Please sing to the tune of “Honesty,” by Billy Joel: Nitrosamines, it’s such an ugly word, In pharmaceuticals’ impurity. Nitrosamines are hardly ever good, Now FDA has issued policy. Failure to detect nitrosamines, failure to notify FDA when nitrosamines appear in finished drug products, failure to identify impurities in drugs …
Last month FDA published its 4th annual report on the state of pharmaceutical quality and, needless to say, there were some interesting statistics, particularly for us FDA nerds. Number of Manufacturing Sites and Registered Products The report states that for fiscal year 2021, there were 4,451 CDER …
Things are getting hectic for those of us who advise clients on FDA inspections: FDA is busy addressing its backlog of foreign and domestic inspections. As COVID raged, FDA understandably postponed many GMP (Good Manufacturing Practice) and “Bi-Mo” (Bioresearch Monitoring, usually of sponsors of clinical trials …
Ask and ye shall receive, if yer requests are vocal and repeated, and ye are patient, and willing to accept less than ye ask for. For more than a year we have been asking FDA to initiate virtual or remote inspections of drug manufacturing facilities. FDA …
At a conference sponsored by the Parenteral Drug Association on January 27, speakers demonstrated that: Industry has developed best practices for auditors or regulatory inspectors to conduct virtual inspections of drug-manufacturing facilities (virtual inspections are those in which the auditor or inspector is not physically on-site, …
For over nine months FDA has dithered on whether and, if so how, to conduct remote inspections of drug facilities during the pandemic. On the other hand, many foreign regulatory bodies appear to have implemented just such a system of remote inspections. Has FDA just …
It has been over three months since FDA issued its press releases stating that it was postponing most foreign and domestic facility surveillance inspections (see here and here). Since then, apparently only “mission critical” surveillance inspections have taken place, leaving the bulk of registered facilities …
While it seems like all of FDA is consumed with responding to the current COVID-19 crisis, the agency is still managing to continue its work in other areas. Earlier this week, FDA issued a final guidance, titled Nonbinding Feedback After Certain FDA Inspections of Device …
The last time we blogged on news from a recent pharmaconference.com industry conference about current Good Manufacturing Practice (“GMP by the Sea,” agenda linked here), we provided some cute references to corn pudding recipes (blogpost linked here). Despite universally positive feedback about those culinary diversions, …
At the cGMP conference sponsored by pharmaconference.com earlier this month, FDA’s compliance wing encouraged pharmaceutical companies to ensure that they demonstrate “quality maturity,” and offered specifics about what FDA wants to see. Like my grandmother used to say this time of year about the best …
FDA issued its final Guidance on Data Integrity on December 12. The federal government has sworn off regulating by guidance (see blogpost here about Brand memo). In fact, at the Food and Drug Law Institute (FDLI) Enforcement and Litigation Conference that was occurring simultaneously with …
CDER recently published a new Manual of Policies and Procedures (MAPP 5014.1) for the site selection model used by CDER staff to prioritize manufacturing sites for routine cGMP inspections. The goal of the changes associated with the MAPP is to promote the effective and efficient …
In 2016, FDA published the Q7 cGMP Guidance for Active Pharmaceutical Ingredients. It outlines best practices for everything from quality management issues, personnel, buildings and facilities, equipment and recordkeeping, to validation, change control, complaints and recalls. While it provides very useful information to stakeholders, in …
On January 22, 2013, FDA published its final rule on cGMP requirements for combination products under 21 CFR Part 4. Specifically Part 4.4 provides two mechanisms for combination product manufacturers to comply with the cGMP requirements: either by complying with all the cGMP requirements of …
Earlier this month the FDA recognized the drug inspectorates of Ireland and Lithuania for purposes of the Mutual Recognition Agreement (MRA), and in March of this year, the agency recognized the drug inspectorates of Greece, Hungary, the Czech Republic and Romania. Indeed, it was last October …
