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New EU GMP Annex 11:


Project Phase

Operational Phase

Table 1: Risk based Approach

Table 2: Suppliers and Service Providers

Table 3: Comparison of Annex 11 versions

Check Your Knowledge






The Project Phase section of annex 11 is completely dedicated to validation.


Notwithstanding the possibility to leverage system life cycle documentation supplied by the supplier for the VALIDATION, Annex 11-01-2011 stresses the responsibility of the regulated user demanding “Manufacturers should be able to JUSTIFY their STANDARDS, PROTOCOLS, ACCEPTANCE CRITERIA, procedures and records based on their risk assessment.” This applies equally to COMMERCIAL OFF-THE-SHELF PRODUCTS as well as BESPOKE OR CUSTOMISED COMPUTERISED SYSTEMS. The requirement that “Documentation supplied with commercial off-the-shelf products should be reviewed by regulated users to CHECK THAT USER REQUIREMENTS ARE FULFILLED” implicates that URS should be formally available not only for GAMP category 4 and 5 but also for GAMP category 3 systems. By the way this request is in line with the 2001 US FDA draft Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures: Validation validation_cfr11. Though this guidance has been withdrawn in 2003 the sentence “Without first establishing end user needs and intended uses, we believe it is virtually impossible to confirm that the system can consistently meet them” is still logical and therefore remains valid. Of course this does not impy that the URS for GAMP category 3 systems need to be as detailed as specifications for bespoke systems; however the need to indicate which functionality is required and critical to GMP.
Compared to the 2008 draft the level of detail concerning validation has been cut in half. Detailed requirements for validation of database based/inclusive systems and spreadsheets have been removed. However this does not mean that those requirements in the 2008 draft for spreadsheets need not be considered. In line with the 2008 draft PharmAdvice strongly recommends that “Spreadsheets should be suitably checked for accuracy and reliability and stored in a manner which ensures the appropriate version control. The calculations should be secured in such a way that formulations are not intentionally or accidentally overwritten. … Formulations should also be protected from accidental input of in appropriate data type…”.
Concerning testing the new annex 11 emphasizes the requirement to include negative testing demanding “Evidence OF APPROPRIATE TEST METHODS and test scenarios should be demonstrated. PARTICULARLY, SYSTEM (PROCESS) PARAMETER LIMITS, DATA LIMITS AND ERROR HANDLING should be considered.”