Regulatory/GMP Compliance

Getting an answer is easy-asking the right question is apparently more difficult.

FDA Publishes Final Guidance on Dissolution Testing.

The Association of the British Pharmaceutical Industry (ABPI) has published a guidance that suggests best practices for managing adverse events and other pharmacovigilance data from the internet and social media tools.

An FDA guidance has provided information for products that involve the application of nanotechnology, and rationales for those points.

FDA Issues Final Guidance to Amend IND Reporting Requirements.

Sometimes, there are just too many cooks in the kitchen.

FDA issued a new guidance for industry concerning the submission of summary bioequivalence data for abbreviated new drug applications.

Many factors affect research results.

FDA recently published guidance for preventing the cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients with nonpenicillin beta-lactam antibiotics.

FDA Released Draft Guidance for Industry on Safety Labeling Changes.

In any industry, inspections can be a pain, and pharma is no exception.

FDA issued a draft guidance for industry on Mar. 11, 2011, titled User Fee Waivers, Reductions, and Refunds for Drug and Biological Products, that offers recommendations to applicants seeking such actions under the Federal Food, Drug, & Cosmetic Act (FD&C Act). A similar draft guidance was issued in July 1993. The new document clarifies the types of waivers, refunds, and reductions available under the user-fee provisions of the FD&C Act as well as the procedures for handling these requests, including how to appeal an FDA decision.

Just when things seem to be looking up, the unexpected problem occurs.

On Feb. 4, 2011, the European Medicines Agency released new document on drug products that are manufactured using stem cells.

The European Medicines Agency has released a new Annex 11-Computerized Systems to its GMP Guide Chapter 4 on Documentation to account for the increased use of and complexity of computerized systems in the drug-manufacturing community.

Taking care to note, file and re-check information can save one from future mishaps.

The author describes why statistical significance would impose an unreasonable burden on manufacturers.

FDA published its long-awaited guidance titled Process Validation: General Principles and Practices this week.

FDA issued a draft guidance for industry on Jan. 18, 2011, about the size of beads within drug products labeled for sprinkle.

Sometimes doing what you think is right ends up being completely and utterly wrong.

The author explains the idea of equivalence and describes how it can facilitate equipment validation.

With the increasing need for businesses to reduce costs and demonstrate value, there is a requirement to look at all aspects of bio/pharma drug development and manufacturing to achieve efficiency improvements.

A case study describes how a software control system can manage training needs across an international company and improve GMP compliance.

Remaining calm, cool, and collected during mergers and inspections is a feat in itself.

The US Food and Drug Administration issued a draft guidance last week on the Qualification Process for Drug Development Tools.

From disagreement to denial, being cordial about quality control can be challenging.

From weekend deliveries to nonsterile gloves, a single exception can make a product fall flat.

The US Food and Drug Administration and European Medicines Agency (EMA) are looking for drug manufacturing companies to participate in their joint good manufacturing practice (GMP) inspection pilot program.

Fallout escalates from McNeil recall and Genzyme shortages as regulators review oversight.