Cleaning validation

Cleaning validation for is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes. All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product.^[1][2]

References

1. ^ "Application of total organic carbon analysis to cleaning validation. PDA J Pharm Sci Technol. 1996 Jan-Feb - PubMed Result". www.ncbi.nlm.nih.gov. http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&uid=8846061&cmd=showdetailview&indexed=google. Retrieved 2008-03-10. 
2. ^ "Establishing scientifically justified acceptance criteria for cleaning validation of finished drug products". cat.inist.fr. http://cat.inist.fr/?aModele=afficheN&cpsidt=2430841. Retrieved 2008-03-10. 

This pharmacology-related article is a stub. You can help Wikipedia by expanding it.v ·

This industry-related article is a stub. You can help Wikipedia by expanding it.v · Categories: Quality Pharmacology stubs Industry stubs Wikimedia Foundation. 2010. Игры ⚽ Нужно сделать НИР? School Without Walls Oxlow Cavern Look at other dictionaries: Validation master plan — The Validation Master Plan also referenced as VMP is one of the key documents in the GMP (Good manufacturing Practice) regulated pharmaceutical industry. Even though it is not mandatory it is the document that outlines the principles involved in… …   Wikipedia Verification and Validation — Verification Validation is the process of checking that a product, service, or system meets specifications and that it fulfils its intended purpose. These are critical components of a quality management system such as ISO… …   Wikipedia Verification and validation — IV V redirects here. For NASA s IV V Facility, see Independent Verification and Validation Facility. Verification and validation is the process of checking that a product, service, or system meets specifications and that it fulfills its intended… …   Wikipedia Verification and Validation (software) — In software project management, software testing, and software engineering, Verification and Validation (V V) is the process of checking that a software system meets specifications and that it fulfils its intended purpose. It is normally part of… …   Wikipedia Parts cleaning — is essential to many industrial processes, as a prelude to surface finishing or to protect sensitive components. Electroplating is particularly sensitive to part cleanliness, since molecular layers of oil can prevent adhesion of the coating. ASTM …   Wikipedia Total organic carbon — (TOC) is the amount of carbon bound in an organic compound and is often used as a non specific indicator of water quality or cleanliness of pharmaceutical manufacturing equipment. A typical analysis for TOC measures both the total carbon present… …   Wikipedia Ion mobility spectrometer — An ion mobility spectrometer (IMS) is a spectrometer capable of detecting and identifying very low concentrations of chemicals based upon the differential migration of gas phase ions through a homogeneous electric field. IMS devices come in a… …   Wikipedia Hydrogen peroxide — IUPAC name …   Wikipedia Currency detector — A currency detector is a device that determines if a piece of currency is, or is not, counterfeit. These devices are used in vending machines that accept payment and dispense a product to a customer. They are also used in change machines and in… …   Wikipedia Data cleansing — Not to be confused with Sanitization (classified information). Data cleansing, data cleaning, or data scrubbing is the process of detecting and correcting (or removing) corrupt or inaccurate records from a record set, table, or database. Used… …   Wikipedia 18+ © Academic, 2000-2024 Contact us: Technical Support, Advertising Dictionaries export, created on PHP, Joomla, Drupal, WordPress, MODx. Mark and share Search through all dictionaries Translate… Search Internet Share the article and excerpts Direct link … Do a right-click on the link above and select “Copy Link”