Bulk pharmaceutical chemical

It is also a guideline to ensure product quahty through the suitabihty of the manufacturing equipment, air and water quahty, sanitation, insect and rodent control, and housekeeping. The FDA periodically sends inspectors to audit chemical companies who manufacture bulk pharmaceutical chemicals or inactive ingredients called excipients to ensure conformance. Whereas GMP conformance ensures that the product meets pharmaceutical quahty standards, it does not ensure conformance to customer-service-related requirements. 

HHS/FDA International Conference on Harmonisation, Guidelines Availability Impurities in New Drug Substances Notice, Federal Register, January 4, 1996 An FDA Perspective on Bulk Pharmaceutical Chemicals, Edmund M. Fry, Pharmaceutical Technology, February 1984, Pages 48-53... 

Medicinal products and bulk pharmaceutical chemicals are produced mainly in batch processes. Controlling these products and chemicals at the end of their manufacturing processes is not in line with the general principle of quality assurance, which is that quality should be built into the product. It is then necessary to ensure that appropriate good manufacturing practices are adhered to throughout the manufacture of both bulk pharmaceutical chemicals (active ingredients as well as excipients) and medicinal products. 

It must be pointed out that GMP guides are not intended to cover health security aspects for the personnel engaged in manufacturing. They may be very important in the manufacture of certain bulk pharmaceutical chemicals or medicinal products, such as cytostatics, antibiotics, or other highly active, biological and radioactive products, but they are governed by other provisions of law. 

Guide to Inspections of Bulk Pharmaceutical Chemicals , 1991, Reference Materials and Training Aids for Investigators, FDA/NAPM, September. 

Pharmaceutical Engineering Guides for New Facilities , 1996 Vol. 1, Bulk Pharmaceutical Chemicals, ISPE/FDA, June. 

Safety Production of the requisite drug molecule, called the active pharmaceutical ingredient (API) or bulk pharmaceutical chemical (BPC), may involve materials, solvents, or intermediates that are volatile, toxic, or even explosive. The development program has to determine the appropriate manufacturing processes to ensure that safety is not compromised and the API can be produced and purified to remove impurities and toxic residues. 

Berry, I.R. and Harpaz, D., Validation of Bulk Pharmaceutical Chemicals, Interpharm Press, Inc., Buffalo Grove, IL, 1997. 

Validation SOPs are written to provide explicit instruction on how to achieve the standards for those responsible for writing and executing master validation plans for drug, drug-device combinations, diagnostics, pharmaceutical biotechnology, and bulk pharmaceutical chemical products. Included is the ready-to-use template so that one can immediately save time and expense without missing any critical elements. 

In its guideline to inspection the FDA set the following criteria to identify an industrial chemical as a bulk pharmaceutical chemical (BPC) (FDA, 1991) ... 

In the mid-1990s the term active pharmaceutical ingredient (API) was introduced by the FDA to replace the term bulk pharmaceutical chemical (BPC). 

The International Pharmaceutical Excipient Council in the United States (Arlington, Virginia 703-521-3338) has issued a GMP guideline for excipient bulk pharmaceutical chemicals. In conjunction with both the European and Japanese Pharmaceutical Excipient Councils, the council is currently engaged in establishing international harmonization excipient monographs for the more popular pharmaceutical excipients. A list of important and popular pharmaceutical excipients is given in Table 1. 

U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration. Guide to Inspection of Bulk Pharmaceutical Chemicals. Washington, DC U.S. Government Printing Office (Sept. 1991). 

PhARMA QC Section, Bulk Pharmaceuticals Committee. Concepts for the process validation of bulk pharmaceutical chemicals. Pharm Tech Eur 6(l) 37-42 (Jan. 1994). 

W.E. Hall, Validation of cleaning processes for bulk pharmaceutical chemical processes. Cleaning Validation—An Exclusive Publication, Institute of Validation Technology, 1997. 

Most firms have specific start and stop points for abatch of product and typically equipment is cleaned between batches. Some firms, such as bulk pharmaceutical chemical companies, conduct campaigns. Campaigning is the act of continuous use of equipment to produce numerous lots of the same or different product. An example would be the use of a blender in which... 

TR 28 Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals, 2006... 

PDA (2006),Technical Report 28, Process simulation testing for sterile bulk pharmaceutical chemicals. 

This case study discusses the validation of Programmable Logic Controllers (PLCs) and the particular requirements within a bulk pharmaceutical chemical enviromnent. Emphasis is on bespoke systems, but the requirements of prebuilt PLC package systems are discussed in the section on embedded PLCs. 

PhRMA quality committee, bulk pharmaceuticals working group. PhRMA Guideline for the Validation of Cleaning Procedures for Bulk Pharmaceutical Chemicals. Pharm. Technol. 1997, 21 (9), 56-73. 

Both are legal instruments, both are recognized in the laws of countries other than those of origin, both establish standards for dosage forms as well as for bulk pharmaceutical chemicals. Both use experts from industry, academia, and government at all stages of standards development. Also, for most of its history, the British Pharmacopeia was not a direct government effort. 

Concomitant components Bulk pharmaceutical chemicals (frequently referred to as API in the pharmaceutical industry) may have concomitant... 

Ordinary impurities The types of impurities in bulk pharmaceutical chemicals that are harmless by virtue of having no serious undesirable biological activity in the amounts present are specified as ordinary impurities. 

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