Global Regulatory Monitor
Regulatory News, Week 4 · 2026/8

Based on the previous WHO desk assessment and on the GMP evidence received and reviewed, it is considered that a desk assessment is acceptable in lieu of a WHO onsite inspection. The site Farmabios S.p.A. located at Via Pavia, 1, 27027 Gropello Cairoli, Pavia, Italy is considered to be operating at an acceptable level of compliance with WHO GMP guidelines. This WHOPIR will remain valid for 3 years, provided that the outcome of any inspection conducted during this period is positive.

(AIFA) — 10th 14 March 2025

Based on the GMP evidence received and reviewed, it is considered that a desk assessment is acceptable in lieu of a WHO onsite inspection. The site Neuland Laboratories Limited, Unit-I located at Sy. No.: 291, 346P, 347, 348P, 473, 474, 490/2, Veerabhadraswamy Temple Road, Domadugu Village, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Pin code 502 313, Telangana State, India, is considered to be operating at an acceptable level of compliance with WHO GMP guidelines for APIs. This WHOPIR will remain valid for 3 years, provided that the outcome of any inspection conducted during this period is positive.

USFDA — 18–22 March 2024

EDQM/ ANSM — 7-9 June 2023

Based on the areas inspected, the people met and the documents reviewed, and considering the findings of the inspection, including the observations listed in the Inspection Report, ACDIMA BioCenter located at 18th Salah Shimat St, Sweifieh, Amman, Hashemite Kingdom of Jordan was considered to be operating at an acceptable level of compliance with WHO GCP and applicable BE guidelines. The deficiencies observed during the inspection, as listed in the full report, were addressed by the ACDIMA BioCenter to a satisfactory level before the publication of the WHOPIR. This WHOPIR will remain valid for 3 years, provided that the outcome of any inspection conducted during this period is positive.

A presentation was provided that explained the organization’s activities in detail. ACDIMA BioCenter operated in accordance with the principles of GCP and GLP, as endorsed by JFDA in the declaration letter (Appendix 2 of CRO Master File: ACDIMA BioCenter JFDA GCP–GLP Certificate). The CRO indicated the outcome of the previous WHO inspection as accreditation. The CRO was notified and subsequently removed the incorrect information from its website during the inspection. The CRO committed to revising the other relevant documentation, including the Quality Manual. …

The ACDIMA BioCenter Software Validation Master Plan effective 28 December 2025, was established to ensure that computerized systems were suitable for their intended purpose and were validated, operated, and maintained in accordance with GCP and GLP principles, as appropriate. Risk assessments were required and were performed using the Failure Mode and Effects Analysis (FMEA) tool, in accordance with the respective SOP, every two years or upon installation of new software. An inventory of all computerized systems on the network was available. …

The CRO had established appropriate QA and QC systems, supported by written SOPs, to ensure that trials were conducted and that data were generated, documented, and reported in compliance with the protocol, GCP, GLP, and applicable regulatory requirements. A Quality Manual, dated 18 March 2026, was provided and reviewed. …

The archive facility had been successfully inspected during the previous inspection. It was confirmed that adequate access control was in place, with authorized personnel clearly identified. Records of file movements were maintained and reviewed.

During the inspection, a tour of the facility was conducted. On Day 1, the CPU on the 3rd floor was visited during sample collection. The facilities were clean and equipped with adequate lighting, ventilation, and environmental controls. Floors, walls, and workbench surfaces were easy to clean and decontaminate. Bioequivalence studies were conducted under conditions that ensured the safety of subjects. The selected site was appropriate for the level of risk involved. The CRO had sufficient space to accommodate the personnel and activities required to perform the studies. …

A sufficient and qualified team of medical, paramedical, technical, and clerical staff was available to support the trial and respond effectively to foreseeable emergencies. At all stages of the trial, including during night hours, qualified and trained personnel were present to ensure that subjects’ rights, safety, and well-being were safeguarded and that appropriate care was provided in cases of emergencies. Contract workers were engaged for specific activities to complement the team’s capabilities. …

