Regulatory/GMP Compliance

Manufacturers face uncertainty over imports, regulatory policies, and field inspections.

Although best practices are key, advances in integrated informatics platforms and automation can make it easier to ensure data integrity and improve overall laboratory efficiency.

The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.

The ICH Q11 Q&A discusses the development and manufacture of drug substances and the selection and justification of starting materials.

The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.

The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates,  discusses how to ensure sterility when manufacturing small-scale parenteral batches.

The agency finds repeated CGMP violations at Porton Biopharma, Limited.

FDA cites Sato Yakuhin Kogyo Co., Ltd. with data integrity violations after a June 2016 inspection of its Kashihara City facility.

EDQM outlines the steps it will take to implement the ICH Q3D guideline on elemental impurities.

The agency put Baoying County Fukang Medical Appliance Co., Ltd. on import alert after observing violations at the company’s Yangzhou City facility.

The commission concluded its P4Bio pilot phase with the adoption of the monograph for etanercept.

Biopharma must see regulators as partners in their efforts to provide safe and effective therapies.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on a limited budget.

A consistent approach in assessing risk is an important aspect of successful quality management.

The commission approved future plans, appointed members, and adopted texts during its November 2016 session.

Wockhardt Limited received a warning letter from FDA for CGMP violations.

FDA issued a warning letter to Srikem Laboratories Pvt. Ltd. for data integrity violations

CDER is asking manufacturers to participate in the Experiential Learning Site Visit Program to educate OPQ staff about pharmaceutical manufacturing processes.

The agency published guidance to help pharma companies in the clinical development of treatments for bacillus Calmette-Guerin (BCG)-unresponsive nonmuscle invasive bladder cancer.

At ICH’s November 2016 meeting, the council announced new members and new guidelines.

FDA puts Beijing Taiyang Pharmaceutical Industry Co. on import alert after company refuses access to inspectors.

By working together to harmonize the highly variable steps within the biopharmaceutical manufacturing process, both end users and suppliers are making strides toward the efficiency and integrity of single-use technology.

The Czech Republic drug manufacturer was cited for data integrity and quality issues.

The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.

FDA is working with EMA to treat rare diseases and keep patients involved in healthcare.

Are investigations supporting or hindering performance excellence?

Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.

Plant transient expression offers a flexible approach in drug development and enables rapid production and scale up of therapeutics.

Experts discuss recent advances in cell viability testing methods in bioreactors.