CONTROLLED, CONNECTED, ACCURATE
ELECTRONIC BATCH RECORDS
GMP-based Electronic Batch Record systems support compliance with Good Manufacturing Practices and ensure better quality control overall. InstantGMP™ all-in-one software streamlines the process still further, from producing Master Manufacturing Formula records (or Master Batch Records) to Batch Production Records to overall workflow management.
With InstantGMP, one convenient system empowers designated staff at each production area with the ability to view or manage both Master and Batch Production Records in real-time using a common dashboard.
EASY TO CREATE, EASY TO FOLLOW
MASTER PRODUCTION RECORDS
A Master Manufacturing Formula (or Master Batch Record) is required by Good Manufacturing Practices for each unique formulation and each unique batch size you produce.
InstantGMP software makes producing Master Production Records that capture GMP requirements an easy to follow, straightforward process.
Convenient tabbed format provides easy access to all workflow steps
Interconnected Dynamic Fields can be created and configured at each step, making it easier to:
- Record data and connect it from previous steps to the current step
- Perform calculations with data from current and prior steps: formulas can be programmed to perform calculations and comparisons with all previously entered dynamic fields at any step in the batch record
- Provide dropdown selections for acknowledgment of operations
- Master Production authors can test the dynamic fields prior to approval, ensuring that once approved the dynamic field will function as needed in the batch production record
Scale up/down function allows for the creation of new master records when a change in yield of a product is required.
- This function automatically revises the bill of material amounts to reflect the yield change.
One-click versioning so—once approved—making changes to Master Production Records is simple and fast.
ONE-CLICK CONVENIENCE FOR
BATCH PRODUCTION RECORDS
Batch production records are exact copies of the master production record. With InstantGMP you can create a new batch production record with just one click. See example below.
The process ensures safety, identity, strength, quality and purity—all the GMP requirements—for each batch of product produced. You’ll get real-time, traceable management ability.
Each step under the manufacturing instructions provides all the needed information to complete that step.
Before production can begin, the batch record must be electronically signed and issued by a member of the quality team.
Material usage is automatically recorded at each individual step and updated in inventory, including the history of all materials used:
- Unique material receipt, batch and production numbers
- When a product is planned for production
- When a product was actually produced
- Quantities of raw materials and ingredients that went into a batch
- Which lots of raw materials and ingredients were used
- Actual manufacturing steps that were followed and the results obtained
- Any deviations that were investigated and resolved
- Electronic time-stamped signatures of performers, reviewers and quality
Prior to batch record production, picklists allow you to create bills of materials—especially useful in high volume production facilities where planning and staging are critical to maintaining efficient workflow.
STREAMLINE WORKFLOWS THROUGH
A SINGLE INTEGRATED SYSTEM
InstantGMP provides Electronic Master Manufacturing Formula/Master Batch Record workflows that enforce collections of information and data that contain all the information required by GMPs.
- Cover page summarizing details including name, strength and expected yield.
- Bill of materials, including weight or measure of each component to be used.
- Equipment to be used in the manufacturing process.
- Any attachments that should be referenced:
- Documents, pictures and videos are attachable at each step, so difficult processes are easy to understand and complete.
- A listing of in-process testing to be completed:
- Links to electronic logs for equipment and production areas make cleaning and use entries straightforward to complete and easy to verify.
- Step-by-step instructions, including materials, equipment and locations used in the production process:
- Each step is easily customizable for signature requirements and equipment or room use.