GMP News

EMA Guidance on Implementing Shortage Prevention Plans

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EMA issued guidance describing how marketing authorisation holders should establish, maintain and update Shortage Prevention Plans for prescription-only human medicines in EU/EEA countries. Plans may group products sharing a supply chain, provided product-level minimum data can be supplied within two days of a request. The guidance sets out product information, patient-impact assessment, supply-chain mapping, shortage history, risk classification and proportionate management measures. It also identifies additional crisis-related information for listed critical medicines, including production and supply capacity, alternative sites and minimum stock levels. Plans should be updated after relevant changes and may form part of annual product quality review.

2024 PDA/FDA Conference Focuses on Effective Quality Systems

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FDA and the Parenteral Drug Association (PDA) will host the 33rd Joint Regulatory Conference on September 9–11, 2024, emphasizing effective quality systems and an ongoing state of control across the product lifecycle. The program focuses on robust quality systems, facilities, processes, raw material quality, supplier relationships, industrial modernization, and quality risk management as foundations for CGMP compliance. It will use case studies to address sustainable compliance, quality and supply consistency, and international collaboration. Planned discussion topics include investigations, cybersecurity and data integrity risks, supplier selection and auditing, current manufacturing technologies, CGMP guidance updates, aging facilities, quality assurance authority, and quality-control laboratory risk reduction.

B. Braun Recalls Three Sodium Chloride Injection Lots for Zinc Oxide Particulates

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B. Braun Medical Inc. voluntarily recalled three lots of 0.9% Sodium Chloride Injection USP, 100 mL in 150 mL PAB® containers, nationwide at the hospital, healthcare facility, and user levels. The recall followed detection of particulate matter identified as zinc oxide. Affected lots are J6B435, J6B444, and J6B457, with expiration date 30APR2027; distribution occurred from February 27, 2026 through August 3, 2026. The company warned that intravenous administration could cause life-threatening vascular, immune, organ, or blood-cell effects. No serious injuries, deaths, or other adverse events had been reported. B. Braun is notifying distributors and customers and arranging returns and replacements.

FDA and PDA Announce 2026 Joint Regulatory Conference

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FDA and the Parenteral Drug Association (PDA) will host the 2026 PDA/FDA Joint Regulatory Conference, “Excellence in CGMP: Ensuring Quality, Protecting Patients,” in Washington, D.C., from September 14 through 16, 2026. The program is intended to provide practical insights on CGMP compliance, quality systems, risk-based manufacturing, supply chain oversight, and industrial modernization through expert discussions and case studies. Listed subjects include FDA center and office updates, artificial intelligence in regulatory oversight and inspection readiness, pre-approval inspections, CAPA and effectiveness checks, data governance, quality risk management, change management, workforce development, CGMP training, and global regulatory collaboration. Registration and a full agenda are available through PDA.

FDA Warning Letter: Spa De Soleil cited for water system, component testing, validation, and quality unit deficiencies

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FDA inspected Spa De Soleil’s Sun Valley drug manufacturing facility in January 2026 and found significant CGMP violations affecting OTC topical drug production. FDA states the firm inadequately investigated 51 water-system microbiological OOL and chemical OOS results recorded from May 2024 through July 2025, including gram-negative recoveries, conductivity failures, and total organic carbon failures. Investigations relied on resampling and retesting without identifying microorganisms or adequately evaluating affected products. The water system contained dead legs, threaded fittings, Teflon tape, and ball valves, and monitoring did not reflect production schedules. FDA also found inadequate identity and impurity testing of incoming high-risk components, including controls for methanol, DEG, and EG, plus unverified reliance on supplier certificates of analysis. Manufacturing processes lacked adequate validation, and batch records omitted critical processing parameters and equipment identification. An alternative microbiological method was not shown equivalent to or better than USP methods. FDA further cited ineffective quality-unit oversight, insufficient contract-laboratory qualification, absent annual product quality evaluations, and unvalidated cleaning procedures. The February 2026 response lacked supporting documentation and adequate corrective-action evidence; similar violations had been cited in 2021.

FDA Warning Letter: Suretec Innovations cited for component, microbiological, and quality-unit controls

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FDA states that its March 2–5, 2026, inspection of Suretec Innovations’ Arizona facility found significant CGMP violations in OTC drug manufacturing. The firm did not adequately identity-test incoming components, including the API, and relied on supplier certificates of analysis without establishing their reliability. FDA also found inadequate finished-product microbiological testing: the non-compendial method lacked appropriate incubation times, method suitability, controls, and validation. The quality unit did not thoroughly investigate microbial out-of-limit results from a system supplying a manufacturing component; material from that system continued to be used in products that were released. FDA further found that the quality unit lacked adequate authority and oversight, including for production and process procedures, system qualification, stability testing, defined quality-unit responsibilities, and sufficient qualified personnel. FDA judged the firm’s responses inadequate because they lacked key documentation, implemented investigation controls, and retrospective assessments of distributed product quality. FDA requested material-system and supplier reviews, component and retain-sample testing, investigation remediation, risk assessment, CAPA, and comprehensive quality-unit remediation.

FDA Warning Letter: API Process Validation, Batch Records, Analytical Methods, and Stability Deficiencies

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What happened FDA states that its records review identified significant CGMP deviations at Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd., an API manufacturer. The firm manufactured and distributed APIs to U.S. 503A compounding pharmacies without adequate process validation; it had described the APIs as still in development and said formal documents, including SOPs, were not finalized. … Read more

FDA Outlines Outsourcing Facilities Annual Study Findings and Actions

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What happened The FDA Compounding Quality Center of Excellence conducts the Compounding Outsourcing Facilities Annual Study to understand industry perspectives, challenges, and supplier-purchaser dynamics. Each study combines a survey, stakeholder discussions, and analysis of existing data; a research partner works under FDA direction, and survey and discussion data are anonymous to FDA. Published summaries describe … Read more

FDA Warning Letter: Zydus Lifesciences cited for contamination, aseptic processing, and PPQ deficiencies

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What happened FDA inspected Zydus Lifesciences Limited in Gujarat from April 15 to 23, 2024, and cited significant CGMP violations involving investigations, aseptic processing, and process validation. FDA stated that multiple cross-contamination events over about three months were linked to inadequate cleaning of shared equipment. Investigations did not cover all potentially affected batches, equipment, product-contact … Read more

Baxter Recalls One Sodium Citrate Solution Lot for Potential Fiberglass Particulates

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What happened On August 25, 2026, Baxter International announced a voluntary nationwide recall of one lot of Anticoagulant Sodium Citrate Solution USP, 250 mL VIAFLEX Plastic Container, because of potential particulate matter identified as fiberglass. The affected lot is Y493475, product code 2B7867Q, NDC 0338-9669-01, expiring December 31, 2027. It was distributed July 2-11, 2026, … Read more