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 ?[…]
This guideline is intended to help in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase I clinical trials. This guidance describes an approach to •Implementation of manufacturing controls that are appropriate Read more about CGMP guidance for Phase I Investigational Drugs[…]
•“ Residual solvents in pharmaceuticals are defined as organic volatile chemicals that are used in the manufacture of drug substances and impurities or excipients, or in the preparation of drug products •Residual solvents refers to the amount not removed during the purification of the product •Residual solvents are one of the three main types of Read more about Residual Solvent Analysis According to USP <467>[…]
ICH Q9 elements of risk management Risk Identification -> Risk Assessment ->Risk Mitigation -> Risk Communication How to identify risk •Theoretical analysis-Science, engineering, or math•Based on experiments-Structured or unstructured experiments-Edge of failure or validation•Statistically derived-Trend analysis FMEA and HACCP FMEA salient features •How can the process fail?-Power outage stops mixing-Wrong valve open sends product Read more about Risk Management for Bio-Pharma ICH Q8 and ICH Q9[…]
Subsystems interacting with The Design Control Process Management Controls Production and Process Controls Corrective and Preventive Action Document and Record Control Labeling and Packaging Control Risk Management Change Control QSIT Design control requirements Your Firm must have a 21 CFR 820.30 compliant design control process prior to submitting a 510(k), as well as during IDE Read more about FDA expectation from you during Design Control portions of Inspections[…]