Regulatory/GMP Compliance

The agency recommends to avoid the use of to dibutyl phthalate and di(2-ethylhexyl) phthalate in CDER-regulated drug and biologic products, including prescription and nonprescription products.

FDA has issued a draft guidance to assist applicants in the submission of summary-level clinical-site data.

To ensure the accuracy of scientific testing, protect the subjects to avoid data contamination.

FDA announced the availability of the guidance “Q11 Development and Manufacture of Drug Substances†in the Nov. 20, 2011 edition of the Federal Register.

Even when all is well at the facility, one must expect the worst while braving the elements.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has finalized a risk-based inspection planning tool for inspectorates to use in applying science- and risk-based principles to planning GMP inspections.

IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.

Only the strong survive when it comes to pharmaceutical packaging and shipping.

ISPE has published a new guidance titled ISPE Good Practice Guide: Quality Laboratory Facilities, which defines design guidelines for quality laboratories.

IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.

International trade can be great for business, but breaking border laws can put one in hot water.

Regulatory Roundup: ISPE issues ozone sanitization guidance and EMA amends incident management plan

The authors compare direct combustion with rinse and swab sampling methods.

IQ Consortium representatives explore industry approaches and practices for applying GMPs in early development.

Meticulous system configuration can prevent machines from taking over.

The authors, part of the International Consortium on Innovation and Quality in Pharmaceutical Development (IQ Consortium), explore and define common industry approaches and practices when applying GMPs in early development.

ISPE has issued a guidance that is intended to help companies meet cGMP requirements for packaging, labeling, and warehousing facilities and avoid problems such as product adulteration, product mix-up, label mix-up, and misbranding.

FDA has issued a draft guidance on the labeling of OTC products that contain acetaminophen. The draft guidance would give manufacturers an alternative option to properly clarify the risk of liver damage in OTC acetaminophen-containing products.

IQ Consortium representatives explore industry approaches for applying GMPs in early development.

Careful attention to detail will help to prevent valuable assets from "melting" away.

In July 2012, new pharmacovigilance legislation will come into effect across the EU as a result of changes adopted in 2010, specifically EU Regulation No. 1235 and Directive 84.

IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.

Even the slightest of errors in exponential calculations can cause the biggest of headaches.

It's better to catch costly mistakes in the laboratory before they reach the accounting department.

FDA has released a final guidance describing cGMP for preparing media fills for validation of aseptic preparations for positron emission tomography drugs.

Failure to disclose info may work sometimes, but eventually every question will be answered.

Comparison of the top GMP deficiencies cited by the PIC/S Participating Authorities.

On Mar. 12, 2012, FDA released a draft guidance document for industry direct-to-consumer television advertisements that describes FDA's plans for implementing predissemination review.

FDA has issued a list of planned draft and final guidance documents for release throughout 2012. There are approximately 50 such guidances planned.

In a world where product recalls can mean the end of a company, all batches must be perfect.