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means having responsibility for maintaining the continued safety, purity, and potency of the product and for compliance with applicable product and establishment standards, and for compliance with current good manufacturing practices., as used in § 601.12 of this chapter, means to evaluate the effects of a manufacturing change on the identity, strength, quality, purity, and potency of a product as these factors may relate to the safety or effectiveness of the product.Patient safety is a key reason for this requirement, dating back to several unfortunate events within the pharmaceutical and food industries.In one incident, the use of an unsuitable RM led to widespread toxicity, resulting in hallucinations and other severe symptoms.An RM qualification and control program is considered a key factor in assuring the quality of medicinal drugs, yet it is often deemed of secondary importance at a busy firm.Usually, RM testing is not considered scientifically challenging or exciting - until, of course, the supply chain is imperiled by a single failure.is interpreted to mean the specific ability or capacity of the product, as indicated by appropriate laboratory tests or by adequately controlled clinical data obtained through the administration of the product in the manner intended, to effect a given result.

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However, it is undesirable to build large warehouses and store huge inventories if materials must be discarded because they expire before use., as used in § 601.12 of this chapter, means the quality standard (i.e., tests, analytical procedures, and acceptance criteria) provided in an approved application to confirm the quality of products, intermediates, raw materials, reagents, components, in-process materials, container closure systems, and other materials used in the production of a product.For the purpose of this definition, means a written communication to an applicant from FDA usually describing all of the deficiencies that the agency has identified in a biologics license application or supplement that must be satisfactorily addressed before it can be approved.Table 1 summarizes the applicable regulations for pharmaceutical products of various types, and summarizes some of the differences between US and European regulations.These differences may create complex challenges for the firm that manufactures multiple profile classes of products for worldwide sale.means a submission by the biologics license applicant or supplement applicant of all materials needed to fully address all deficiencies identified in the complete response letter. 24, 2005; 73 FR 39610, July 10, 2008; 77 FR 26174, May 3, 2012] This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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