GMP Training

Good Manufacturing Practices (GMPs) are a cornerstone of pharmaceutical production. Annual GMP training is an FDA expectation whether your company is a large pharmaceutical company or CMO with hands-on manufacturing, or a small, virtual company. Sponsor companies are responsible for the safety, purity and integrity of their pharmaceutical product regardless of where that product is manufactured.

This course can be customized to meet your company’s specific needs. You can select from our listed topics or if there are specific concerns at your organization, we can incorporate topics that are relevant to your team.

Based on the number of topics chosen, the courses can be anywhere from 2 hours to multiple days. The training can be customized for various functional groups such as production, R&D, laboratory personnel, QA/QC, Senior and middle management, etc.

The training will include recent examples of FDA Warning Letters and 483s, as appropriate.

SUGGESTED GMP TOPICS

• An introduction to the new drug development process
• A short history of FDA and US drug regulations
• The role of FDA and regulatory sanctions
• Quality Assurance (QA) and Quality Control (QC) responsibilities
• The purpose and structure of the GMPs
• SOPs: authoring, reviewing, approving, and compliance
• Stability and expiration/re-test dating (FDA/ICH)
• Warehousing (receiving and distribution)
• Essentials of equipment qualification (IQ/OQ/PQ) and preventive maintenance
• Packaging and labeling controls
• Contamination control (with a focus on air handling, PPE, pest control, and equipment cleaning)
• Good documentation practices, including correcting GMP documentation
• Good Distribution Practices
• Change control
• Reserve samples
• Contractor qualification and Quality Agreements
• CAPA (corrective action/preventive action) initiatives
• Good laboratory practices including investigating out-of-specification results (OOS)
• Essential Part 11 compliance
• FDA vs. EU GMPs: Important differences