority to inspect and approve or reject all components, drug product containers, closures, in-process materials, and labeling. It also has the authority to prepare and review all compounding records to assure that no errors have occurred in the compounding process. The pharmacist is also responsible for fhe proper maintenance, cleanliness, and use of all equipmenf used in prescription compmmding practice. 

Equipment used in the compounding of drug products shall be of suitable composition so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive affecting the safety, identity, strength, quality, or purity of the drug product. 

Feed water for boilers supplying steam that contacts components, in-process materials, drug products, and drug product contact surfaces shall not contain volatile additives such as amines or hydrazines. 

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