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GAMP5 Compliance of Pharma Software

GAMP5 compliance of Pharma software that is either fully or partially automated is essential. The International Society for Pharmaceutical Engineering (ISPE) established a certain set of guidelines for manufacturers called Good Automated Manufacturing Practice (GAMP) in the year 1991. Since then, ISPE has come up with many versions and the current version is called GAMP5. According to GAMP5, Pharma software is required to follow a certain set of principles and procedures that ensure that the software is of good quality. GAMP5 usually covers the guidelines for development period as well as operational period of the project or software product. In other terms, the full life cycle of the product will be under the strict vigilance and required to adhere to the given guidelines.

Why GAMP5?

Many pharmaceutical companies follow GAMP5 guidelines while validating their systems as it helps them in

1. Understanding that the system has documented proof and that it is appropriate for their use before going live.

2. Avoiding defects in the system that is supplied to make sure that quality products are produced.

3. Bringing coordination between the user company and the seller company as they work together during the validation process to understand their roles and responsibilities.

4. Simplifying the regulatory requirements by interpreting them in simple and clear terms.

5. Avoiding the creation of duplicates.

6. Introducing and using common language and terminology for proper understanding and execution of work.

Categories in GAMP5

Since 1991, there have been 5 categories in GAMP. These categories kept evolving to accommodate changes in the system of pharmaceutical companies.

a) Category 1 deals with infrastructure software

b) Category 2 deals with firmware

c) Category 3 deals with Non-configured products

d) Category 4 deals with configured products

e) Category 5 deals with custom applications

GAMP5 Compliance with Caliber Products

Caliber Products meet the compliance standards set by ISPE effortlessly. The Caliber products are considered as “Configured off the shell” within the context of GAMP. It is expected that these systems have already undergone significant validation process during development by the vendor. Configured off the shelf systems requires less validation effort than customized systems. Therefore, it would be convenient to go with Caliber products in case you want to meet all the GAMP compliance rules and regulations without any hassles.