Validation Master Plan
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Validation Master Plan (VAMP)

Stability Study Program / Plan
New Document

  189.– EUR *
(appr. 284.- 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
     
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General Rules for Laboratories Operating under Good Laboratory Practice (GLP)
New

  130.– EUR *
(appr. 195.- 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
     
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Site master file (SMF) for drug products   230.– EUR *
(appr. 345.- 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      
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Site master file (SMF) for API - drug substances   230.– EUR *
(appr. 345.- 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      
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Dossier-Maître Site (Site Master File) - Version Français   230.– EUR *
(appr. 345.- 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      
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21 Part 11 compliance plan   230.– EUR *
(appr. 345.- 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
     
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Validation master plan for solid and semi-solid manufacturers
Updated Version

  195.– EUR *
(appr. 293.- 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
     
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Validation master plan drug substance manufacturing (API)   160.– EUR *
(appr. 240.- 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
     
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Qualification master plan for refrigerated shipment   175.– EUR *
(appr. 263.- 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
     
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* plus 19% tax for customers from germany
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