Outsourcing Trends

Outsourcing Trends

5 Commonly Overlooked Laboratory Checks for your FDA cGMP Audits

This blog post is a guest post from Edword Simpson, technical engineer at Science Exchange lab, RS Calibration.


Ensuring that everything in your laboratory is ready for any upcoming audit is a nail-biting task. The annual FDA audit for compliance with regulatory guidelines, like the current goods manufacturing process (cGMP) is especially tedious. Manufacturing processes and equipment for pharmaceuticals are regulated very carefully by the FDA and require strict adherence to industry standards.


Here are five things that aren’t always given the attention they require and could easily result in regulatory action for failing to comply with cGMP:

  1. Thorough Product and Equipment Training – The ‘c’ in cGMP is for current, and keeping up-to-date requires regular investment in new equipment. Make sure your employees are thoroughly trained in procedures and safety precautions for operating, maintaining, calibrating and cleaning them all. This prevents errors and contamination, and if your staff is familiar with all the safety precautions, it reduces the likelihood of workplace injuries too.
  2. Refresh Your Employees’ Knowledge – Your staff can’t perform their duties to a minimum standard if they don’t know, or don’t remember, what the standard is. Make sure there are regular reminders of the regulations and proper calibration, which are well-explained and easily accessible. These can be in the form of posters around workspaces or periodic e-mails and refresher courses. The idea is to ensure the requirements are stressed often enough to prevent lapses in proper operational procedures and calibration.
  3. Keep Up-to-Date and Organized Records – There should be a strict process in place for keeping and regularly updating records for any significant events, including errors and calibration results, equipment malfunctions, damaged parts and their replacements. Other than just your laboratory equipment, you should also have a comprehensive and detailed database to keep track of personnel issues like illnesses and injuries, mishaps and the like. All relevant information should be well-organized and security measures set in place to prevent unauthorized access.
  4. Regular Maintenance Schedule – Making sure that your equipment is always performing within the parameters requires periodic maintenance. Best practices for routine maintenance include a suitable schedule for calibration, cleaning and pre-emptively replacing parts and equipment that are nearing the end of their serviceable life. A detailed roster with a systematic checklist should be in place for employees tasked with maintenance. Any expired products should be removed off the shelf and disposed of properly to avoid getting them accidently getting mixed with the ones scheduled to be released to the market.
  5. Analyze Your CAPA System Procedure – We’ve all heard the proverb “a stitch in time saves nine,” and that’s exactly what a Corrective and Preventive Actions system does for your laboratory. Investing in a CAPA is almost essential for making sure you nip minor complications in the bud before they can do major damage. It’s not a ‘set-it-up and forget about it’ system, and you should update the processes periodically to keep up with any changes or shortcomings. Any errors that have made it through can be traced back through the system to find the point of occurrence, so another parameter can be added to prevent it the next time around. As with any other process, any errors and corrective measures need be documented in detail and periodically reviewed for improvement.

It isn’t necessary for your laboratory to have accreditation to ISO 17025 standards, but the FDA’s regulations are similar and it’s good to be up-to-date with the standards. The scope of FDA requirements for compliance with cGMP for Finished Pharmaceuticals covers everything from facility and equipment, to organization and personnel. The complete list of regulations is published under Title 21 of the Code of Federal Regulations.

Author Bio: Edword Simpson is a seasoned Calibration and Technical Engineer working for RS Calibration Inc. in Pleasanton, CA. Over the course of his career, he has developed a special knack for finding faults in machines and does not rest until they are rectified. As far as Edword is concerned, the job isn’t done till the machine works perfectly. He loves to share information about how machines work so if you have any questions you can reach him through his Science Exchange storefront: https://scienceexchange.com/labs/rs-calibration-service


Science Exchange Team


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