GAMP 5: Pragmatic Use for Regulatory Compliance

GAMP 5 brings a new look on the user / supplier relationships and on qualifications. Risk Analysis and especially Risk Management notions are emphasized. Reinforcing its presence as the reference in numerous standards and regulatory guidance’s in Health Industries as well in Europe as in America, this new GAMP 5 must be taking into account in the future validation and qualification strategies for computerized systems. Version 3 of PIC/S PI 011 guidance, ICH Q9, future version of GMP Annex 11, and ASTM E2500 are also to be taken into consideration because they are for a big part at the origin of GAMP 5 new requirements.

 Understand the GAMP, its historical context, its objectives, its recognition status by regulatory agencies.

 Know and understand relationships between GAMP 5 and others regulatory guidance’s and/or texts.

 Know the differences between GAMP 4 and GAMP 5 and their implications on validations.

 Know how to use GAMP 5, its technical organization, its content (methodologies and templates).

 Understand differences and common points with a traditional validation « V Cycle ».

 Know how to use GAMP 5 recommendations in a pragmatic manner.

 Know how to leverage GAMP 5 recommendations to be in regulatory compliance.

 Separate Commissioning/FAT/SAT from validation test and know how to integrate supplier tests into validation (Integrated Validation).

1. What is GAMP?

GAMP, what is it? Why has it been written and by whom? What are its objectives? How is it recognized today in the Health area, by industries, by suppliers, and by regulatory agencies? What is its scope? How is it organized?

2. GAMP founding principles

Understand why and how GAMP falls within the framework of a project life cycle. The founding principles of « V Cycle ».

3. Main differences between version 4 and version 5

GAMP 4 = 5 categories; GAMP 5 = 4 categories. The importance of designer and supplier tests. The differentiation between Qualification and Validation.

4. User role as defined in GAMP

User versus Regulated Company Definition of roles and responsibilities regarding computerized systems of User implied in a GAMP Validation approach. Which templates to use, from Validation Master Plan to Validation reports? Where to start a validation approach at a site, a division, a group level? How to go from the global approach to the different systems concerned? How to adapt the validation strategy to system, project, operational contexts. What are the tools available for an efficient operational maintenance (SLA, DRP, Change Control, Configuration Management, Periodic Validations …). Interactions of Users with Suppliers.

5. Supplier role as defined in GAMP

Definition of roles and responsibilities regarding computerized systems of Supplier implied in a GAMP Validation approach. Which templates to use, from Project Plan to Tests Data Sheets? How to rationalize documentation and effort about documentation? Project Management role. Interactions of Suppliers with Users

6. Summary of the sequencing and benefits from Validation

Parallel between Validation and Design. Compliance. Cost reduction. System knowledge.

PRACTICAL CASE STUDY

Several practical case studies are proposed all along the training session.

A Multiple Choices Questionnaire is proposed at the end of the training session in order to evaluate the acquired knowledge.