Continuous Manufacturing and its Regulatory Challenge

So, what is the buzz about continuous manufacturing (CM)? What benefits does it bring to the manufacturer and what are the regulatory challenges? The author of this Contract Pharma article, José L. Toro, Ph.D. of Lachman Consultants, discusses the current thinking on the benefits of CM and the regulatory hurdles a manufacturer has to overcome. [...]

New and Revised Bio Guidances Issued by OGD

The Office of Generic Drugs is publishing thirty-one new and fifteen revised bioequivalence guidances according to the pre-publication notice that appeared in the Federal Register today (here).  The official FR notice is scheduled to publish on September 17, 2019, but a quick check reveals that the new and revised guidance documents are already available today (September 16th) on the Product-Specific Guidances for Generic Drug Development (here).

Bioanalytical Laboratories:  What to Do with Variable Internal Standard Response?

For all Sponsors submitting INDs, NDAs, ANDAs, BLAs, and supplements, and the bioanalytical laboratories analyzing and reporting the data to support these submissions, the FDA just issued its Guidance for Industry, “Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers.”  The Q&A guidance contains five questions, along with the Agency’s current thinking on each topic. 

Glass 3d buttons. Up and down

One Week Left in August – How Do the Approval Numbers Look for Generics?

I don’t know about you but has this year flown by or what?  Summer will be over on Labor Day and there will be only one month left in FY 2019.  OGD approval actions thru reporting on August 22 show OGD with 53 full approval actions and 11 tentative approval actions.  Thus, it looks like OGD will beat the last two fairly slow months that had total approval actions of 62 (45 full and 17 tentative),

Laboratory Instrument Calibration – Are You Covered?

It is paramount that a Quality Control laboratory has a calibration and preventative maintenance program for the laboratory instrumentation so that there is assurance that the instrumentation continues to be “fit for purpose” and that there is confidence in the accuracy and reliability of all analytical instruments.  There should be a controlled, comprehensive list of the instrumentation within the laboratory,

More is Not Always Better – Extra Testing

When it comes to ice cream and desserts, I must admit the more the better in my opinion.  The same, however, doesn’t hold true for laboratory testing and the resultant data.  All testing performed and data generated must be accountable to ensure the integrity of the data.  Performing extra testing, even if with all good intentions,

Child-Resistant Packaging – The FDA Outlines What and How to Label Products

In a Federal Register announcement today (here), the FDA announced the availability of a final guidance entitled Child-Resistant Packaging Statements in Drug Product Labeling.  The guidance provides information on the type of statement that may be made on child-resistant packaging for drug products.

As a reminder, the FDA has not regulated child-resistant packaging since 1973,

Urgent Drug Listing Issue – Check Your Product Status!!!!

Take action now to assure that your facility information, drug listing information, and manufacturing sites are correct and that no changes have been made to any of these items or others that are listed in the FR notice  due to publish on Wednesday (pre-publication notice here).

The Notice indicates registrant’s responsibilities as follows:

Each registrant must list all drugs it manufactures for commercial distribution within 3 days of initial registration (21 CFR 207.45).