The clinical phase of the studies was performed at the CRO premises. The inspection team was informed that the facility had expanded its operations by establishing a second clinical site and a dedicated hospital-based facility for studies requiring hospital care, participant admission, and continuous 24-hour medical supervision. The CPU was equipped with 144 beds. Systems were in place in the accommodation areas to enable subjects to alert CRO staff as needed. Each subject was provided with a badge and a bracelet indicating the study number and subject number. …

A suitable clinical laboratory was used for sample analysis. The laboratory was accredited by JFDA and ISO 15189 (accredited in 2020; last assessment conducted on 9 February 2026). Hematological tests, urine analysis, and other investigations were performed during the clinical trial as specified in the study protocol. Procedures for sample labeling, receipt, storage, and chain of custody ensured full traceability and integrity. Samples received from the clinical site were handled by laboratory technicians, accompanied by the corresponding documentation. …

The study trial was approved by the Independent Ethics Committee (IEC), with the first amendment approved on 26 May 2025 and the second amendment on 29 May 2025. The second amendment was implemented prior to dosing, after the screening phase, and involved a change in the volume of water administered during dosing from 20 ml to 40 ml, in accordance with WHO recommendations. The independence of the IEC from the sponsor, investigator, and CRO was verified through a review of the committee membership list. …

The study was monitored by an external monitor employed by the sponsor. Pre-study, in-study, and post-study monitoring visits were conducted. The monitor prepared a written report after each site visit and communicated any issues to the CRO and the sponsor in a timely manner, including during the study when necessary, to allow prompt corrective action. The corresponding communications and corrective actions were documented. The monitor was appropriately qualified and ensured that the study was conducted in accordance with applicable requirements.

The Principal Investigator was responsible for the clinical conduct of the study, including the clinical aspects of study design, administration of the investigational products, communication with local authorities and with the ethics committee, and signing the protocol as well as the final study report. The PI’s job description and curriculum vitae were reviewed.

Information on the receipt, storage, handling, and accountability of investigational products at all stages of the trial was documented. Details related to shipment, delivery, receipt, description, storage (including storage conditions), dispensing, administration, and reconciliation of any remaining pharmaceutical products were verified. Information on the pharmaceutical products included dosage form, strength, batch number, and expiry date. Pharmaceutical products were stored under appropriate conditions in accordance with the specifications provided by the sponsor. …

Randomly selected CRFs from the study were reviewed using a risk-based approach. Verification focused on completeness, consistency, and accuracy of the recorded data against source documents, including laboratory reports and ECGs. Particular attention was given to critical data points, such as dosing times, inclusion/exclusion criteria, and safety- related information. Cross-checks were performed to ensure traceability and alignment with the trial protocol and applicable SOPs. The data to be collected for each volunteer were predefined in the study protocol. …

A database maintained by JFDA (Participants in Clinical Trials Database) was used to prevent cross-participation and to ensure that a minimum interval of 80 days elapsed between a volunteer’s participation in one study and the next. Access to the database was password-protected and restricted to authorized study staff to ensure the confidentiality of volunteer information. Procedures for recruiting volunteers were defined in the applicable SOP and included a description of the methods used by the CRO. …

The study was planned, organized, conducted, and monitored to ensure an acceptable safety profile, including for the volunteers. A medical doctor was responsible for clinical decision-making in the event of adverse events and for notifying the relevant health authorities, the sponsor, and, where applicable, the ethics committee, particularly in cases of serious adverse events. First-aid equipment and appropriate emergency medication were available in the ICU and were ready for immediate use at the study site. …

Following method development, an analytical plan was prepared as the basis for method validation. A stable isotope-labelled internal standard was consistently used in the MS methods, and lithium heparin was used as the anticoagulant. During method validation (Validation of a High-Performance Liquid Chromatography– Tandem Mass Spectrometric Method for Determination of Pyrimethamine and Sulfadoxine in Lithium Heparinized Human Plasma), conducted in accordance with SOP for bioanalytical method validation, an analytical run was performed to evaluate batch performance with 153 samples comprising ca …

The specifications of the samples (blood plasma), including sampling method, volume, and number of samples, were defined in the clinical trial protocol and in the information provided to the volunteers. Sample collection, preparation, transport/shipping, and storage were performed in accordance with SOP for biological sample collection and handling. Actual sampling times and any deviations from the predefined sampling schedule were recorded. These deviations were taken into account when calculating pharmacokinetic parameters. …

