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Q7A: GMPs for Active Pharmaceutical Ingredients (T30)

Level: Intermediate
ISPE CEUs: 1.3
Type: Classroom Training Course

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Date

Location

Country

Instructor(s)

3 - 4 Nov 2016 Tampa, FL USA Jack C. Chu, PE

Description

Due to the growing pressures from global competitors, high marketing demands, and the requirements of GMP compliance, the bio-pharm industry (brand drugs and generic drug companies) are looking beyond the usual group of closely-knit suppliers. India and China engage in bulk actives and have been generating new dimensional API products with more specialized capabilities than those required by traditional drug products. In order to remain competitive, API manufacturers will need to attune themselves to this evolving dynamic global market.

This course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common deficiencies and problem areas related to the ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients Q7 and the USFDA's interpretation of ICH Q7, as defined in Q7A, the Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

The course also discusses the manufacturing equipment system and engineering practice and compliance issues. Participants will learn key regulatory information and practical utilization techniques to develop the ability to ask the right questions based upon science and the regulations knowing the relationship between this quality guidance for the production of APIs, and GMP regulations applicable to the production of pharmaceutical and biologic finished drug products.

Note: We recommend participants have a basic understanding of the GMP regulations and API manufacturing operations

Course Topics

  • Introduction to API GMPs and ICH Q7A for pharma and biologic products
  • Quality Risk Management, and Quality System Inspection Techniques
  • GMP Documentation and Change Controls
  • Facilities and Utility System Design and Maintenance
  • Processing and Process Equipment, and Production In-process Controls
  • Commissioning, Qualification and Validation for manufacturing systems and process systems

Course Modules

  • Reminders about APIs
  • A Quick History of API GMP
  • Quality Management
  • Impact and Risk Assessment
  • Personnel
  • Buildings and Facilities
  • Process Equipment
  • Cell Culture and Fermentation Specifications
  • Physical Processing and Packaging
  • Manufacturing Controls
  • Qualification/Verification and Validation
  • General Considerations Regarding Organization, Documentation and Production
  • APIs for Use in Clinical Trials

Take Back Your Job

  • Know the fundamental elements of API manufacturing, the GMP requirements and expectations of ICH Q7 and USFDA Q7A for quality management, GEP (good engineering practice) and the QRMS (quality risk management system).
  • Identify similarities and differences for the production and control of bulk active pharmaceutical ingredients from the current good manufacturing practices (cGMP) for the production and control of drug products; establish CPP (critical process parameters) to ensure the CQA (critical quality attributes) of API materials in the drug or biologic drug product manufacturing stream.
  • Understand the USFDA QSIT (Quality System Inspection Technique) expectations and viewpoints of regulatory authorities using quality and scientifically sound systems and their interactions to ensure systems are designed, utilized, and documented to the level expected by regulatory authorities.
  • Assess common issues of manufacturing systems and equipment and EMU (engineering, maintenance and utility) operational deviations, and develop corrective action concepts for manufacturing systems, process controls, and standard operating procedures that can prevent potential errors for the production of APIs

Attendance Recommended For

Professionals in quality assurance, quality control, DS (drug substance) development and manufacturing, plant management and production managers/supervisors, maintenance/utility engineers for facility/utility systems and production systems. Design engineers for manufacturing equipment and control systems, design/installation/CQV and regulatory inspectors related to the production of API.

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE Active Pharmaceutical Ingredients Community of Practice (COP).

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses.  CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.  Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials.  Statements of credit will be available for download in your ISPE account within four weeks of the completion of training.  Instruction for download will be sent when the CEUs are available.  One hour of education programming equals 0.1 ISPE CEU credits.

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