A review of recent FDA warning letters resulted in some familiar topics. Including: - Failure to follow and document laboratory controls: The firm did not ensure the integrity of data generated by its microbiology laboratory. - Failure of the Quality Unit: The Quality Unit failed to ensure that its manufacturing operations complied with cGMP and included some basics such as adequate document control, product quality complaint investigation extensions and documentation of deviations in testing methods. - Adulteration due to microbial contamination and non-sterility of products purported to be sterile. We are here to help! Let us know if we can help with quality and compliance issues in your firm. An internal audit with a new set of eyes can help identify hidden quality issues that you may be missing. Contact us today! #qms #qualitysystems #qualityassurance #qualitycontrol #dataintegrity
Quality Audit Consulting (QAC)
Pharmaceutical Manufacturing
Vacaville, California 189 followers
The Quality System and Audit Specialists ready to help you complete your 2024 audit schedule.
About us
With over 20 years of experience we help companies to remain compliant by specializing in performing Quality Audits for the Pharmaceutical, Biotech, Cosmetic and Medical Device Industries. We perform GMP, GDP, GLP, and GCP audits to FDA, EU, and ISO standards. Contact: info@qualityauditconsulting.com We are ASQ Certified Quality Auditors, ISO 9001:2015, and ISO 13485:2016 Certified. We perform Quality Management Systems audits for qualification of CMOs, CDMOs, Vendors, Suppliers and Internal Audits. We perform FDA Part 11 Electronic Records and Signatures and CSV Audits We perform GDP audits for Logistics and Warehouse Suppliers, Drug Depots, and Couriers. We perform Internal Audits for evaluation of internal Quality Systems. We perform gap analysis audits for ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 211
- Website
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http://www.qualityauditconsulting.com
External link for Quality Audit Consulting (QAC)
- Industry
- Pharmaceutical Manufacturing
- Company size
- 2-10 employees
- Headquarters
- Vacaville, California
- Type
- Privately Held
- Founded
- 2017
- Specialties
- GMP Audits, GXP, GDP Audits, Vendor Audits, Supplier Audits, CSV Audits, Part 11 Audits, 21 CFR 210, 21 CFR 211, ISO 9001, ISO 13485, 21 CFR 803, 21 CFR 812, ISO 14971, ICH Q7, ICH Q10, ICH Q8, ICH Q9, FDA, MDD, Quality Systems, QMS, MoCRA, and Cosmetic GMP
Locations
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Primary
Get directions
570 Buck Ave
Vacaville, California 95688, US
Updates
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The FDAs CDER Office of Compliance recently released its annual report from fiscal year 2023. Within this report they listed the most common citations in warning letters for cGMP related violations for Finished Product Manufacturers. Top five: 1. Responsibilities of the Quality Control Unit 2. Control and Testing of Components, Containers and Closures 3. Written Procedures; Deviations 4. Production Record Review 5. Equipment Cleaning and Maintenance Are you ready for your next inspection? Let us know if you would like a Mock Inspection performed. https://lnkd.in/g_f9swua
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Artificial Intelligence (AI) is here! How does this affect your medical device? What is the FDA's current thinking on AI and Software as a Medical Device (SaMD)? Find out more here: https://lnkd.in/gaJiT2q4 #ai #qms #qualitysystems #samd
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As a follow-up to Modernization of Cosmetics Act (MoCRA) new requirements for Cosmetic Facility Registration the FDA recently issued the following guidance in Nov. 2023: "Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing." https://lnkd.in/dDgwVF9Y
New FDA Cosmetic GMPs and the Modernization of Cosmetic Act (MoCRA) Check out our Blog! #cosmetics #cGMP #MoCRA #auditing https://lnkd.in/gdCG3Aw4
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FDA Webinar: Medical Device Sterilization and other interesting topics.
On Wednesday January 10 at 2 PM ET, the FDA will launch a town hall series to discuss the #MedicalDevice sterilization landscape, supply chain integrity, and forward-looking collaborative opportunities. Find out more. https://lnkd.in/dZrkbdSn
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FDA Guidance on DSCSA verification requirements was released in December 2023. Check out the highlights of the guidance here: https://lnkd.in/gFhwykya
Blog - Quality Audit Consulting
qualityauditconsulting.com
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Is your 2024 Audit Schedule Completed? Let us help! QAC can help manage your schedule, prioritize audits, schedule audits with suppliers, provide auditors, manage observations and corrective actions. Message us today! #QMS #Audit #suppliermanagement #auditmanagement #auditor #iso9001 #iso13485
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Do you need help completing your 2023 Audit Schedule on time? We can help! Visit our website: https://lnkd.in/gcynTDwz #auditschedule, #QMS, #vendorauditing, #supplierauditing #internalaudit
Quality Audit Consulting - Pharmaceutical, Vendor Audits, Medical Device Audits
https://qualityauditconsulting.com
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New FDA Cosmetic GMPs and the Modernization of Cosmetic Act (MoCRA) Check out our Blog! #cosmetics #cGMP #MoCRA #auditing https://lnkd.in/gdCG3Aw4
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Have you completed your 2023 audit schedule? We can help. Contact us now.
Supplier Management is Required Check out our latest Blog #management #suppliermanagement #supplierquality #qualityaudit https://lnkd.in/eAdUswMB
Quality Audit Consulting - Pharmaceutical, Vendor Audits, Medical Device Audits
https://qualityauditconsulting.com