Specifications for Small Molecule Drug Products
Specifications for Small Molecule Drug Products

Course Description

The specifications applied to drug products and raw materials used in the production of medicines are important elements in safeguarding patient safety and ensuring drug product efficacy. Regulators will expect to see proposed specifications in a drug product marketing application that control important quality attributes within suitable limits. The purpose of this course is to help applicants to decide which attributes to control in written specifications and how to approach setting appropriate values for each parameter, both at release and over the shelf life of the product. Topics include current regulatory guidance, including upcoming changes, using risk assessments to control attributes such as residual solvents and elemental impurities, specifications for selected novel dosage forms, justifying new impurities in generic drug products, and the control of genotoxic impurities. An important element to consider in the control of pharmaceutical materials is the suitability of the test methods used for each quality attribute. Recent USP and ICH guidance suggests that regulators will focus on this area in the coming years, and this important topic is covered in the course. Each day will include a workshop that will reinforce the learning points.

Regulatory guidance:

  • Specifications (ICH Q6A)
  • Impurities (ICH Q3 family of guidance documents)
  • Genotoxic impurities (ICH M7)

  • Risk assessments for residual solvents, elemental impurities and extractables
  • Excipient specifications
  • Control of drug substance vs. drug product
  • In-process specifications and parametric release
  • Release vs. shelf life specifications

Specifications for specific dosage form types:

  • Oral liquids/solids
  • Parenteral drug products
  • Topical drug products
  • Inhalation drug products
  • Liposomes

  • Justifying new impurities in generic drug products
  • Test method suitability
  • A risk-based approach to the control of genotoxic impurities
  • Current regulatory expectations
  • How to set meaningful specifications for raw materials and drug products
  • Using the principles of quality risk management for impurity control
  • Avoiding common errors and omissions

Specifications for Small Molecule Drug Products

New Dates TBA, Live Online Training
Regular price €1.850,00
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per 
Dr Mark Powell

Dr Mark Powell a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016.

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  • 09:00 AM Vienna time
  • 08:00 AM London time
  • 04:00 AM New York time
  • 01:00 AM Los Angeles time

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Course Description

The specifications applied to drug products and raw materials used in the production of medicines are important elements in safeguarding patient safety and ensuring drug product efficacy. Regulators will expect to see proposed specifications in a drug product marketing application that control important quality attributes within suitable limits. The purpose of this course is to help applicants to decide which attributes to control in written specifications and how to approach setting appropriate values for each parameter, both at release and over the shelf life of the product. Topics include current regulatory guidance, including upcoming changes, using risk assessments to control attributes such as residual solvents and elemental impurities, specifications for selected novel dosage forms, justifying new impurities in generic drug products, and the control of genotoxic impurities. An important element to consider in the control of pharmaceutical materials is the suitability of the test methods used for each quality attribute. Recent USP and ICH guidance suggests that regulators will focus on this area in the coming years, and this important topic is covered in the course. Each day will include a workshop that will reinforce the learning points.

Regulatory guidance:

  • Specifications (ICH Q6A)
  • Impurities (ICH Q3 family of guidance documents)
  • Genotoxic impurities (ICH M7)

  • Risk assessments for residual solvents, elemental impurities and extractables
  • Excipient specifications
  • Control of drug substance vs. drug product
  • In-process specifications and parametric release
  • Release vs. shelf life specifications

Specifications for specific dosage form types:

  • Oral liquids/solids
  • Parenteral drug products
  • Topical drug products
  • Inhalation drug products
  • Liposomes

  • Justifying new impurities in generic drug products
  • Test method suitability
  • A risk-based approach to the control of genotoxic impurities
  • Current regulatory expectations
  • How to set meaningful specifications for raw materials and drug products
  • Using the principles of quality risk management for impurity control
  • Avoiding common errors and omissions

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Specifications for Small Molecule Drug Products

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