Getting to GxP Compliance (And Staying There) - A preview of a NEW Application Note

Paul Daniel
Sr. Regulatory Compliance Expert
May 16, 2013
Life Science

In this blog post, I'll focus on the critical regulations for pharmaceutical manufacturing that focus on Standard Operating Procedures and Training. To maintain GxP compliance, you need to integrate procedures that are part of managing your continuous monitoring system into your existing quality system. Although I use Vaisala's own system software viewLinc as a reference point, the basic principles apply to any environmental monitoring system used in a regulated environment.


Regulations on Standard Operating Procedures & Training

It is a primary expectation of regulated environments that written procedures for GMP processes be established, followed, and maintained under revision control as stipulated by 21 CFR Part 211, Subpart H -- Holding* and Distribution of Finished Pharmaceuticals." (*The FDA has previously stated that it interprets the word “Holding” as applying to all parts of the manufacturing process.)

Regarding the establishment of written procedures, refer to 21 CFR 211.142 which states: “Written Procedures… shall be established and followed." They shall include: "Storage of drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity of the drug products are not affected." Furthermore, 21 CFR 820.40 (Quality System Regulation - Control Documents) states: “Each manufacturer shall establish and maintain procedures to control all documents that are required…”
For proper support of your environmental monitoring system, you need to have SOPs in place for both operation (basic usage) and administration of the system. Ideally, you will have dedicated SOPs within your Quality System governing other supporting activities such as Calibration, Training, Validation, and Change Control. If you don’t have SOPS for these activities, you can address these support activities (as they apply to viewLinc only) in your viewLinc SOPs. All SOPs must be treated as controlled documents and provided with controls for approvals and revisions.

Of course, if you are creating SOPs (and as we saw above, you must do so in a process or holding environment that will affect the "identity, strength, quality, and purity of the drug products," you will also train the personnel (including temporary and contract personnel) who are going to execute and document any procedures they perform. Even though the creation of a Training SOP is not required as part of 21 CFR 211.25, creating standard training procedures will show a significant commitment to the regulations that require training... specifically: 21 CFR 211 Subpart B - Organization and Personnel.

The regulations on Organization and Personnel state: “Each person engaged in… holding drug product shall have the… training… to enable that person to perform the assigned functions.Training shall be in the particular operations that the employee performs… including the… written procedures required by these regulations...” Furthermore, 21 CFR 820.25b, which describes Personnel in Quality Systems states: “Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.”

Every employee using the Vaisala continuous monitoring system should be trained to the section(s) of the SOPs that apply to their job. And, as in all things FDA-regulated, if it isn't documented, it didn't happen, so you will need to ensure that written records of the training are maintained. A rule of thumb I've seen throughout the industry is to retain documents pertaining to GMPs for the latter date of either 1 year beyond a product's expiry date, or 3 years beyond the product's distribution date.

In our new Application Note: "The Care & Feeding of an Environmental Monitoring System" we will expand on the theme of integrating a continuous monitoring system into your Quality Management System, with a particular focus on the regulations pertaining to these elements of your QMS:

  1. SOPs
  2. Training
  3. Validation
  4. Calibration
  5. Change Control

If you have any questions, please email me at [email protected]

Paul Daniel, Senior Regulatory Compliance Expert

Paul Daniel

Senior Regulatory Compliance Expert

Paul Daniel is the Senior Regulatory Compliance Expert at Vaisala. He has worked in the GMP-regulated industries for over 20 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems.

At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications.

Paul also shares his GMP experience through regular blog contributions, webinars, and seminars around the world. Paul’s expertise in the demanding GxP world is applicable to any industry where measurement is critical to product quality. Paul is a graduate of University of California, Berkeley, with a bachelor's degree in biology.

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