ASTM E2656 - 16 - Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute

ASTM E2656 - 16

Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute

Status : Current   Published : November 2016

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PDF

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HARDCOPY



1.1 This practice establishes an approach to the real-time release testing (RTRT) of pharmaceutical water based on the total organic carbon (TOC) attribute using on-line total organic carbon (OLTOC) instrumentation that is in agreement with current regulatory thinking.

1.2 This practice is harmonized with or supports the concepts of relevant ASTM International Committee E55 on Manufacture of Pharmaceutical Products standards, ICH Harmonized Tripartite Guidelines, the U.S. FDA PAT Guidance, and U.S. FDA Pharmaceutical cGMPs.

1.3 This practice does not provide general guidance information for pharmaceutical procedures that are considered standard practice in the pharmaceutical industry. This practice provides specific guidance for non-standardized procedures.

1.4 This practice does not address the user’s various internal procedures for risk, change, or quality management systems. The overall project effort associated with this practice shall be proportional to the overall risk of failing the pharmaceutical water’s TOC concentration specification.

1.5 This practice does not purport to establish how to comply with pharmacopeias. The RTRT methodology selected must assure compliance with the user’s current required pharmacopeias. However, compliance with pharmacopeia TOC methods is not necessarily sufficient to meet current regulatory expectations for RTRT.

1.6 This practice does not purport to substitute for or replace compendial bioburden testing requirements. It is strictly applicable to the TOC attribute of water quality.

1.7  This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.




Standard NumberASTM E2656 - 16
TitleStandard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
StatusCurrent
Publication Date01 November 2016
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors Biopharmaceutical manufacturing, Chemical analysis, Industrial water, Organic matter content, Pharmaceutical water, Total organic carbon content
ICS11.120.10
PublisherASTM
FormatA4
DeliveryYes
Pages8
File Size299 KB
Price£40.00


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