January 25, 2016

Compliance

You’re probably 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.

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.
  • 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.
  • The distribution of the dietary supplement, medical device or drug product minimizes any risk to their quality.
  • 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.

One common misconception is that GMP only covers the process of manufacturing itself. In actuality, GMP covers everything from the production process to other aspects such as how complaints are handled and record keeping.  The reason for this is the fact that the quality of enforcement and ensuring the safety and well-being of citizens in general is something that must be considered from all angles. Essentially, most if not all the processes within GMP manufacturing are interrelated and will affect the quality of its output.

InstantGMP electronic batch record and electronic device history record software reinforces Good Manufacturing Practices with workflows that implement the GMP requirements and with master records and batch production records that ensure quality during production.