How a monograph, general notices, and general chapters relate to good manufacturing practices.

Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?

Careful analysis of CMC factors ensures no problem areas are overlooked.

Due Diligence Assessment of CMC Activities

Online sessions on quality and regulatory practices amid the pandemic, remote monitoring, Annex 1 changes, and more. 

2020 Bio/Pharma Virtual Congress: November 11, 2020 

Topic

Articles

The agency published clinical data on remdesivir and information about COVID-19 treatments that have received scientific advice or informal guidance from EMA’s pandemic Task Force.

EMA Implements Transparency Measures for COVID-19 Medicines

The Center for Drug Evaluation and Research is studying factors that influence the development of generic versions of brand-name drugs.

Predicting Generic Drug Marketing Applications

FDA published guidance for submitting standardized study data in electronic format. 

Guidance on Submitting Standardized Study Data 

The agency, in response to an executive order, published a list of essential medicines, medical countermeasures, and critical inputs that should be available at all times in an adequate amount to serve patient needs.

FDA Identifies Essential Medicines

The agency’s Vaccines and Related Biological Products Advisory Committee met to discuss COVID-19 vaccine approvals, post-marketing safety studies, and ongoing safety monitoring of vaccines.

FDA Vaccine Committee Meets About COVID-19 Vaccines

FDA sent a warning letter to LEC Custom Products for a variety of CGMP violations including use of inappropriate equipment and processes.

FDA Finds CGMP Violations at Canadian Facility 

FDA issued guidance for applicants that must report annually on the status of postmarketing studies and clinical trials under section 506B of the FD&C Act.

Guidance on Annual Status Reports of Postmarketing Studies 

Bio/Pharma companies are galvanized to develop COVID-19 therapies under FDA’s acceleration program.

Bio/Pharma Industry Works Overtime to Find COVID-19 Therapies

Recent industry guidance aims to anchor rapid COVID-19 vaccine development in good manufacturing practice protocols.

GMPs Guide COVID-19 Vaccine Manufacturing

Christopher Burgess is with Burgess Consultancy, "Rose Rae," The Lendings, Starforth Barnard Castle, Co. Durham, DL12 9AB UK.

Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.

Quality/GMPs

Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?

Due Diligence Assessment of CMC Activities

2020 Bio/Pharma Virtual Congress: November 11, 2020