Integration settings were scientifically justified and appropriate. The smoothing factor was maintained at a level that did not obscure potential interferences or alter peak geometry, i.e., less than 3. The algorithms and chromatographic parameters used for the study methods were verified, and the relevant SOP was reviewed. Acceptance and exclusion criteria for calibration curve standards and QC samples, as well as batch acceptance criteria, were defined in the applicable SOPs. …

A tour of the facility was conducted on Day 4 to assess its suitability in terms of layout and safety. The general principles of Good Laboratory Practice were followed during the bioanalytical phase of BE studies, supported by an established and appropriate QA system. Deep freezers for sample storage and refrigerators for reference standards were adequately qualified, calibrated, and maintained. An alarm system linked to digital thermometers was in place to trigger SMS and call notifications to responsible personnel in case of excursions. This system was reviewed. …

A detailed presentation was provided by the statisticians, covering the Pharmacometrics Unit (PMU) workflow, including randomization procedures, data management, pharmacokinetic and statistical analysis processes, and report generation. The presentation also addressed the use of validated software systems, quality control measures, and compliance with applicable SOPs, and included examples and clarifications in response to questions raised during the inspection. …

The process of study report preparation was verified during the inspection. Procedures were in place to ensure the quality and integrity of the study report. The study report included a section on the bioanalytical component of the trial, comprising a description of the bioanalytical method used and the corresponding method validation report. The Principal Investigator approved the clinical study report prior to data transfer to the statistical unit. Bioanalytical reports were also reviewed and approved by the responsible personnel and management. …

Based on the areas inspected, the people met and the documents reviewed, and considering the findings of the inspection, including the observations listed in the Inspection Report, Chongqing Huapont Shengchem Pharmaceutical Co., Ltd, Changshou Site, located at No.6, Huanan 1st Road, Yanjia Avenue, Changshou District, Chongqing, 401221, P.R. China was considered to be operating at an acceptable level of compliance with WHO GMP Guidelines. All the non-compliances observed during the inspection that were listed in the full report as well as those reflected in the WHOPIR, were addressed by the manufacturer, to a satisfactory level, prior to the publication of the WHOPIR. This WHOPIR will remain valid for three years, provided that the outcome of any inspection conducted during this period is positive.

Quality Management system The documented system for quality assurance was established, with procedures covering key quality elements in place. The Quality Department was divided into QA and QC and was separate from the Production Department. Operations were specified in written form, and critical GMP requirements were essentially being met. An authorized person for the release of APIs was designated. Annual Product Quality Review The preparation of the APQRs was governed by the SOP “Annual Product Quality Review”. …

An organization charts were available. The Changshou site has 207 employees at the time of inspection. The Quality department operated independently from Production department. The reporting lines and accountability were defined. The key personnel of the various departments had pharmaceutical qualifications and were experienced in pharmaceutical manufacturing. Job descriptions Staff members had defined roles and responsibilities, that were documented in job descriptions. The job descriptions of key personnel responsible for qulity and production were checked. …

In general the facilities were located, designed and constructed to facilitate cleaning, maintenance and operations as appropriate to the type and stage of manufacture. Adequate space was provided for the orderly placement of equipment and materials. Manufacturing areas were of a good standard and suitable for the activities conducted therein. The classified areas were monitored for temperature, relative humidity and pressure differentials. …

Design and construction Generally, equipment was of appropriate design and adequate size and suitably located for its intended use, cleaning, sanitisation and maintenance. Equipment and permanently installed processing lines used during the production of an intermediate or API were appropriately identified. Equipment maintenance and cleaning Schedules and procedures were established for the preventive maintenance of equipment. The year 2026 annual Maintenance Program of the 06 workshop was available. …

Documentation system The SOP “Management of numbering of Documents” was checked. Documents related to the manufacture of intermediates or APIs were prepared, reviewed, approved, and distributed according to respective SOPs. GMP documents were stored under the responsibility of the Quality Assurance (QA) department, with appropriate access restrictions in place. Documents were retained for defined periods following the SOP “Management of documentation” and the SOP “Management of Archives”. Batch numbering system The Product batch numbering system and code management were checked. …

