Updated: Aug 4
The maintenance of high standards and adherence to strict regulations is crucial to ensure the safety and efficacy of drugs. One such regulation that plays a vital role in maintaining quality is Title 21, Chapter I of the Food and Drug Administration (FDA) guidelines, specifically Subpart D under Part 211, which focuses on the use and control of equipment. This article delves into the key aspects of this regulation and highlights the importance of routine calibration, inspections, and proper documentation to ensure the proper functioning of automatic, mechanical, and electronic equipment used in the manufacturing process.
Automatic, Mechanical, and Electronic Equipment:
Under Sec. 211.68(a), the regulation permits the use of automatic, mechanical, or electronic equipment in the manufacture, processing, packing, and holding of drug products. This includes computers and related systems that perform specific functions. However, to ensure the equipment's proper performance, routine calibration, inspection, and checks must be carried out as part of a written program. Compliance with this requirement is vital to maintain the integrity and reliability of the equipment used in pharmaceutical manufacturing.
Documentation and Record-Keeping:
The regulation emphasizes the importance of maintaining written records of calibration checks and inspections. These records provide evidence of adherence to the written program and demonstrate that the equipment is functioning properly. Accurate documentation ensures traceability and accountability, enabling regulators to verify compliance and address any potential issues that may arise during manufacturing.
Control and Security of Computer Systems:
Sec. 211.68(b) highlights the need for appropriate controls over computer or related systems. Only authorized personnel should be allowed to institute changes in master production and control records or any other relevant records. Input and output from computer systems, including formulas, records, and data, should be checked for accuracy to minimize errors. The frequency and extent of verification should be commensurate with the complexity and reliability of the computer or related system.
In line with data integrity principles, the regulation requires maintaining backup files of data entered into the computer system. However, in certain instances where data is eliminated by computerization or automation, such as calculations performed in laboratory analysis, a written record of the program should be maintained alongside appropriate validation data. To safeguard against alteration, inadvertent erasures, or loss of backup data, alternative systems such as duplicates, tapes, or microfilm can be employed.
Enhancing Efficiency and Compliance:
In addition to the guidelines provided in Subpart D, automated equipment used for specific operations addressed by other sections, such as §§ 211.101(c) or (d), 211.103, 211.182, or 211.188(b)(11), can satisfy the requirements related to operation performance and checking by another person. However, compliance with the regulations outlined in Sec. 211.68 is essential. It is crucial that one person verifies and ensures that the automated equipment has correctly executed the operation, reinforcing the significance of proper equipment functioning and accuracy.
The regulations specified under Title 21, Chapter I, Subpart D, Part 211 of the FDA guidelines serve as a critical framework for maintaining current good manufacturing practices in the pharmaceutical industry. By emphasizing routine calibration, inspections, and the appropriate control of equipment, the regulations aim to ensure the quality, integrity, and reliability of automatic, mechanical, and electronic systems used in drug manufacturing. Adherence to these guidelines is of paramount importance to safeguard patient safety, enhance product efficacy, and maintain compliance with regulatory standards.