GAMP 5 - The Aim

PharmOut are committed to helping companies strive towards regulatory compliance. We recommend that any new or remediation required for computerized system should comply with GAMP 5. Using the Functional Risk Assessment and other risk based techniques, you produce a lot less paperwork.

The use of ASTM E2500 or other risk assessment tools should halve the amount of paper, not a bad outcome in a world were validation is not seen as a value adding activity.

Want to know more?

Go to the ISPE website, www.ispe.org and order the GAMP 5 guide, "Using a risk based approach for Computerised System Validation", it is an excellent document.

If you would like to know more before you buy, read on.....

GAMP 4 has been reviewed, restructured and enhanced to give comprehensive guidance to professionals involved in manufacturing. GAMP 5 supports up to date, practical good quality practices as it concentrates more on science and ultimately the risk to the patients safety.

The main updates from GAMP 4:

Quality by Design is being emphasised in all aspects of production.
Uphold patient safety, product quality, and data integrity, while also delivering business efficiency.
Provides a flexible framework by which companies can demonstrate their systems are fit for intended use, rather than prescribing a methodology on how this should be achieved.
Assist suppliers to the life sciences industry by giving them guidance on the development and maintenance of systems by following good manufacturing practices.
Leveraging the expertise of the suppliers in the areas of testing and documentation to aid in verification of the product/process.
A more concise explanation of the current and future regulatory trends, with a stronger focus on life sciences, risk based approaches and the importance of good documentation.
A stronger focus on continuous improvement within the Quality Management System.
The ideas are further aligned with the ASTM E2500 Standard for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.
Seize opportunities to improve a process or system through periodic review, root-cause analysis and Corrective and Preventive Action (CAPA).

Still want to know more, follow this link to more about GAMP 5 Sections.

Acknowledgements to the ISPE