Industries: Pharma / Biotech

Specifications for APIs & Pharmaceutical Drug Products

Active Pharmaceutical Ingredient (API) & Drug Product Specifications - From Clinical Development to Market Approval

Course Director: TBD

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance) 

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

This active pharmaceutical ingredient (API) product compliance course will help the attendee to establish specifications meeting global regulatory requirements and expectations. Participants will also become effective in justification of specifications.

Why This Course Matters

Specifications for active pharmaceutical ingredients (APIs) and pharmaceutical drug products, both chemical drugs and biologics, are essential for product quality and patient protection. The goals of specification setting are (1) to determine appropriate and safe limits or quantitative ranges during clinical development and (2) to justify specifications for the product to enter the market. One of the most difficult challenges in establishing and subsequently justifying specifications is achieving the appropriate balance among all factors – patient safety and efficacy, scientific data, analytical variability, process knowledge and capability, regulatory requirements, and business issues.

The approach to specification setting and their justification has undergone significant change. Strategic international ICH regulatory guidances have been adopted that are driving the entire pharmaceutical industry, including both chemical drugs and biologics, to a higher standard of performance, including Quality by Design (QbD), Quality Risk Management (QRM) and Pharmaceutical Quality System (PQS).

Therefore, it is most important for a pharmaceutical company to have an effective and regulatory compliant approach to setting specifications that can meet both FDA and EMA requirements and expectations. At each stage of drug development, from Phase 1 through commercialization, the basic question needs to be addressed: ‘What is absolutely necessary for the assigned specification to be successful in getting the chemical drug/biologic through clinical trials and into the market, but without impacting patient safety or creating delays in the program?' Of equal importance is the need to justify which quality attributes do not need an assigned specification. Regulatory compliant deficiencies in assigned specifications have resulted in clinical holds and market approval delays.

Who Should Attend

This medical product compliance course is designed for those engaged in R&D, Regulatory Affairs, Quality Assurance and Quality Control who are responsible for activities in the development and manufacture of Active Pharmaceutical Ingredient (API) and Drug Products. Personnel who desire an in-depth knowledge of the critical role of specifications and the importance of USP compendial requirements, FDA regulations and ICH guidelines, as well as the relationship between ICH Guidelines and the Common Technical Document (CTD) will find this course of great value.

This comprehensive three-day course is also beneficial to R&D personnel responsible for the use of specifications in conducting Quality by Design (QbD) development of both API and Drug Products.

The course is also of interest to personnel in all departments who participate in the support of manufacture and release of APIs and Drug Products. This includes development personnel in preparing API and Drug Product under cGMP protocols for clinical and non-clinical use, as well as analytical chemists involved with stability testing, assays, methods development and drug release.

First Day


  • To ensure that attendees have a clear understanding of USA and international requirements and expectations (CFR; FDA; EMA; ICH; USP, PhEur), and the background necessary, to effectively establish, justify and defend global active pharmaceutical ingredient (API) and drug product (DP) specifications
  • Scope
    • Product Specifications Are Necessary
    • Phase-Appropriate Specification Assignment
    • Quality by Design (QbD) – Applying Science to Spec Setting
    • Pharmaceutical Properties to Measure
    • Approaches to Establishing To-Be-Marketed Specifications
    • Defending Specifications to Regulatory Authorities

Section 1: Product Specifications Are Necessary

  • Specifications vs. Action Limits
    • Specification definition
    • The 3 Components of Specifications
  • Release Specifications vs. Shelf Life Specifications
    • Differences between Release and Shelf Life Specifications
  • Periodic Skip Testing
  • Real Time Release Testing (RTRT)
  • Regulatory Specification Requirements
  • Marketed Product Regulatory Specification Requirements
  • Marketed Product Regulatory Specifications ‘Recommendations’

Section 2: Phase-Appropriate Specification Assignment

  • Phase-Appropriate Specification Assignment
    • FDA/EMA Acceptance of a Risk-Based Approach
    • Phase-Appropriate Specification Strategy
    • Phase-Appropriate Spec Strategy: U.S. FDA
    • Phase-Appropriate Spec Strategy: EMA
    • Pharmaceutical Industry Practice

