InstantGMP and GAMP 5 Validation Standards: Improving FDA regulated products

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InstantGMP and GAMP 5 Validation Standards: Improving FDA regulated products

The InstantGMP Manufacturing Execution System software solutions were initially developed for in-house use in response to the challenge of significantly improving the way FDA regulated products are developed and manufactured. The proven InstantGMP methodologies are made commercially available as Real-Time web based ‘Cloud’ applications that provide immediate ‘Fast Track’ solutions for initiating and maintaining compliance with GMP (Good Manufacturing Practices) guidelines which govern the development and manufacture of all FDA regulated drugs, dietary supplements and medical devices (with the exception of software embedded within medical devices).

The primary purpose of GAMP 5 (Good Automated Manufacturing Practices), which is used for InstantGMP validation, is to provide a cost effective framework of good practices to ensure that computerized systems are fit for intended use and compliant with applicable regulations.

InstantGMP developed and maintains MES (Manufacturing Execution System) systems as web based data entry applications and databases which monitor, report and archive the GMP manufacture of any FDA regulated product while managing risk to patient safety, product quality and data integrity in the spirit of GAMP 5.

The computerized system life cycle described in GAMP 5 for a regulated company should not be confused with the need for a defined approach or method for software development, which is typically the responsibility of the software supplier. InstantGMP’s position, as a supplier of software to be integrated into the regulated manufacturer’s process, is to maintain InstantGMP products in keeping with GAMP 5 guidelines.

The primary business benefit to a manufacturer of FDA regulated products upon implementing an existing, proven, commercial InstantGMP software solution will be the immediate roll out of a system that is documented as being fit for the intended use and can make manufacturing compliance easy.

Users of InstantGMP software will in practice inherit software compliance to regulator guidelines like GMPs and will henceforth retain compliance via a continuous improvement life cycle provided by InstantGMP as documented in SDLC (Software Development Life Cycle) policy.

Using InstantGMP allows an easy and direct transition from paper batch records to automated electronic batch records that are acceptable to the FDA. All auditable forms are included, namely; MPR (Master Production Recrods), BPRs (Batch Production Records), SOPs (Standard Operating Procedures), Inventories, Traceability Matrix and Audit Logs.

Users are provided with a computerized method of strategically reducing risks to patient safety, product quality and data integrity by automatically enforcing compliance with regulating authorities’ guidelines. Establishing and maintaining a Risk Level Prioritization Scheme benefits the regulated user by allowing the demonstration of responsible Risk Management to regulating authorities.