InstantGMP™’s new software release features 115 updated SOPs.
CARY, N.C. August 10, 2021- InstantGMPTM, the leader in Good Manufacturing Practices software solutions, continues to advance the features of its groundbreaking InstantGMPTM PRO software. In the latest InstantGMPTM PRO software release, the innovative Document Management System includes 115 updated Standard Operating Procedure for a more straightforward and seamless SOP creation process.
As the basis of the FDA-required quality system for Good Manufacturing Practices, Standard Operating Procedures (SOPs) document the step-by-step operating instructions that facilities must follow for consistent and safe manufacturing of all regulated biopharma, dietary supplement, pharmaceutical and herbal products.
Although the FDA provides general rules and regulations as the guidelines for SOP creation, many manufacturers face difficulties adapting these general guidelines for their specific needs. To help mitigate these issues, facilities often rely on the use of templates to develop their SOPs. Unfortunately, most SOP templates are too generic and result in the creation of substandard SOPs.
To help manufacturers avoid the use of generic templates that do not clearly define the necessary instructions, roles and responsibilities, InstantGMP set out to create the ultimate SOP template solution. After carefully and deliberately interpreting the FDA regulations and guidelines, our GMP experts applied their findings to the SOP creation process. The result: 115 highly detailed SOPs that are relevant to the various operations of any GMP manufacturing facility.
“InstantGMP’s Full PRO Standard Operating Procedures set helps manufacturing facilities lay the foundation for an effective quality system” said Dr. Richard Soltero, President of InstantGMP. “Instead of relying on vague and generic templates, manufacturers now have access to fully realized SOPs that clearly and actively define the purpose, scope, and business requirements for each specific procedure, as well as identify all responsible parties and their respective action steps. It’s an efficient and cost-effective solution for established firms that need to update their SOPs and newly founded companies who are writing SOPs for the very first time.”
Designed to cover all of the aspects of the manufacturing facility, InstantGMP’s Full PRO Standard Operating Procedures set includes GMP Site Policies, General SOPs, Quality System SOPs, Material SOPs, Facility and Equipment SOPs, Computer System SOPs, Production SOPs, Labeling and Packaging SOPs, Safety SOPs and more. In order to stay compliant with all of the latest industry regulations and rules, these SOPs are updated with every new software release.
In addition to being included in the Data Management System feature of InstantGMPTM PRO software, select SOP sets are also available for purchase separately.
To learn more about how the InstantGMP’s Full PRO Standard Operating Procedures set can help your facility, contact us today!
About InstantGMP™, Inc.
Founded by pharmaceutical industry veteran Dr. Richard Soltero, InstantGMP, Inc., offers affordable all-in-one manufacturing and quality software. The company develops cloud-based electronic batch record software and standard operating procedures specific to industries that are required to follow FDA manufacturing regulations and Good Manufacturing Practices (“GMP”).
As a manufacturing software company, InstantGMP™ pioneered accessible, easy-to-use electronic batch record software for products manufactured using GMPs. The Company’s updated software simplifies the documentation and approval procedures for quality processes that keep all quality documentation organized in electronic format while providing for quality checks and workflow processes to make compliance with FDA requirements easy.