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Validation Master Plan (VAMP)



	Stability Study Program / Plan New Document		189.– EUR * (appr. 257.- USD)
	A main GMP requirement for GMP regulated active pharmaceutical ingredients (APIs) and drug products (DPs) is the need of a written stability program / plan. The results of the stability testing are to be used in determining appropriate storage conditions and a product's expiration date. The WHO as well as the ICH have issued various guidelines for ... » all details



	General Rules for Laboratories Operating under Good Laboratory Practice (GLP) New		130.– EUR * (appr. 177.- USD)
	The principles of GLP (Good Laboratory Practice) should be applied in laboratories conducting safety and pre-clinical studies. They are describing a set of rules and basic requirements for a quality assurance system for non-clinical and environmental safety studies, specifically focusing on how to plan, to perform and to monitor GLP studies and how ... » all details



	Site master file (SMF) for drug products		230.– EUR * (appr. 313.- USD)
	The drug product SITE MASTER FILE (SMF) is the site’s most important GMP document and provides a general overview of the site and its operations. On 5 November 2002, the guidelines for the preparation of a SITE MASTER FILE (first edition, April 2000) were replaced by the PIC/S explanatory notes for industry on the preparation of a site master ... » all details



	Site master file (SMF) for API - drug substances		230.– EUR * (appr. 313.- USD)
	The active pharmaceutical ingredient (API) SITE MASTER FILE (SMF) provides a general overview of the site and its operations. A SITE MASTER FILE is prepared by the manufacturer and contains specific and factual GMP information about the production and/or control of API manufacturing operations at the named site and any closely integrated operations ... » all details



	Dossier-Maître Site (Site Master File) - Version Français		230.– EUR * (appr. 313.- USD)
	Le DOSSIER –MAITRE SITE d’un médicament (DMS) est le document BPF le plus important pour un site. Il donne une vision générale du site et des opérations qui y sont mises en œuvre. A partir du 5 novembre 2002, les Recommandations pour la Préparation d’un DOSSIER ... » all details



	21 Part 11 compliance plan		230.– EUR * (appr. 313.- USD)
	Ensure compliance with CFR 21 Part 11 (EU GMP Annex 11) by establishing a clearly defined plan. You do not have to be a specialist in computerised systems to help your company meet the US FDA regulatory requirements of 21 CFR Part 11. We have developed a master plan that enables you to initiate and coordinate all crucial Part 11 compliance activities. ... » all details



	Validation master plan for solid and semi-solid manufacturers Updated Version		195.– EUR * (appr. 265.- USD)
	The validation master plan (VMP) is a crucial documents as it describes the basic concept for your overall site validation program. This 25-page VMP template for manufacturers of tablets, capsules, ointments, gels, creams and inhaled products, which has been updated in line with current industry standards, needs only a small amount of site-specific ... » all details



	Validation master plan drug substance manufacturing (API)		160.– EUR * (appr. 217.- USD)
	The validation master plan (VMP) is a crucial document as it describes the basic concept for your overall site validation program. This 26-page VMP template for manufacturers of drug substances/active pharmaceutical ingredients, which has been updated in line with current industry standards, needs only a small amount of site-specific modification ... » all details



	Qualification master plan for refrigerated shipment		175.– EUR * (appr. 238.- USD)
	Have you thought about qualifying your cold chain transportation? Professional cold chain management practices are vital for ensuring product quality and patient safety. We have compiled a 10-page qualification master plan that is available for all customers operating in a GMP and Good Distribution Practices (GDP) environment. The ready-to-use ... » all details

* plus 19% tax for customers from germany


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