Master Plans

Stability Study Program / Plan

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 produc Show all details

General Rules for Laboratories Operating under Good Laboratory Practice (GLP)

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, Show all details

Site master file (SMF) for drug products

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 b Show all details

Site master file (SMF) for API - drug substances

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 ma Show all details

Dossier-Maître Site (Site Master File) - Version Français

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 Recommandation Show all details

21 Part 11 compliance plan

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 mast Show all details

Validation master plan for solid and semi-solid manufacturers

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 Show all details

Validation master plan drug substance manufacturing (API)

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 Show all details

Qualification master plan for refrigerated shipment

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 Show all details