GMP News

FDA Announces Year Five of the CMC Development and Readiness Pilot

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FDA states that it will begin accepting requests on October 1, 2026, for year five of the Chemistry, Manufacturing, and Controls Development and Readiness Pilot. The program supports selected CBER- and CDER-regulated products under investigational new drug applications with accelerated clinical development timelines. Accepted sponsors may discuss CMC product development strategies and goals with FDA review staff during two predesignated Type B meetings, with follow-up discussions available for questions or clarification. FDA will select no more than nine proposals per year. Participation requests must be submitted as IND amendments with the specified cover-letter statement. The pilot will continue through fiscal year 2027.

FDA Human Drug Compounding Information and Oversight Resources

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FDA describes human drug compounding as the combining, mixing or altering of drug ingredients by specified licensed professionals, or supervised personnel at an outsourcing facility, to create medication tailored to an individual patient’s needs. It states that compounded drugs are not FDA-approved and are not reviewed by the agency for safety, effectiveness or quality before marketing. FDA says its compounding program seeks to protect patients from poor-quality compounded drugs while preserving access to lawfully marketed products for patients with medical need. The page provides links on laws, policies, risk alerts, bulk drug substances, outsourcing facilities, registrations, inspections, recalls, state information and the Compounding Quality Center of Excellence.

FDA Warning Letter: Bausch & Lomb cited for aseptic processing and contamination-control deficiencies

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FDA states that its March 12–20, 2026 inspection of Bausch & Lomb’s Tampa drug manufacturing facility identified significant CGMP violations involving sterile prescription and OTC products. Environmental and personnel monitoring did not sufficiently cover significant locations, procedures were inadequate, and cracked media could not adequately support growth of recovered contamination. From 2023 to 2025, the firm routinely recovered out-of-limit microorganisms in ISO 5 areas, including gram-negative organisms associated with water sources, but continued production without adequate CAPA. FDA also cited inadequate investigations of microbiological departures and adverse trends, insufficient microorganism identification, RABS and barrier-design deficiencies, and smoke studies that did not sufficiently demonstrate unidirectional airflow. Operators were repeatedly observed using poor aseptic techniques during filling. Media fills were substantially smaller than commercial batches and did not adequately represent contamination risks; a July 2025 media fill failed with fungal and spore-forming bacterial contamination. FDA further stated that management oversight was ineffective and the quality unit lacked sufficient authority or implementation of its responsibilities.

EMA reports on international API inspection programme, 2017–2024

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EMA’s report reviews the International API Inspection Programme from 2017 to 2024. Across 13 participating authorities, information was shared on 936 inspected sites and 1,684 inspections, approximately 50% more inspections than in the previous period. Of the sites, 644 (69%) were of shared interest; inspection reliance was reported for 107 sites. Authorities conducted 91 remote inspections, while 27 joint inspections covered 25 sites. Duplicate inspections affected 32% of sites and were more frequent following non-compliant outcomes. The report identifies legal, confidentiality, language, technical and resource barriers to report sharing and centralised data exchange. It recommends timelier information sharing, improved report usability, stronger reliance practices and action on duplication.

Centric Compounding Recalls Six Injectable Lots for Elevated Endotoxin

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Centric Compounding voluntarily recalled six lots of compounded Glutathione 200 mg/mL, Myer’s Cocktail, and Tri-Immune Boost injectable products to the consumer level after finding that they were compounded with Glutathione API containing elevated endotoxin levels. The affected products are 30 mL multidose vials distributed nationwide to patients and prescribers. The company reported nine accounts of symptoms including fever, chills, chest pain, nausea/vomiting, headache, and/or malaise. It warned that injectable products with elevated endotoxin could cause serious events, including hypotension, inflammatory reactions, anaphylactic shock, and death. Customers are being notified, replacements arranged, and consumers instructed to stop using and discard affected vials.

