GMP Compliance
WHAT ARE GMP’S?
GOOD MANUFACTURING PRACTICES
You may be wondering, what is GMP and what is cGMP compliance? Current Good Manufacturing Practices or “cGMP” is essential for manufacturing any dietary supplement, medical device or drug product intended for human use. There are many interpretations of cGMPs, which can vary widely from country to country, but all compliance guidelines follow a few basic principles:
- Manufacturing facilities must maintain a clean and hygienic manufacturing area.
- Environmental conditions must be controlled in order to prevent the cross contamination of a dietary supplement, medical device or drug product from adulterants or contamination that may render the product unsafe for human consumption.
- Manufacturing processes must be clearly defined. All critical processes are validated to ensure consistency and compliance with specifications.
- Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the product are validated as necessary.
- The distribution of the dietary supplement, medical device or drug product minimizes any risk to their quality.
- Instructions and procedures are written in clear and unambiguous language.
- Operators are trained to carry out and document procedures.
- Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the dietary supplement, medical device or drug product are as expected. Deviations are investigated and documented.
- Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
- A system is available for recalling any batch from sale or supply.
- Causes of quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence.
GMP IMPACTS
EVERY PART OF YOUR OPERATION
One common misconception is that GMP only covers the process of manufacturing itself. But ensuring the safety and well-being of citizens in general, as well as quality of enforcement in particular, requires all aspects of the operation meet critical standards. If interrelated processes within GMP manufacturing were not controlled, that would affect the quality of output. Which is why:
GMP actually covers everything from the production process to complaint handling and all record keeping.
InstantGMP™ electronic batch record and electronic device history record software reinforcing Good Manufacturing Practices with workflows that implement the GMP requirements, and with master records and batch production records that ensure quality during production.
The GMP Compliance Process
An Overview
InstantGMP is the only all-in-one manufacturing quality and compliance solution with built-in compliant workflows. We can help your operation experience less downtime, fewer recalls and achieve full compliance with an affordable, integrated software package—just contact us for a personal consultation and demo.
For answers to more of your questions about compliance see the following:
A manufacturer chooses their vendors prior to receiving materials that will be used or made in the facility. InstantGMP has SOPs available that can guide the qualification of those vendors.
Once materials are ordered and delivered by a qualified vendor, they can be received into inventory.
- These materials, components, supplies, and other ingredients can be entered into the system—InstantGMP manages the receiving process and assigns unique numbers for each material, material receipts, and material lots; thus, setting up traceability.
- The FDA has requirements that encompass the purchasing, receiving, and testing of incoming materials; therefore, InstantGMP features multiple functions to keep them under control and organized.
- Additionally, a quality unit must sign off that the materials that were ordered are the ones that they have received. With our system, we manage the material types and statuses for you.
Before any materials and components can be used in production, they must have specifications.
- InstantGMP will manage and automatically track specification and version numbers in an effort to streamline the quality process.
Materials required for production must be sourced, purchased and received, ready for manufacturing to begin.
InstantGMP software can integrate purchase orders, receipts, split lots and all purchased materials tracking and receiving, as well as link to manufacturing bin records and production lots.
Materials must be quality checked prior to manufacture.
- InstantGMP requires sign off at each stage of manufacture, including receiving.
Electronic Batch Records describe and guide how the product will be produced.
- With InstantGMP, when it comes time to manufacture a product, a master batch record is written, then an electronic batch record is made from it, capturing all fields from the master and ensuring consistency for product production.
Storage and distribution of finished products are covered by FDA.
- InstantGMP™ records the use, storage and movement of finished products.
This diagram shows a typical process flow in a GMP manufacturing operation. After a manufacturer identifies the product that will be manufactured and what materials, components, and other supplies are required to start production, a standard process unfolds:
