Data integrity is “The maintenance of, and the assurance of the accuracy and consistency of, data over its entire life cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data. Data integrity is the opposite of data corruption, which is a form of data Read more about Common issues related to data integrity[…]
What is Data Integrity ? The definition of Data integrity is that a data need to be complete, consistent, and accurate . The concept applies to CGMP and Good Clinical Practice (ICH E6). Data should be “ALCOA” ( Attributable, Legible , Contemporaneous, Original or true copy, Accurate ) Key Concepts of Data Integrity: Metadata : Read more about FDA’s Dec 2018 Guidance on Data Integrity[…]
“GxP” is defined as “Good-X-Practice,” based on FDA “Predicate Rules”. The X can be filled by “M” to make GMP = Good Manufacturing Practice, by “L” to make GLP = Good Laboratory Practice, by “C” to make GCP = Good Clinical Practice. GMP: The systems used in quality control laboratories supporting manufacturing operations GLP: The Read more about What is GxP Systems ?[…]
What is OOS ? An explicit set of requirements is called specification and typically it needs to be satisfied by a material, product, or service. So when a material, product or service fail to meet one or more of the applicable specifications, it is referred to as being out of specification, abbreviated as OOS. FDA Read more about Out-of-specification(OOS) , FDA Guidance – Lab Investigation Steps[…]
Layered Process Audits (LPAs) are merely: DAILY CHECKS OF HIGH-RISK PROCESSES and documented with reference to FDA Internal Audit. This is where you actually have various people come and do mini-inspections, mini-audit periodically or may be daily and document that. Here are few of the principles listed out which will help you. Implementation: Consists of Read more about What are Layered Process Audits ?[…]
Pregnant pause is a technique used during FDA inspection so that the answering staff do not answer questions more that required and get in to trouble. Inspectors are very good at asking questions to know details and catch if something is not right during the conversation. It is said that when you are lying you Read more about What is Pregnant pause in FDA Inspection ?[…]