We need your consent to use the individual data so that you can see information about your interests, among other things. Click "OK" to give your consent.
Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
Translate name
STANDARD published on 1.11.2016
Designation standards: ASTM E2656-16
Publication date standards: 1.11.2016
SKU: NS-667334
The number of pages: 8
Approximate weight : 24 g (0.05 lbs)
Country: American technical standard
Category: Technical standards ASTM
Keywords:
ICS Number Code 11.120.10 (Medicaments),13.060.50 (Examination of water for chemical substances)
Significance and Use | ||||||||||||||||||
5.1 Pharmaceutical water is the most common component or ingredient used in pharmaceutical and biopharmaceutical manufacturing. Acceptable purity of the water is important to the quality of the final pharmaceutical product. TOC concentration is a key indicator and attribute of the purity of this water and also an important monitor of the overall performance of the water purification system. TOC analysis is the measurement of all the covalently bound carbon present in the water, not including carbon in the form of carbon dioxide (CO2), bicarbonate icon (HCO5.2 Application of this practice provides pertinent information to make informed decisions on the release of water meeting pharmaceutical TOC concentration specifications. |
||||||||||||||||||
1. Scope | ||||||||||||||||||
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. |
||||||||||||||||||
2. Referenced Documents | ||||||||||||||||||
|
Do you want to be sure about the validity of used regulations?
We offer you a solution so that you could use valid and updated legislative regulations.
Would you like to get more information? Look at this page.
Latest update: 2024-09-01 (Number of items: 2 345 425)
© Copyright 2024 NORMSERVIS s.r.o.