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

Topic

Articles

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.

Francesca Speroni is project leader at PTM Consulting and is a member of the AFI process validation working group.

Ilaria Franceschini is in Pharmaceutical Technology at Italfarmaco and is a member of the AFI process validation working group.

Maurizio Valleri is in Pharmaceutical Technology at Menarini and is a member of the AFI process validation working group.

Mauro Silvestri is in Manufacturing Technology at Angelini and is a member of the AFI process validation working group.

Matteo De Nigris is part of Manufacturing Science and Technology at LEO Pharma Manufacturing and is a member of the AFI process validation working group.

in R&D CMC at Chiesi and is a member of the AFI process validation working group.

Alessia Garavaglia is in Good Engineering Practices at Grünenthal and is a member of the AFI process validation working group.

 at Mipharm and is a member of the AFI process validation working group.

Rosa Terribile is in QA at Mipharm and she is a member of the AFI process validation working group.

Stefano Pompilio is in Clinical Trial Manufacturing at Thermo Fisher Scientific and is a member of the AFI process validation working group.

Enrico Modena is in R&D at PolyCrystalLine and is a member of the AFI process validation working group.

Stefano Selva is in Pharmaceutical Technology at Recordati and is a member of the AFI process validation working group.

Lorenza Broccardo is project manager at S-IN Soluzioni Informatiche and is a member of the AFI process validation working group.

Cesare Armetti is an AFI member and participates in the AFI process validation working group.

 is an AFI member and participates in the AFI process validation working group.

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.

Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms

William J. Lambert, PhD, is principal, Module 3 Pharmaceutical Consulting, Incline Village, NV.

For planned acquisitions or licensing, careful analysis of CMC factors ensures no problem areas are overlooked.

Margaret M. Faul is vice-president, Drug Product Technologies, Process Development, Amgen.

Carl L. McMillian is vice-president, Toxicology, Drug Disposition, PK/PD, Eli Lilly and Company.

Pierre Boulas is executive director, Product and Technology Development, Biogen.

Reginaldo A. Saraceno is director, Material and Analytical Sciences, Boehringer Ingelheim Pharmaceuticals.

Mary Devlin Capizzi is partner, Faegre Drinker Biddle & Reath LLP.

Maureen T. Cruz is senior manager, Science, Regulation and Policy, Faegre Drinker Biddle & Reath LLP.

The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.  

Viewpoint: Precompetitive Collaboration Drives Pharma Industry Innovation

Norm Howe is senior partner, Validation & Compliance Institute.

Building employee participation and forming good habits contribute to a company-wide quality culture that pays off.

Strong Quality Culture: A How-To for Busy Managers

The UK's MHRA has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium of regulators.

MHRA Joins the Australia-Canada-Singapore-Switzerland Consortium

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Resources, Guidelines, and Guidance Documents

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

Regulatory and Standard Setting Organizations

The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.

FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines

The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.

EMA Confirms Standards for COVID-19 Treatment Evaluations

The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.

Regulatory Review of COVID-19 Vaccine Begins in Europe

The agency published recommendations for the development of drugs and biologics for the adjuvant treatment of renal cell carcinoma.

FDA Guidance on Treatments for Renal Cell Carcinoma

Automation, digitalization, and supply-chain strategies help mitigate vulnerabilities in both autologous and allogeneic cell therapy manufacturing.

Navigating Cell Therapy Manufacturing Amid Pandemic Woes

Symbiosis has successfully completed a scheduled inspection by MHRA.

Symbiosis Successfully Completes MHRA Audit Inspection

Fill/finish inspection for vaccine vials and syringes must remain GMP-compliant while aiming for fast, efficient methods.

Quality/GMPs

Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?

Due Diligence Assessment of CMC Activities