GMP REVIEW – What it is and why it is important to doit well

WHAT IS IT?

The term GMP Design Review indicates a formal, structured and multidisciplinary process of analysis of the conformity of the design to the GMP standards of reference, aimed at verifying its robustness in terms of protection and safeguarding of the Quality and Safety of the product, while at the same time highlighting any areas for improvement on which to direct the commitment and resources.

In combination with risk analysis techniques such as FMEA and FMECA, the GMP Review represents a useful support for the continuous improvement of the Quality of the Production process, as it allows to identify the different levels of risk, propose shared mitigation actions by calibrating the time and resources necessary according to the real business needs.

The GMP Design Review is easily applicable to:

• New and existing facilities
• New and existing systems/plants

WHY?

There are many regulatory references that refer to the execution of the GMP Review. In particular:

• EU GMP Eudralex Vol.4 Annex 15 “Qualification and Validation”:
• ICH Q7 “Good Manufacturing Practice for Active Pharmaceutical Ingredients”

Moreover, at a managerial and competitive level:

• The execution of the GMP Review supports the Design approval process in the case of new facilities and/or plants: its execution in the Conceptual Design phase makes it possible to identify any design weaknesses in the very early stages of engineering but also to evaluate the pros and cons of different design proposals, both from a GMP, and for the strictly “business” aspects.

• The execution of the GMP Review can be integrated in a Gap Analysis context in GMP remediation projects or related to the redevelopment of complex plants and systems.

GMP Review is also used to support refurbishing projects, often applying risk analysis techniques, in order to compare the GMP compliance of different project proposals.

• The GMP Design Review by its nature is proposed as a useful piece in the context of the Contamination Control Strategy activities, as an adequate design is undoubtedly the first and fundamental factor that contributes to ensuring the Quality and Safety of Pharmaceutical products and processes.

HOW?

The most common GMP Review design models are based on checklists developed from the GMP guidelines applicable to the type of plant/process being evaluated (example: CFR 210, CFR211, ICH Q7, Eudralex Vol. 4 Part 1, integrated with specific reference norms and standards).

Each point of the checklist is characterized by a combination of three elements, attributable to the GMP guidelines, which identify all the steps of pharmaceutical production and the elements of the “Pharmaceutical Quality System” that contribute to its correct performance:

• Keywords: these are the elements of the production process that contribute to ensuring the quality of products and processes, if adequately managed and controlled (examples: plant layout, plant layout, functional units such as warehouse, QC, Dispensing, Production, QA, etc.).
• Functions: these are the aspects that characterise the elements of the production process and that must be adequately managed and monitored to ensure the Quality and Safety of products and processes.
• Controls: these are the technical and procedural solutions recommended for a function to perform its task in the best possible way. The more efficient the controls, the higher the contribution to GMP quality.

If you have GMP Review needs, Primeco is happy to delve into all aspects of a good analysis and to support and guide you in all its phases.