FDA Compounding Policy and Rule Resources Updated Through September 2026

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The FDA page compiles policy documents and related materials governing human drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. Its latest listed item is final guidance dated September 4, 2026 on temporary policies for compounding certain starter parenteral nutrition drug products for neonates. It also lists an April 30, 2026 Federal Register notice on the section 503B clinical-need list for bulk drug substances, with an FDA statement proposing exclusion of semaglutide, tirzepatide, and liraglutide. Earlier entries cover bulk substances, temporary parenteral compounding policies, outsourcing facilities, insanitary conditions, current good manufacturing practice, reporting, distribution, and repackaging. The page identifies its content as current as of September 9, 2026.

FDA Warning Letter: Happy Farm Botanicals cited for component testing, stability, and validation failures

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FDA states that its March 30 to April 2, 2026, inspection of Happy Farm Botanicals’ OTC drug facility found significant CGMP violations. The firm did not perform specific identity testing on incoming raw materials and components, including APIs, before use; one API lot received only organoleptic testing and was used in finished batches. FDA also found a lapsed supplier requalification and no adequate validation of supplier test analyses. The stability program lacked adequate chemical and microbiological support for labeled expiry periods: accelerated studies lacked controlled humidity records, several timepoints were unavailable, and failing viscosity results in accelerated and long-term studies were not investigated. FDA’s quality unit findings included absent process validation for OTC products, absent cleaning validation for non-dedicated equipment, inadequate investigation and CAPA for recurring gasket seal failures, and inappropriate API content release limits. FDA deemed the firm’s response inadequate and noted that process and cleaning validation commitments from the 2024 inspection remained incomplete. The firm reported plans to cease production of the specified drugs at this facility.

Revised procedure for coordinating GMP inspections of centrally authorised products

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Version 3 of the guideline, adopted in April 2026 and entering into force on 10 September 2026, describes EMA coordination of GMP inspections conducted by EEA competent authorities for centrally authorised products. It covers pre-approval inspections, for-cause inspections and routine risk-based re-inspections, including inspection triggers, authority selection, preparation, site contacts and report submission through IRIS. The revision clarifies that, where a Supporting Authority is unnecessary, one Authority may perform both leading and supporting roles. Applicants should identify proposed manufacturing, testing and batch-release sites before submission, and all listed sites should be inspection-ready and compliant with EU or equivalent GMP from submission.

FDA Warning Letter: Jabil sterile manufacturing deficiencies involving fungal contamination and quality oversight

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FDA’s February 23 to March 6, 2026, inspection of Pharmaceutics International, Inc., a Jabil company and contract manufacturer of sterile injectables, identified significant finished-pharmaceutical CGMP violations. FDA found inadequate investigations of a sterility failure involving Ustilago spermophora and recurring fungal recoveries in Grade A filling areas, including insufficient root-cause analysis, trend evaluation, and CAPA. The quality unit did not ensure complete documentation of aseptic interventions; one batch record documented 12 interventions although records indicated approximately 200 occurred. FDA also cited inadequate disinfectant efficacy studies and failure to perform process validation after adding a production step. Airflow visualization studies were deficient or omitted following RABS modifications, and some interventions lacked adequate smoke visualization. Environmental monitoring used insufficient sampling techniques and locations. Classified areas also had peeling paint and plastic debris. FDA considered the company’s responses inadequate because they did not sufficiently address contamination sources, systemic investigation weaknesses, quality oversight, or sustainable remediation.

FDA Warning Letter: Unapproved Injectable Peptide Drugs Marketed by Royal Peptides

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FDA identified violations during a July 2026 review of Royal Peptides LLC’s website. FDA determined that products marketed as Tirzepatide, Semaglutide, Retatrutide, SS-31 (Elamipretide), PT-141, Tesamorelin, and BIMORELIN were drugs based on claims concerning metabolic regulation, weight loss, mitochondrial function, hormone modulation, recovery, and sexual dysfunction. FDA stated that these products were unapproved new drugs because they were not generally recognized as safe and effective for the labeled uses and had no approved applications in effect. Although product labeling included statements such as “for research use only” and “not for human or animal consumption,” FDA cited website evidence indicating intended human drug use. FDA also noted that the firm marketed bacteriostatic water with a peptide guide and calculator that collectively provided means to prepare an injectable drug for human administration. The letter does not describe a manufacturing-site inspection or identify specific CGMP, laboratory, validation, facility, or quality-system deficiencies.