Good Manufacturing Practices require that you have a Master Batch Record or Master Manufacturing Formula for each unique formulation and each unique batch size. InstantGMP™ software makes producing master production records that capture GMP requirements an easy to follow straightforward process. The process steps for creating a master production record are located under the following tabs:
InstantGMP™ provides electronic master batch record workflows that enforce collections of information and data that contain all the information required by GMPs:
- A cover page that lists all information including name, strength and expected yield.
- A bill of materials including the weight or measure of each component to be used.
- Equipment to be used in the process.
- Any documents that are to be referenced in the master production record.
- A listing of in process testing to be completed.
- 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.
- Documents, pictures and videos are attachable at each step making difficult processes easy to understand and complete.
- Links to electronic logs for equipment and production areas making cleaning and use entries straightforward to complete and easily verified.
Once approved, master production records can be versioned up with one click making needed changes simple and quick. A scale up or down function allows for the creation of new master records when a change in yield of a product is required. The function automatically revises the bill of material amounts to reflect the yield change. By following the outlined process, the GMP requirements of safety, identity, strength, quality and purity can be ensured for each batch of product produced.