20 Frequently Used GMP Terms & Buzzwords That You Should Know

Know Your GMP Buzzwords

1. Active Ingredient – any component that provides a pharmacological activity or other direct effects in the diagnosis, cure, mitigation, treatment, or prevention of disease, or affects the structure or any function of the human body or animals.

2. Batch Record – A written and approved set of instructions that are used to produce a drug substance (e.g., active ingredient), drug product (e.g., final dosage form), or packaged and labeled product ready for distribution.

3. Change Control – A formal process for approval of a change to a document, equipment, or facility. The process includes the identification of the system requiring change, the reason for the change, assessment of the impact of the change on other systems, justification of the change with supporting documents, review and approval by department heads, and quality assurance.

4. Cleanroom HVAC – A mechanical system used for heating, ventilation, and air conditioning of pharmaceutical cleanrooms that provides low non-viable, and viable particulate levels specific to the room’s ISO classification.

5. Deviation – A deviation, also called quality event or variance, is a departure from the written instructions in production batch records, test methods, or standard operating procedures. Deviations may be planned if there is advanced knowledge that written instructions will not be able to be executed as written. In these cases, the “planned” deviation must be written and approved in advance of execution. Deviations are “unplanned” when a step in the written instructions was not performed as required or was mistakenly skipped. Unplanned deviations are written after the event occurred and are therefore retrospective in nature. Corrective and/or preventive actions may be required for planned and unplanned deviations.

6. Drug Potency/Strength – The formulated active strength of a drug product (e.g., 25mg, 50mg/mL) that is designed to be efficacious in treating an illness or other medical condition.

7. Drug Product – A finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo.

8. Environmental Monitoring – Environmental monitoring (EM) is the evaluation of the air and surface particulates in a pharmaceutical production cleanroom. Non-viable air samples (e.g., non-living organisms) are taken using specialized air collection pumps which counts particles of specific sizes. Viable-air samples (e.g., living organisms) are also collected using specialized air collection pumps and are incubated at certain temperatures and lengths of time to determine if organisms multiply. Viable surface sample collection uses particle settling plates and the plates are incubated to evaluate growth of organisms. Each cleanroom classification has specifications for acceptance of the results. This ensures that the cleanroom is operating within regulatory requirements.

9. Excipients – Inactive ingredients that make up the formulation for a drug product that aid in the processing of the active ingredient and enhancing/improving the stability of the product when stored per recommended or elevated temperature/humidity.

10. Expiry Date – A date assigned to a drug substance (DS) or drug product (DP) beyond which the DS or DP no longer meets one or more specification requirements and is not suitable for use. Once a DS or DP reaches its expiry date the date may not be extended. Expiration dates are set based on stability data.

11. Lot Number/Batch Number – Any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacturing of the drug substance, drug product, or packaged/labeled product can be determined.

12. Line Clearance – Systematic assessment performed by manufacturing employees or other departments that confirms that all of the raw materials, containers/closures, equipment, personnel, facility, and documentation are in place prior to the start of manufacturing a drug substance or drug product.

13. Method Validation – Analytical procedures (e.g., test methods) are used to test pharmaceutical products for release to the clinical and under stressed conditions in which product samples are placed in high temperature and high humidity environments. The analytical methods are validated by evaluating their accuracy, precision, specificity, limits of quantitation and detection, ruggedness and robustness against pre-approved specifications for each parameter. Regulatory agencies, such as the FDA, require the validation of analytical methods to ensure that testing results can be trusted.

14. Out of Specification (OOS) Investigation – An OOS investigation is initiated following the failure of one or more test results stemming from release testing of a pharmaceutical product or testing of a product on stability. An out of specification result typically requires notification of the sponsor (drug owner) and the initial investigation will include examination of whether any errors were made in preparing samples or standards as well as the performance of testing equipment. If a root cause of the failure was not identified a formal investigation will be conducted to examine possible hypotheses that could identify the root cause or multiple factors that together contributed to the failing result. The results of the formal investigation are reviewed by the testing lab and reported to the sponsor (drug owner). Investigations that point to the product as the cause of the failure may conclude in rejecting the release of the product to the clinic.

15. Product Retains/Retention Samples – Samples taken from a manufactured product and stored per approved temperature/humidity requirements for use in investigations into product release testing failures or clinical adverse events that may be linked to the product. Investigations may require examination of chemical, biological or visual quality attributes of the product. The terms product retains and retention samples are used interchangeably.

16. Product Specification – A written and approved document that list the tests to be performed for the GMP supplier’s release of the sponsor’s product. Specifications will include a list of the tests to be performed, the name and document number of the test methods to be used, and the numerical and descriptive limits assigned to each testing parameter. Common tests listed on a product specification include appearance, assay, related substances, identification by HPLC retention time or FTIR, and microbial limits testing.

17. Quality Agreements – A written and approved document detailing the responsibilities of a GMP supplier and the sponsor (e.g., drug owner). A well-written agreement will include all activities starting from specifications for raw materials through manufacturing, testing, and distribution of the product and the supplier’s quality systems that support these activities. A quality agreement will also provide instructions for dispute resolution and a list of companies that the supplier uses for outsourcing

18. Retest Date – A date assigned to a drug substance (DS) or drug product (DP) at which the DS or DP is required to be tested again to ensure that all quality attributes meet specifications. A retest date may be extended based on passing all testing requirements.

19. Stability Data – Data obtained from studies that expose the drug substance or drug product to extreme temperatures and humidity in order to determine the degradation pathways. Stability data is used to establish retest and expiration dates for drug substances and drug products.

20. Temperature Excursion – Temperature that a product is exposed to during storage or shipment that is either lower or higher than the temperature condition which might have an effect on the quality attributes of the product.

Takeaways & Conclusion

We hope this article serves you well as a quick guide and introduction to GMP lingo. Be sure to look out for future updates and additional parts to this article as we continue to add more terms and buzzwords to the list. If GMP terminology has you stumped or you have questions regarding any of our GMP services, please don’t hesitate to reach out to us via our contact form. We look forward to connecting with you!