Before starting the implementation, you should confirm the processes that will be changed for the InstantGMP software. You can write up a plan and request a review with your InstantGMP trainer to ensure the necessary information will be entered correctly the first time. The training materials and videos can be used to show some examples of how other companies in your industry may have implemented this software.
Training, experimenting, testing and documentation are the cornerstones of Good Manufacturing Practices.
However, mistakes and oversights can occur during their processes. When that happens, the results can negatively affect the manufacturer’s database resulting in compromised products, invalid documentation, regulatory fines and other concerns.
Being Good Manufacturing Practices (GMP) certified is vital for any manufacturing facility’s success. This certification identifies manufacturers who are fully compliant with all FDA regulations and have the necessary systems in place to produce pharmaceuticals and dietary supplements using proper quality standards and control.
Upon its arrival, InstantGMP™ PRO revolutionized the industry by eliminating the reliance on purchasing several pieces of expensive software to perform all the necessary processes that support Good Manufacturing Practices. With this all-in-one GMP solution, manufacturers, developers, formulation groups, and researchers could now ensure compliance and accuracy, store and secure all documents, maintain an accurate inventory, train team members, and perform all necessary GMP processes without having to navigate a sea of stand-alone software.
InstantGMP™’s barcode scanning feature has many applications that will benefit any manufacturing environment:
- Generate User ID badges with barcodes
- Sign electronically with a barcode scanner
- Accept requisitioned Materials
- Add Materials to inventory
- Create Material status labels
- Update Material statuses
- Record inventory use
- Approve Master Production Records, Device Master Records, Device History Records, and Batch Production Records
- Integrate equipment to streamline inventory weight capture during production
- Change bin locations
- Split materials into different lots
The switch from paper-based systems to electronic systems was a major advancement for the manufacturing, packaging, distribution and wholesale industries. Gone were the days of physically writing and storing the various documents associated with Good Manufacturing Practices.
As the foundation for good manufacturing practices, a Master Production Record (MPR) defines the necessary steps manufacturers must take to produce everything from pharmaceuticals to dietary supplements. It’s the manufacturing process equivalent of an instruction manual for assembling a piece of office furniture, a recipe for baking a cake, or the directions for a road trip.
The InstantGMP Master Production Record (MPR) platform is designed for easy configuration
- The MPR platform efficiently builds product MRPs by using copy capabilities from a template, to create standard products and variations on those standards
- Product MPRs are connectable, e.g., a completed bulk formulation can be an ingredient in a packaging MPR.
- A product line changes over time; the InstantGMP MPR platform can accelerate the creation of new/revised product MPRs, selecting applicable elements from legacy formulas, instructions. etc. in other MPRs. This includes scalability for new/revised batch sizes.
- New business sometimes requires test batches; InstantGMP has designed a Make to Order (MTO) EBR to create them, without the need to use MPR logic upfront; then uses easy conversion to MPR operation when the new product is approved.
Document management systems (DMS) need repositories for both controlled and uncontrolled documentation. Any company that is required to comply with GMP (“Good Manufacturing Practice” quality guidelines and regulations) must have a comprehensive document management system in place which covers controlled and uncontrolled documentation.
Master Production Records (MPR) give the planning department a starting point for determining the materials required for inventory, while Batch Production Records (BPR) consume the inventory during manufacturing. Cutting-edge businesses often store these documents in an Electronic Documentation Management System (EDMS).
One of the cornerstones of an inventory management system is documentation, such as shipping manifests. Especially in the highly regulated cannabis, pharmaceutical, and biologics industries, generating accurate shipping manifests ensures robust inventory control.
Many companies still use paper-based systems and spreadsheets for their manufacturing documentation despite having numerous solutions available to them. This is in part because companies are concerned about:
- Process disruption
- Internal organizational issues
- Quality system change
The COVID crisis has done many things, but in particular, it has showcased the vastness and complexity of modern supply chain management. The branches of the modern supply chain extend far and wide, from manufacturing to distribution to allocation of a vaccine.
Too many virtual biotech companies are working with disjoined systems trying to manage a variety of contractors and vendors. While doing so, they are working to continually fund their manufacturing and clinical activities. To be successful in these efforts, a quality management system, such as InstantQMS™, that is attuned to the specific needs of an organization leveraging an outsourcing model allows virtual biotech companies to secure investor confidence, streamline workflows, and more easily achieve compliance.
Many customers come to InstantGMP because we provide an efficient way for them to become GMP compliant. After this is accomplished, they want to know how they can become GMP certified. Our partners at the GMP Compliance Resource Center can provide a thorough answer. In the main, the process is described in this article.
The FDA holds virtual biotech companies accountable for the clinical trials they sponsor. If a problem is to arise during a clinical trial, those who use a quality management system are more easily able to provide the necessary records to the FDA, because documentation is virtually processed in the system. A quality management system allows virtual biotech companies to remain accountable throughout the oversight of clinical trial development. Essentially, implementing a quality management system reduces risk and helps achieve compliance, all the while streamlining operations and increasing efficiency.
What is an SOP?
- Per ICH(International Council on Harmonization), an SOP is a detailed, written instruction to achieve uniformity of the performance of a specific function. They are informed by the guidelines of regulators (FDA, CDPH, etc.) as pertains to the organization and personnel, facilities, equipment and controls
To succeed today businesses must quickly onboard and train new employees, and simultaneously, keep current employees up-to-date with ever evolving procedures and protocols. As the world of work continues to evolve at record speed, the value of investing in employee training has never been clearer. Companies across industries have faced unprecedented challenges in recent months—financial uncertainties, new safety concerns, logistical and operational red tape—and those whose employees are agile, innovative, and forward-thinking are the ones that are coming out the other side. With such shifts coming nearly every day, however, employees need to be armed with the latest knowledge to help them not just stay productive and support the company’s bottom line, but to do so safely and compliantly. That’s where innovative workplace training comes in.
Master Production Records, also known as Master Manufacturing Formulas, are general manufacturing instructions. Each unique formulation and batch size must have its own MPR and should include:
- Identification of product name.
- Bill of Materials detailing the Weight, measure or count of each component needed to manufacture the batch.
- Equipment list.
- Component list.
- Statement of theoretical yield at each step in the manufacturing process.
- Expected yield of the finished product.
- Specific instructions for each state in the manufacturing process.
- Sampling and testing procedures.
- Instructions for manual operations.
The Software Development Life Cycle (SDLC) basic steps used by InstantGMP are:
Planning: User Requirements Specification (URS).
Analysis: Functional Specifications (FS).
Design: Detailed Design Specification (DDS).
Development: Coding and Unit Testing (UT).
Testing: Factory Acceptance Testing (FAT).
When the FAT is completed, the software is released for Validation which consists of Operational Qualification (OQ) and Performance Qualification (PQ).