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