Drug Substance and Drug Product Manufacturers See Value in Paperless Manufacturing
Richard Soltero, Ph.D.
PharmaDirections, Inc.
We recently completed a survey of small to mid size chemical and pharmaceutical manufacturers who could take advantage of InstantGMP™ to increase their client base and their business. The survey was answered by a cross section of participants involved in manufacturing active ingredients, intermediates and finished products. We have compiled the results and thought you might be interested inthe comments.
Feedback from Survey
- An interactive web-based paperless manufacturing system that allows clients to view project status, inventory levels and manufacturing information on-line will help bring in more clients and business
- Firms interested in risk management typically like to see this type of information for day to day planning. Clients often request up-to-date accrual information on various projects at various stages of development
- Having a real-time update capability will greatly add value to client communications and project management.
- A web-based electronic batch record system that allows a business to track batches and inventory in real-time with web access will be helpful for attracting more business. It can give a client a better sense of comfort/control with their project since they are not just relying on the service provider for answers.
- Access to real-time data from anywhere will allow your business operations to run more efficiently. Reports and information gathering is time consuming and requires some type of quality review. More access = more communications = more trust = more business.
- A virtual manufacturing application where the quality system requirements are built into a cloud application thus making it mandatory for users to follow the SOPs will provide better quality of information in a timely manner. It will ensure SOP requirements are followed.
InstantGMP as a Solution for GMP Compliance
Instant GMP™ is a web-based Part 11 compliant manufacturing execution system. It was built on a Quality by Design approach to paperless manufacturing that utilizes a quality system that is integrated into an internet based data base application that operates like a full scale MRP or ERP, but is specific for drug substance or drug product manufacturing. It covers all of the production process starting at setting raw material specifications to ending at manufacturing with electronic batch records. It allows significant reductions in documentation cycles and quality approval times compared to traditional paper-based systems. The big picture is always available, but it can zoom into any part of the operation.
Because it has hard coded standard operating procedures built into the software it can prevent errors and maximize quality. It can be accessed remotely from any location and has security settings on each screen that let it be viewed by anyone while maintaining full data protection. An international pharmaceutical manufacturer with InstantGMP would allow their importer to be constantly in touch, to be able to view their progress on-line and to be assured that GMP compliance is automatic.
PharmaDirections owns and out-licenses this software system. PharmaDirections has been using InstantGMP to manufacture clinical trial materials and regulated products for their clients since 2004.
About PharmaDirections
PharmaDirections offers the highest level of scientific and management expertise to transform new technologies into successful drug products. They are a consulting and project management company with a unique approach to managing preclinical, CMC and regulatory affairs programs. They provide strategic planning then oversee and direct the pharmaceutical contract research using their own scientific experts and project managers at partner laboratories who are our sub-contractors. PharmaDirections is a comprehensive R&D resource for pharmaceutical and biotech companies who need more than just outsourcing of their API or drug product development and manufacturing.