Author: admin

Supplier Management Key elements & Guidance

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A Supplier Management Program should have below elements : Definition of the product’s quality requirements Evaluation of alternative suppliers Selection of the most appropriate suppliers Conduct joint quality planning Co-operation during relationship period Validation of conformance to requirements Certification of qualified suppliers Conduct quality improvement plans Creation and use of supplier rating Guidance for Supplier Read more about Supplier Management Key elements & Guidance[…]

V & V Documentation Model – 11 Documents

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There are 11 document types in the basic V&V Documentation model as per “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”, Table 3, May 11, 2005: LOC (Level of Concern: Min, Mod, Maj) SW Description Hazard / Risk Analysis (ISO 14971 / ICH Q9 = recommended       model; ultimately Read more about V & V Documentation Model – 11 Documents[…]

Common issues related to data integrity

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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[…]

FDA’s Dec 2018 Guidance on Data Integrity

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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[…]

What is GxP Systems ?

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“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 ?[…]

Out-of-specification(OOS) , FDA Guidance – Lab Investigation Steps

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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[…]

What are Layered Process Audits ?

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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 ?[…]

What is Pregnant pause in FDA Inspection ?

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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 ?[…]

Anti-bribary provisions in FCPA Act

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1977 Congress passes FCPA act to stop bribery and restore public confidence in U.S. business systems. it has 2 sections Anti -Bribery and accounting provision. Anti-Bribery provison is enforced by DOJ (department of justice) and it helps in Prohibiting corrupt payments (bribes) to foreign government officials, political parties, party officials and candidates in order to Read more about Anti-bribary provisions in FCPA Act[…]

Sponser Meeting with FDA some facts

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There are many meetings which a sponser can have with FDA related to the product being developed and to be approved by FDA. But it can be categorized in to 3 base categories. Type A: Critical Path (Urgent) meetings – Clinical hold, Safety Issues, Site disqualification, etc (within 30 days) Type B: Procedural meetings – Read more about Sponser Meeting with FDA some facts[…]