Development

Richard J. Forsyth is principal consultant with Forsyth Pharmaceutical Consulting, 907 Shamrock Ct, Royersford, PA 19468, tel. 484.535.1688, forsythpharmaconsulting@gmail.com.

Dr. Sabine Imamoglu is Product Supply, Pharmaceuticals, Pharmaceutical Affairs, Bayer AG.

Articles

Continued process verification for a cleaning validation program begins once the validation study is complete. 

Continued Process Verification for Cleaning Validation– Challenges and Pitfalls

Genezen has opened its new process development and analytical lab for viral vector production.

Genezen Starts Up Operations at Lenti- and Retroviral Vector Process Development Lab

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

Different methods to calculate limits for impurities will give different answers. The prediction interval method may be ideal.

From PharmTech: Detecting and Determining Quantitation Limits for Impurities

Christopher Burgess, PhD, is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, UK.

Different methods give different answers when calculating limits for impurities. The prediction interval method may be the best option.

Detecting and Determining Quantitation Limits for Impurities

Raphael Bar, PhD, rbar@netvision.net.il, is a consultant at BR Consulting in Ness Ziona, Israel.

Part 1 of this article series demonstrates, using real-world process data, that the four fundamental assumptions underlying the classical Shewhart control charts—randomness, independence, constant average, and constant variation—are often not met.

Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 1. Conventional SPC Rules and Pharmaceutical Process Data

Ajay Pazhayattil*, M.Pharm, DBA, Ajay.Pazhayattil@capcium.com, is vice-president, Scientific and Regulatory Affairs at Capcium.

Sanjay Sharma is vice-president and head of technology transfer at Lupin Pharmaceuticals

Amol Galande is senior manager of the process development laboratory at Lupin Pharmaceuticals

Marzena Ingram is senior manager, quality and compliance at Eurofins CDMO. She led and hosted several cGMP audits, and has diverse quality assurance and technical operations experience. 

Robert Rhoades is managing partner at Validant.

A data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.

Assessing Legacy Drug Quality 

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

A holistic approach to validation and quality assurance is essential.

Prepping Fill/Finish Systems to Ensure Quality Output 

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: Part 1

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for solid oral dosage forms.

Enhancing Process Validation for Solid Oral Dosage Forms: Part 2

Regulatory, analytical, and process concerns must be taken into account.