Master Plans
Master Plans
New Document

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 Show all details

200,00 EUR (Non-german customers)
approx. 264.00USD (Non-german customers)
238,00 EUR (German customers incl. 19% tax)
Master Plans
NEW

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, sp Show all details

140,00 EUR (Non-german customers)
approx. 184.80USD (Non-german customers)
166,60 EUR (German customers incl. 19% tax)
Master Plans

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 th Show all details

245,00 EUR (Non-german customers)
approx. 323.40USD (Non-german customers)
291,55 EUR (German customers incl. 19% tax)
Master Plans

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 manufa Show all details

245,00 EUR (Non-german customers)
approx. 323.40USD (Non-german customers)
291,55 EUR (German customers incl. 19% tax)
Master Plans

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 p Show all details

245,00 EUR (Non-german customers)
approx. 323.40USD (Non-german customers)
291,55 EUR (German customers incl. 19% tax)
Master Plans

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 Show all details

245,00 EUR (Non-german customers)
approx. 323.40USD (Non-german customers)
291,55 EUR (German customers incl. 19% tax)
Master Plans
Updated Version

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 upd Show all details

200,00 EUR (Non-german customers)
approx. 264.00USD (Non-german customers)
238,00 EUR (German customers incl. 19% tax)
Master Plans

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 wi Show all details

170,00 EUR (Non-german customers)
approx. 224.40USD (Non-german customers)
202,30 EUR (German customers incl. 19% tax)
Master Plans

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 ope Show all details

185,00 EUR (Non-german customers)
approx. 244.20USD (Non-german customers)
220,15 EUR (German customers incl. 19% tax)
Articles 1 to 9 (of 9) * Additional 19% tax for customers from Germany  1 

On this page you can purchase Validation Master Plans. For more information on what Validation Master Plans also called VAMPs are click here.

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