The 10 golden rules for GMP production: Part 2

by | Jun 12, 2023 | Compliance, FDA, GMP, Regulatory, Validation

Good Manufacturing Practices (GMP) is a system that consists of processes, procedures and documentation that ensures manufacturing products are consistently produced and controlled according to set quality standards. For pharmaceutical production this is especially important as the drugs manufactured are injected directly into patients. In general, there are 10 golden rules that apply in order to fulfill the GMP requirements. This article is part 2 of a 2-part series and discusses the first 5 rules and why they are important.

The second 5 golden rules for GMP production of pharmaceutical drug production are:

  1. Train and develop staff. Training in general GMP practices and concepts as well as specific training for jobs is required for all applicable personnel who will be performing activities. during the manufacturing processes. Often this takes the form of a hands on 3-step training where the procedure is explained and demonstrated by a trainer, the operator practices with the supervision and help of a qualified trainer, and finally the operator is required to perform the activity on their own to show they are proficient at performing the task.
  2. Practice good hygiene. Having an effective cleaning and sanitation program that meets the necessary standards for the products manufactured is necessary to reduce the risk of potential contamination. This applies to everything from requiring employees to wash their hands before entering the production area, to cleaning rooms, to ensuring that operators are not sick, to removing trash and waste materials from the area.
  3. Maintain facilities and equipment. Having procedures that include the schedule and activities for proper maintenance of facilities, utilities, and equipment is essential to prevent unexpected breakdowns, reduce the risk of contamination, and maintain the validated state. Proper records must be kept for all maintenance activities indicated what was done and when it happened.
  4. Build quality into the whole product lifecycle. Having proper controls in place to ensure that the materials and components used are approved, records and procedures that ensure the manufacturing process is done consistently and up to the quality standards required. This includes having a master record that includes procedures on how to perform the activities, individual batch records to show that the process followed aligned with the master record, and proper schedules for ensuring that the area and equipment are maintained in their validated and clean state. Once lots have been process, it is important to ensure that rejected material is not placed in the same area as approved material to prevent accidental release. Procedures for how to properly store and handle product for both cases should be established for this reason.  
  5. Perform regular audits. Ensure procedures are being properly followed and activities performed align with written procedures by performing audits to guarantee GMP compliance.

If you need support in understanding how to GMP practices apply to your processes, the experts at EMMA can help! Call us at 248-987-4497 or email us at to learn more.

Patel, K., & Chotai, N. (2011, April). Documentation and records: Harmonized Gmp Requirements. Journal of young pharmacists : JYP.

PhramOut. (2021, October). White Paper: The 10 golden rules of GMP.

Jacob Wright

Jacob Wright

Jacob Wright is a Quality Engineer at EMMA International with expertise in regulatory compliance, process validation, and quality management systems. He received his Bachelor of Science and Master's degrees in Biological/Biosystems Engineering from Michigan State University, where he developed a deep understanding of living organisms and engineering systems. Jacob's strong commitment to quality, attention to detail, and risk mitigation skills make him an effective advocate for regulatory compliance and product safety.

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