The 10 Golden Rules for GMP Production – Part 1

by | May 31, 2023 | Compliance, FDA, GMP, Regulatory, Validation

Good Manufacturing Practices (GMP) is a system that consists of processes, procedures and documentation that ensures products are consistently produced and controlled according to set quality standards; for pharmaceutical production this is especially important. In general, there are 10 golden rules that apply in order to fulfill the GMP requirements. This article is part 1 of a 2-part series that discusses the first 5 rules and why they are important.

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

  1. Get the facility design right from the start. Critical aspects of this are having a smart production area layout that helps facilitate the sequence of operations, reduces the chances for contamination, and prevents mix ups and errors. Equipment should be designed, located, and maintained to suit its intended use.
  2. Validate processes. Proof in the form of testing and documentation is required to prove that equipment and processes consistently do what they are supposed to do to ensure the safety, quality, and effectiveness of every product. The two major components to this are the validation, which involves testing to verify that the equipment, facilities, utilities, or systems are installed and operated correctly, and change control, which is done to ensure that any change made to the equipment, facilities, utilities, or systems continues to maintain their validated state.
  3. Write good procedures and follow them. This step is a key requirement to have as procedures should be written in a clear, concise, and logical way that is easy for operators to follow. This helps reduce deviations in the process by ensuring that processes are run the correct way.
  4. Identify who does what. Assigning accountability and clearly defined roles to employees, that way there are no misunderstandings on how to perform tasks each day. These responsibilities and roles should be defined in applicable procedures.
  5. Keep good records. Having good records and documentation practices allows each activity during the batch manufacturing process to be tracked and controlled. Documentation should follow the Good Documentation Practices (GDP) and ALCOA rules (Attributable, legible, contemporaneous, original, and accurate). Any mistakes, incidents, or deviations that happen should be documented with relevant details and information. All records that are created throughout the batch should be retained so that the information is not lost or destroyed. For specific batch documentation records, these must be kept for one year after the expiry of the batch to which it relates or at least five years after certification of the batch by the Authorized Person, whichever is longer.

If you need support in understanding how 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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