Additional Guidelines

USP 1078 provides the following guidelines for the excipient manufacturer and the purchaser to use in establishing standards for excipient materials provided. 

The manufacturer and user should mutually agree upon the excipient specifications. The manufacturer must have the facility and process capability to consistently meet the mutually agreed upon specifications of the excipient(s). Subcontracting or significant changes to a supplier s audited process that could affect the physical, chemical, or functionality of the excipient in a final dosage form should be immediately communicated or pre-approved as mutually agreed upon between customer and supplier. 

The purchaser should verify that the supplier of raw materials, components, and services for the manufacture of excipients has the capability to consistently meet the agreed-upon requirements. This may include periodic audits of the vendor s plant, if deemed necessary. Purchasing agreements should contain data clearly describing the product ordered, including where applicable, the following  

The manufacturer should establish and maintain procedures for verification, storage, and maintenance of customer supplied products intended for incorporation into the 

When parked, shut off the key and lower the load. Be sure the unit or load is not blocking a doorway, emergency equipment, or an aisle. Be sure to remove the key to prevent unauthorized use of the walkie truck. 

Take advantage of mirrors mounted on walls, beams, etc., to prevent incidents. Obey safety signs posted throughout the building. 

Ensure regularly scheduled maintenance is performed on the truck. 

Operators should not wear headsets to listen to music. 

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A flare performance chart for the hydrocarbon being flared, should be consulted for additional guidelines on flare tip design. Figure 3 provides a provisional performance chart for propane. The chart defines the design envelop of exit velocities and steam ratios necessary to avoide smoke formation, excessive noise, flame boilover and flame lift-off. 

If the isolate is determined to be vancomycin-resistant, it is most important to know the exact species because some of the treatment options, such as quinupristin/dalfopristin, are not active against E. faecalis. Currently, the treatment options for vancomycin-resistant enterococci (VRE) are not well established by clinical studies or patient experience. The treatment recommendations for vancomycin-resistant E. faecium include linezolid or quinupristin/dalfopristin for a minimum of 8 weeks. However, newer agents, such as daptomycin, may provide another option for treatment for either enterococci species (E. faecium and E. faecalis). Additionally, guidelines suggest the use of imipenem-cilistatin plus ampicillin or ceftriaxone plus ampicillin for the treatment of E. faecalis with a minimum of 8 weeks of therapy. Consultation with an infectious diseases specialist is recommended. 

Additional guidelines on pharmaceutical cleanroom classifications (which became effective on January 1, 1997, for Europe) are contained in Ref. 263. 

An additional guideline, ICHS7B, is in preparation which will address the assessment of potential for QT prolongation. In the meantime, CPMP 986/96 indicates the following preclinical studies should be conducted prior to first administration to humans ... 

This section directs you to sources which either publish fact sheets or can help you find additional guidelines on topics related to isobutyryl-CoA dehydrogenase deficiency. Due to space limitations, these sources are hsted in a concise manner. Do not hesitate to consult the following sources by either using the Internet hyperlink provided, or, in cases where the contact information is provided, contacting the pubhsher or author directly. 

Since that time we have seen numerous additional guidelines on specific statistical issues, for example the European (CPMP/CHMP) Points to Consider Papers ... 

Additional guidelines that are similar to those for composite plate structures are also provided in Reference [5]. 

Additional guidelines outline the need for reserve samples [33], expiration dating [34], and laboratory recordkeeping [35]. 

The plan is only applicable to batches of one particular size, so procedures for scale-up or scale-down of this sampling plan to other batch sizes must be provided. If samples are to be pooled, a justification must be given. Additional guidelines have been developed for determining whether a production lot is wellmixed or segregrated and for the estimation of the sample size and number [2]. 

Additional guidelines about ammonia shipments are given in References 57 and 74. 

In the guideline on SmPC the exact layout and the contents are defined. Additional guidelines issued by central bodies as well as national regulatory authorities provide recommended wording for specific text in various different classes of medical products in the jurisdiction of the RA (e.g. the MHRA document generic overdose sections for selected SmPCs, Feb 2004). 

Additional guidelines for organizations performing in vivo bioequivalence studies... 

An investigation curriculum would include a review of the visitation SOP, the company s policy on cooperative selfregulations and a few additional guidelines. For example ... 

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