Quality by Design

Regulatory Harmony

August 02, 2019

Pharmaceutical Technology Europe

Harmonization of regulatory guidelines not only reduces workloads for manufacturers and regulators but can potentially help to accelerate patient access to vital therapies.

AQbD, the Evolution of Pharmacopoeial Standards?

July 17, 2019

MHRA has launched a consultation to gain a greater understanding of the potential application of AQbD in pharmacopoeial standards and the future of medicines standards.

Improving Prospective Product Development Methods Derived from Management-Based Regulatory Guidelines

July 02, 2019

To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures.

Is it Time to Update cGMPs?

July 02, 2019

Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?

Continuous Manufacturing: Addressing the Tough Questions

June 04, 2019

Although continuous approaches offer significant benefits for some products and processes, batch manufacturing is not going away any time soon.

Batch or Continuous? Ask the Right Questions During Scale Up

June 02, 2019

Continuous manufacturing may offer huge opportunities, but it will not be right for every facility or product.

Modified-Release Formulations: Improving Efficacy and Patient Compliance

April 01, 2019

Modified-release oral dosage forms can offer benefits to both formulation scientists and patients.

Strategic Screening for Solubility Solutions

March 02, 2019

Understanding the API, delivery mechanism, and excipient functionality is essential to solving drug solubility challenges.

Dr. Reddy’s Embarks on New Quality Improvement Programs

February 06, 2019

Radha Iyer, vice-president and head of Quality and Scientific Affairs, Global Developed Markets, Dr. Reddy’s Laboratories, discusses new initiatives at the company.

Process Development Best Practices for Topical Drug Products

February 02, 2019

Using a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.