Does Annex 11 apply to medical devices?
Strictly speaking, Annex 11 applies only to medicinal products and not to medical devices. However, forward-thinking device companies may want to align their activities with the guidance.
Where a computerized system replaces a manual operation there should be no resultant decrease in product quality or quality assurance?
Annex 11 states: “Where a computerized system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process.”
What is a computerized system GxP?
GxP Compliance Software. GxP software systems help companies comply with these requirements. GxPs are “good [variable] practices” determined by regulations and standards in different industries. Examples include good manufacturing practices (GMP), good clinical practices (GCP), and good laboratory practices (GLP).
What is the difference between Part 11 and Annex 11?
Annex 11 is a detailed guide to the areas of compliance that need documentation. Annex 11 points to risk assessment as the start of compliance activities. Part 11 differentiates security for open and closed systems, with extra security measures for open systems but without reference to risk or criticality.
What is Volume 9a in pharmacovigilance?
Volume 9 of “The rules governing medicinal products in the European Union” contains Pharmacovigilance guidelines for medicinal products for both human and veterinary use.
What has been omitted in the new annex 11?
Therefore, there have been some changes in the new version of Annex 11 the omission of parallel testing is good and reflects current validation practice. Omitting the ability to validate systems retrospectively may catch slow companies or start-up companies moving from R&D into manufacturing for the first time.
What is the difference between GxP and GMP?
What is GxP? The G stands for “Good” and the P stands for “Practice”. The ‘X’ in the middle is a variable that can be substituted with any word that appropriately completes the acronym. For example, ‘x’ is replaced by ‘M’ to make it GMP which represents ‘Good Manufacturing Practice’.
What do you need to know about Gamp Annex 11?
Revised EU Annex 11 Computerized Systems, including the official GAMP® interpretation of key aspects FDA 21 CFR Part 11 Update, including the current FDA interpretation, and how to meet these requirements in practical and effective ways European and International Requirements for Electronic Records and Signatures
What does Annex 11 say about computerized systems?
Specifically, Annex 11 says computerized systems involved in GMP-regulated activities should be validated. Such activities include, but aren’t limited to: If all this sounds similar to the requirements of the FDA’s 21 CFR Part 11 rules for electronic records and electronic signatures, it should.
How are templates of spreadsheets used in GMP Annex 11?
Templates of spreadsheets help to avoid erroneous calculations from data remaining from previous calculations. They should be suitably checked for accuracy and reliability (annex 11 p7.1). They should be stored in a manner which ensures appropriate version control (chapter 4 p4.1).
Why is Annex 11 important to the EU?
The guidance, called Annex 11, also was revised in response to an alarming number of problems detected in computerized systems. In plain English, Annex 11 wants to ensure the computerized systems you use to manufacture medicinal products have no adverse impact on product quality, product efficacy, or patient safety.