“Learn about FDA cGMP regulations for automatic, mechanical, and electronic equipment used in drug manufacturing. Ensure compliance with calibration, inspection, and documentation requirements.”
It is important to maintain the highest standards and comply with stringent regulations to guarantee drug safety and performance. Among them, Title 21, Chapter I of the Food and Drug Administration (FDA) guidelines — focusing on Subpart D under Part 211 for Use & Control of Equipment — contains extremely relevant information for those working in the field. Here is what you need to know about this regulation and why regular calibration, inspection, and documentation for automatic, mechanical, and sanitary electronic equipment that are used in the manufacturing process is essential.
Automatic/Mechanical/Electronic Equipment:
Sec.211.68(a) allows the option of utilizing automatic, mechanical, or electronic equipment in the manufacture, processing, packing, and holding of drug products. This consists of computers and associated systems which are used to provide certain functionality. Nonetheless, to make the equipment work properly, calibration, inspection and checks must be performed regularly according to a written program. It is mandatory to follow with this guideline as it preserves the quality and efficiency of the machinery used in pharmaceutical production.
Documentation and record-keeping:
Keep written records of calibration checks and inspection in accordance with the regulation. Records common to the written program, ensuring you are following through with it, easily outline that equipment is performing as intended. By providing a way to ensure compliance in the form of detailed documentation, regulators can follow up on any potential issue that may arise during manufacture.
In-The-Box Detection and Prevention of Systems:
Appropriate controls over computer or computer-related systems [§ 211.68(b)]: Changes in master production and control records, or other applicable documents, shall be instituted only by authorized personnel. To minimise errors, the input and output from computer systems (e.g., formulas, records, and data) should be verified for completeness and accuracy. The verification must be proportional to the complexity and dependability of the computer or software involving system.
If we refer to the principle of data integrity, we must keep backup files with original data entered into the computer system as per regulation. However, when data is removed by computerization or automation (e.g., for calculations carried out during laboratory analysis) a copy of the program used should be retained, supplemented with appropriate validation data. These alternative systems may be used in the event of a backup or if data changes, are accidentally deleted or lost for whatever reason (such as tapes or microfilm).
Ways to Improve Efficiency and Stay Compliant:
In addition to the other guidance in Subpart D, automated equipment that newly satisfies requirements on operation performance and blind checks by another person provided for related operations are addressed by additional sections (e.g., 211.101(c) or (d), 211.103, 211.182, or 211.188(b). On the other hand, adherence to the rules specified in Sec. 211.68 is essential. This means another personnel must come in and check that the machine completed the operation correctly, highlighting the importance of functioning and accuracy of equipment.
Conclusion
The guidelines for pharmaceutical CGMP regulations are specified in Title 21, Chapter I, Subpart D, Part 211 of the FDA guidelines. The regulations ensure the quality and reliability of automatic, mechanical, and electronic systems by focusing on periodic calibration and checks, as well as appropriate management of safety instruments. So, it is vital to follow those instructions to protect patient safety, improve product effectiveness, and maintain compliance with regulatory mandates.
Call BioBoston Consulting today or visit our website to discover how we can help you with your regulatory work.