Section 3: Quality by Design (QbD) – Applying Science to Spec Setting 

  • From Clinical Development to Market Approval
    • Strategic Approach to setting Limits (Q8, Q9, Q10)
  • Elements of Quality by Design (QbD)
    • 5 Steps of QbD
  • Quality Target Production Profile (QTPP)
  • Critical Quality Attributes (CQA)
  • Critical Process Parameters (CPP)
  • Implementation of QbD Elements in Manufacturing CPP’s
  • Design Space (DS)
    • Challenges for Biopharmaceuticals
  • Control Strategy
    •  Elements of Complete Control Strategy (Q11 & Q 8)
  • Continual Improvement
  • Specification Committees
  • Out-of-Specification (OOS)
    • Principles of OOS Investigations
    • OOS Investigation and the Agency

Second Day

Section 4: Pharmaceutical Properties to Measure

  • Pharmaceutical Prosperities to Measure
    • Description / Appearance
    • Identification / Identity
    • Strength
    • Impurities / Purity
  • Specification
    • Suitable for Use
    • Scientifically Sound and Appropriate Test Method
    • Relevant Output
    • Right Testing Location

Section 5: Approaches to Establishing To-Be-Marketed Specifications

  • Understanding Basic Statistics
    • Significant Figures and Rounding
    • Mean and Standard Deviation
    • Tolerance Interval
    • Process Capability Rate
  • Establishing Specifications
    • Specification Absolute Limit to Patient Safety
    • Specification Limit Based on Patient Safety Target
    • Specification Range Based on Manufacturing Capability
    • Specification Limit Based on Manufacturing Capability

Section 6: Defending Specifications to Regulatory Authorities

  • Purpose of a Specification vs. Defending a Proposed Specification
  • Justification of Specifications
  • FDA / EMA Clear and Justified Specifications
  • Specification Life Cycle
    • Market Approved Specifications
    • Annual Specification Review
    • Changing the Specification Due to Manufacturing Changes
    • Completion of Specification Post-Marketing Commitments

Section 7: Basics of Analytical Method Validation

  • Introduction
  • Analytical Method Validation
    • Non-compendial Analytical Procedures
    • Validation Characteristics
      • Accuracy
      • Precision (Repeatability)
      • Specificity
      • Detection Limit
      • Quantitation Limit
      • Linearity
      • Range
      • Robustness
      • Stability of Solutions

Learning Objectives

At the end of the two-day course attendees will:

  • Gain a solid understanding of the regulatory compliance requirements and expectations (FDA, EMA, ICH) for API and drug product specifications, for both chemical drugs and biologics
  • Have the tools and understanding to establish regulatory compliant specifications that are clinical phase-appropriate, incorporating Quality Risk Management (QRM)
  • Understand the ICH Q8, Q9 and Q10 Quality by Design (QbD) approach applied to setting specifications as part of an effective control system
  • Be able to appropriately package specifications and their justification into Module 2.3 and Module 3 of the Common Technical Document (CTD)
  • Learn how to avoid major delays in clinical development or market approval due to ineffective setting of specifications


"This course a very good and its focus was on target. The material was delivered in a straight forward manner and easy to understand." Tom N., Principal Analytical Chemist, Mallinckrodt
"The course was laid out very well. For a topic that could have been a little boring, the instructor did an excellent job of keeping the class engaged. Well presented, I would definitely take classes with this instructor again!" Christina N., Specification Associate, Johnson & Johnson
"This course was presented in an interactive manner with adequate real life dos and don'ts examples." Lara, Director of Regulatory Affairs, Nexgen Pharma
"The Course Director shared real-world examples of projects that worked on the industry. This is a great improvement on many other courses. Too often, course work details regulations and theoretical concepts. This course, however, correctly balanced case studies and regulations within the pharmaceutical industry. The instructor had a great amount of experience in several different dosage forms and in several disciplines within the industry." Ted R., Supervisor, BI Roxane Inc.
"The Course Director is very knowledgeable about the subject matter and presented it in a very interesting way. Use of course materials and real life examples were very helpful in explaining the concepts and ideas. The casual and interactive nature of the course was great for getting any questions answered and for encouraging the flow of dialogue and information." Jennifer B., AT Supervisor
"The course was taught phenomenally. Best API training course I have taken. I would highly recommend this to a friend." Susasha D., RA Associate, Teva/Barr
"This course is very informative and the Course Director is very experienced and knowledgeable. I would highly recommend this course to anyone involved with specifications." Syed R., Manager (PD), Incyte Corporation
"This course is very informative. I will be using everything that I learned here for my work, and I learned a lot! Thank you." Natalya S., Associate Director-RA CMC, Daiichi-Sankyo