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Redica Responds is an article series where we take common/unique questions from customers and industry events and answer them with our data. Use the following link to look at all previous Redica Responds articles. Since onsite inspections resumed in February of 2022, how many human drug GMP inspections have resulted in a 483? On February […]

If your company plans to market a drug product in Latin American countries, are you aware of the CMC challenges and also opportunities in Latin America? In this article, originally published on Sept. 13, 2020, Redica Systems Senior GMP Quality Expert Jerry Chapman examines the overall drug approval process in this part of the world. […]

Did the pandemic reduce the 483 issuance risk from pre-approval inspections (PAIs)? That is how it appears—especially in Asia—judging by the distribution of recent PAIs and the number of PAIs with only one FDA investigator. But a deeper look using Redica Systems data shows that the risk of receiving a 483 after a PAI may […]

Redica Responds is an article series where we take common/unique questions from customers and industry events and answer them with our data. Use the following link to look at all previous Redica Responds articles. My site has a quality system in place. Can I just leave it alone? FDA and other regulatory inspectors expect to […]

Updated Aug 2025 ALCOA stands for Attributable, Legible, Contemporaneous, Original and Accurate; ALCOA+ adds Complete, Consistent, Enduring and Available, while ALCOA-C further adds Current and Comprehensive. FDA investigators treat these attributes as the minimum data-integrity expectation under 21 CFR 211.68 and 211.100. Table of Contents Definition & regulatory basis ALCOA vs ALCOA+ vs ALCOA-C Technical […]

Redica Responds is an article series where we take common/unique questions from customers and industry events and answer them with our data. Use the following link to look at all previous Redica Responds articles. What are the top three issues seen in FDA 483 observations involving quality system requirements at medical device manufacturers? Per the […]

Are you certain that your cleaning validation processes would pass muster during your next inspection? Inspectors expect to see that your GMP operations include robust cleaning validation. This ensures that cleaning processes do not result in residue that could potentially contaminate the product.  What happens if your cleaning validation processes are found to be inadequate? […]

Redica Responds is an article series where we take common/unique questions from customers and industry events and answer them with our data. Use the following link to look at all previous Redica Responds articles. What can Redica Systems data tell us about enforcement trends involving media fills? What are the year-by-year numbers? Media fills are […]

GMP audits are conducted by third-party entities to ensure that a manufacturer is adhering to regulatory requirements. Audits can be carried out by internal teams within a company, consultants, or regulatory inspectors. This article will focus primarily on internal audits and audits conducted by consultants.  (Redica has some great resources in preparing for regulatory inspections, […]

Does your company use cloth wipes on equipment in aseptic manufacturing areas? Do you launder and reuse them? Can you document that the use of the wipes is not creating particulates? At the International GMP Conference held virtually in March 2022 co-sponsored by the University of Georgia at Athens and FDA, FDA Office of Regulatory […]