“Learn how to ensure compliance with FDA’s Part 211 Subpart D equipment requirements for pharmaceutical manufacturing. This guide covers equipment design, installation, maintenance, cleaning, validation, and personnel training to prevent contamination and guarantee drug quality.”
CFR Title 21 — Part 211 Subpart D — Equipment Used in the Manufacture, Processing, Packaging, and Holding of Drugs. This part describes the measures that pharmaceutical manufacturers should follow for their equipment to be fit for purpose and installed, maintained, and calibrated to work as intended.
The focus of this article is to review the essential units covered in Subpart D and discuss how pharmaceutical manufacturers can apply these requirements to make sure that equipment is appropriate for its intended use.
Design and Build Your Own Equipment
At a minimum, the first requirement in Subpart D — design and construction to facilitate cleaning and maintenance suitable for its intended use. Therefore, equipment needs to be constructed from drug-compatible material and designed in a way that leaves no potential for contamination.
Accordingly, manufacturers must be mindful of the materials in the manufacture of their service equipment. That may include choosing inert or low-reactivity materials in contact with the drugs being manufactured or utilizing coatings or surface treatments that limit contamination and industry shall design the equipment to avoid contamination during processing. It can include a design with smooth surfaces for easy disinfecting or construction of seals and gaskets to hydraulic locks.
Installation and Maintenance
The second requirement in Subpart D is that equipment should be installed and maintained to perform properly. That is to say that its equipment must be installed correctly and continuously maintaining it and calibrating it so that it can work properly.
Manufacturers must draft a full equipment maintenance program in order to match this requirement. This program needs to include routine inspections of equipment that can detect any malfunctioning as well as routine cleaning and maintenance so that the equipment remain functional.
Manufacturers should also keep track of the calibration schedules for their tool to guarantee that they are calibrated regularly, consistently and accurately. Calibrating is to be done by trained individuals using proper calibrated equipment, and documentation should be kept as proof the equipment has its calibration according to a manufacturer.
Cleaning and Sanitization
The third provision under Subpart D is one requiring equipment to be cleaned and sanitized in a manner that does not allow for contamination. This implies that cleaning and disinfection of equipment between each use is necessary, and that these cleaning procedures must be validated to confirm they are effective.
Manufacturers need to establish and execute an overall cleaning as well as disinfection program to satisfy this demand. It must consist of specific steps for cleaning and disinfecting equipment and validation to confirm that the cleaning protocols are effective.
Personnel must also be trained on how to clean and sanitize, dressed in appropriate attire, and offered with supplies for cleaning.
Validation
Validation of equipment used in drug manufacturing is another part as addressed in Subpart D under requirement number four, which states that “Equipment should be qualified for its intended use.” In other words, manufacturers need to prove that the instruments they are using can consistently produce drugs according to specs.
Equipment validation programs must be created and implemented to meet this requirement. The program should also include specific protocols for demonstrating the proper function of equipment, as well as testing the drugs with which the equipment is used to ensure they meet required specifications.
All equipment validation activity should be documented, and records should also be maintained to demonstrate that certain pieces of equipment have been validated according to specification from the manufacturer itself.
Training
The last thing in Subpart D is that the personnel who are operating/maintaining/cleaning equipment must be trained on how to do this correctly. Manufacturers must enable personnel to successfully perform their duties, and this means furnishing them with the appropriate training and resources.
Manufacturers must develop and implement a training program for all personnel who handles equipment operation, maintenance, and cleaning as part of meeting this requirement. This program should consist continuous training and outlines all facets of equipment management, including maintenance as well as sanitation.
Training should be a mix of theoretical and practical according to the requirements of each individual. Staff should be trained in the appropriate use of machinery and adherence to maintenance and cleaning protocols.
Along with formal training, manufacturers should also make available training resources − for example in the form of manuals, videos and online training modules – to personnel. These can be leveraged to supplement training and provide personnel with additional information on how to operate, maintain, or clean the equipment.
Subpart D of Part 211 of the CFR
This specifically requires that the equipment used for drug manufacturing is appropriate and suitably installed, maintained, and calibrated to ensure proper function. An all–encompassing equipment management program to devise, implement aspects of design, installation, maintenance, cleaning, validation and training ensures that the equipment is fit for purpose and the end product of drugs meet specifications.
Conclusion
These requirements will be costly in terms of time and resources to implement, but the Return On Investment is large. Proper design, installation and maintenance of equipment ensures less chance of contamination and product failure while enabling manufacturers to meet regulatory requirements for drug manufacturing.
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