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[…]
California has unique hazardous waste regulations that include, but substantially exceed requirements of the federal Resource Conservation and Recovery Act (RCRA) regulations generally in effect in other states. It is also hard to navigate California’s hazardous waste requirements because of the dramatic differences in substantive requirements, enforced by pervasive local city and county agencies deputized Read more about California Hazardous Waste Regulations[…]
In the European Banking Authority’s (EBA) new Guidelines on Internal Governance the aim is to enhance and consolidate supervisory expectations and improve the implementation of internal governance arrangements for individual institutions and the banking system as a whole It has 6 key sections . 1 -Corporate Structure and Organization The management body should ensure that Read more about EBA Guidelines on Internal Governance[…]
March 4 2013, The FDA issued new guidance governing premarket notification submissions for pulse oximeters. The new guidelines apply to all 510(k) submissions for the non-invasive blood oxygen level and pulse rate measuring devices. In the guidance, the FDA specified new rules for identifying, testing and assuring safety for the systems. The new document overrides the Read more about Guidance on pulse oximeter applications[…]
Yesterday FTC has come up with a set of guidelines for online advertising aiming in particular, to address the myriad questions surrounding the use of such tools as Twitter and Facebook to promote products and disseminate messages.The key question is , FDA going to follow it, copy it if yes to what extent. The various Read more about FTC Online Ad Guidance – what will FDA do ?[…]
The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies for medical devices. The proposed regulation would require that clinical studies conducted outside the United States in support of an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a premarket approval (PMA) application, a Read more about FDA Proposes New Rule for Acceptance of Data from Clinical Studies for Medical Devices[…]
Now EU is mulling ban on virtual currencies and particularly bit coins as it seems there are more chances of irregularities which might happen and antisocial elements can use this route to beat the current regulations. “It’s imperative to move quickly on this issue,” Chantal Hughes, a spokeswoman for Financial Services Commissioner Michel Barnier, said Read more about Virtual currencies, gold, money laundering, regulations etc[…]