Comprehensive On-Site GMP Training for Pharmaceutical Manufacturer

December 20, 2019
by SeerPharma

SeerPharma’s training division grows from strength to strength with several companies requesting tailored on-site QA/GMP training for staff. Recently a major multinational pharmaceutical manufacturer approached SeerPharma to address the following key areas of interest for staff at their firm:

  • Global regulations
  • Good report writing
  • Key quality assurance system requirements (including auditing)
  • Good Laboratory Practice
  • Process validation/design of experiment requirements
  • Analytical method validation requirements
  • Biological assay validation & control requirements
  • Data Integrity

In response SeerPharma tailored a 4-day training package for the firm addressing these needs, and customising our content to work with the client's existing business practices.

GMP blocks

Day 1

The Regulated Environment (2 hours)

  • List the major GMP regulatory bodies worldwide (briefly)
  • State the difference between Regulations, Guides & Codes (briefly)
  • Assess the current status of International MRAs and MOUs (briefly)
  • Describe how governments regulate products and manufacturers in relation to the client's business
  • State the essential requirements for GMP compliance in relation to the client's business

Good Report Writing (1.5 hours)

  • Good writing practices and translating this into effective report writing
  • Why effective report writing is important

Key Quality Assurance System Requirements (3.5 hours)

  • What is a Pharmaceutical Quality System?
  • Quality Risk Management
  • Key Quality System Elements for Continuous Improvement
    • Failure Investigation and Deviation Management
    • Change Control
    • Product Quality Reviews (PQRs)
    • The importance of auditing (internal and suppliers)

Day 2

Good Laboratory Practice requirements (3 hours)

  • The key elements and basic principles that make up GLPs and GMP in a testing laboratory and production environment
  • The importance of records, raw data, traceability and documents to Quality Systems
  • Your role and responsibilities regarding GLP and GMP compliance

Process Validation/Design of Experiment requirements (4 hours)

  • Requirements for demonstrating that specific products and processes consistently meet predetermined specifications
  • The current approach of PIC/S GMP Annex 15
  • The life-cycle approach
  • A roadmap for process validation
  • Tools and templates for process validation
  • Design of Experiments (DoE)

Day 3

Analytical Method Validation requirements (4 hours)

  • Performance parameters required for analytical method validation
  • Acceptance criteria for analytical method performance parameters
  • Requirements for inter-laboratory method transfer
  • Calculating the capability of a test method

Biological Assay Validation & Control requirements (3 hours)

  • Identify biological assay method validation criteria
  • Prepare a validation plan for a microbial limits test method
  • Viral applications

Day 4 (half day)

Data Integrity (3.5 hours)

  • Integration of DI into your QMS using a risk-based approach
  • Protection and security of raw data and original records
  • Control of your data when utilising vendor third parties
  • Developing practical audit and remediation strategies for DI

With a bank of content that has been developed and over 30 years, SeerPharma is well-placed
to tailor and deliver QA/GMP training sessions to your staff on-site.

For more information on our most commonly requested courses to run on-site, please

Contact us to learn how we might be able to assist with your internal training needs.


Filed Under: gmp training