All about Quality and Compliance
Following are key points need to be followed to have a successful FDA inspection. following people play major role in FDA inspections and hence the roles and responsibilities must be defined well and informed. -Receptionist Maintains a Current Inspection Contact List Actively in Contacting Key Personnel Trained on FDA Inspection SOP Does notReview – FDA Read more about FDA inspection – Effective SOP for participants duty[…]
Forms Commonly Used During FDA Inspections FDA 482 – Notice of of Inspection FDA 483 – List of Observations FDA 484 – Receipt for Samples FDA 463 – Affidavit Special purpose affidavits Various special purpose forms EIR – Establishment Inspection Report FDA 482 – called Notice of inspection FDA Investigators must formally identify themselves by Read more about what is FDA 482 and FDA 484 and other form used in FDA inspection[…]
Scope Computerized systems that contain data that support a marketing application Case histories Analytical test results (e.g., LIMS) Data captured from analytical instruments Electronic transcription of hardcopy source data it Does not apply to Computerized medical devices* Study Protocols •Identify computerized system use within the trial process •Computerized systems must: –Satisfy process requirements defined in Read more about FDA Guidance on Computerized Systems Used in Clinical Investigations[…]
NAI – No Action IndicatedSite is in compliance. No actions or response from site necessaryVAI – Voluntary Action IndicatedViolative practices noted that do not immediately jeopardize subject safety, but require correction action. Response necessary; follow-up inspection possibleOAI – Official Action IndicatedViolations severe enough to warrant immediate administrative actions. Reinspection likely Other InspectionsRoutine GMP auditsDirected audit Read more about FDA inspection & Top Reasons for FDA inspection[…]
This is a collection of facts from different experts and not the whole thing, there might be other dos and don’ts other than these applicable as per particular situation. Dos Present business card Be prepared Be organized Be calm Be professional Be confident Have Scribe present at all times during the interview Leave as soon Read more about Dos and Don’t during and after FDA inspections[…]
see that corrective action taken to correct existing product nonconformity or quality problems and Prevent recurrence of the problem The corrective action should Include explanations for how the firm will meet the requirements for all elements of the CAPA subsystem Gain working knowledge of the firm’s CAPA procedure before beginning evaluation of this subsystem Have Read more about Pointers Inspectors look for during FDA inspection – For CAPA (QSIT)[…]
Q – difference between GMP & cGMP ? Ans -Essentially GMP and cGMP are one and the same with one significant distinction; the “c” denotes current. It is my understanding that the FDA (Food and Drug Administration) included the word “current” to ensure that regulated firms use the most current Good Manufacturing Practices (I believe that Read more about FDA Validation compliance[…]
Q – What would the FDA think about test documents with actual results typed in instead of being handwritten? Details – With global teams we have to do a lot of scanning of documents for pre and post execution review, some would like to type the results and signatures so they can be reviewed more easily Read more about FDA Documentation Compliance[…]
Q – How can you define a varying load in sterilant? Answer -Usually the load selection is done by reviewing all the products in the sterile family and making a judgement. It may be helpful to get a bunch of product samples on a table in the conference room, and have a meeting with the Read more about FDA Compliance General (Med device, Pharma, Biotech)[…]
To ensure that good quality assurance practices are used for the design of medical devices and that they are consistent with quality system requirements worldwide, the Food and Drug Administration revised the Current Good Manufacturing Practice (CGMP) requirements by incorporating them into the Quality System Regulation, 21 CFR Part 820. An important component of the Read more about Guidance document on the management of design and process changes[…]