Material management system Materials were managed by a hybrid system, both manually and in a computerised system. Materials were procured in accordance with agreed specifications from approved suppliers. Incoming materials were checked upon receipt, assigned with the approved vendor list, and stored in quarantine until they were approved after sampling and testing. Supplier management The SOP “Supplier management procedure” was checked. A vendor audit was performed following the requirements of SOP “Supplier quality audit management procedure”. …

General The production workshops were not dedicated to Linezolid manufacturing. Linezolid API production in the chemical and clean area was in operation at the time of inspection. The relevant blocks were inspected. Raw materials were dispensed using appropriately accurate devices. The BMR of Linezolid in operation was checked and considered to be acceptable. Different quality grades of Linezolid API were produced with the same manufacturing process for different markets/customers. A computerised system was used for process formulation and parameter control. …

Packaging and labelling were not in operation in the clean area during the WHO inspection. The BPRs of Linezolid batches were reviewed and discussed.

Warehousing procedures Adequate facilities were available for the storage of materials under appropriate conditions. Records of these conditions were maintained. Distribution procedures APIs were released for distribution to third parties only after approval by the QP or their delegates. WHO grade Linezolid API batches had not been distributed for marketing.

The QC Laboratories The QC department was divided into the instrumental analysis group and the physicochemical testing group. The microbiology testing at the site was restricted to environmental monitoring and water samples. The samples for product-related microbiology testing were sent to the QC department at the another site of the company. …

VMP The approved VMP for 2026 was available and reviewed. The company qualification and validation policy and programme were defined and documented. The annual VMP was generated, including the schedule for the current year and monitoring its completion date and report. Process Validation The SOP “Production department process validation management procedure” was reviewed. According to the validation master plan and the validation policy, the process validation followed the lifecycle-based approach, including process design, process qualification and continued process verification. …

The SOP “Change Management” was available. Changes were categorized as major, moderate or minor based on impact. Changes related to the WHO Linezolid API were checked during the inspection.

Rejection The rejected products of starting materials, packaging material, intermediates and APIs were handled following SOP “Non-compliance material management”. Rejected intermediates and final products could be reprocessed after approval by the quality head following SOP “Production department handling procedure of non- compliance materials”. The rejection registers were maintained. Reprocessing and reworking According to the SMF, the rework was not allowed. …

Complaints Complaints were classified into two categories: quality and non-quality complaints. Quality-related complaints were recorded, investigated and managed by QA following written procedures. Records of complaints were retained in a paper logbook. An investigation report was required to be sent to the customer when the investigation was finished and the complaint was closed within defined timelines. The quality complaint recorded was checked and discussed. Recalls The common product recall and return procedure was available. …

Production operations were not contracted out for the product related to the WHO prequalification programme. Routine tests of Linezolid were not contracted out, except for the microbiological test thath was performed in the QC laboratory at the another site of the company.

Based on the areas inspected, the people met and the documents reviewed, and considering the findings of the inspection, including the observations listed in the Inspection Report xxx, located at MSN Laboratories Private Limited, located at Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), Sangareddy District, Telangana, Pincode: 502 329; India, was considered to be operating at an acceptable level of compliance with WHO good manufacturing practices for active pharmaceutical ingredients guidelines. The deficiencies observed during the inspection, as listed in the full report, were addressed by the manufacturing site to a satisfactory level before the publication of the WHOPIR. This WHOPIR will remain valid for 3 years, provided that the outcome of any inspection conducted during this period is positive

A detailed presentation of MSN Laboratories Private Limited was provided, outlining its establishment in 2003 and its subsequent expansion into a multi-unit pharmaceutical group with facilities across India. The company specialized in the manufacture of APIs and formulations, supported by dedicated R&D, QC, and regulatory functions. Its operations were governed by established quality management systems aligned with international standards, including WHO GMP, US FDA, and EU GMP. …

Personnel qualification An adequate number of personnel, qualified by appropriate education, training, and/or experience, were available to perform and supervise the manufacture of intermediates and APIs. The responsibilities of personnel engaged in the manufacture of intermediates and APIs were defined in their respective job descriptions, which were reviewed on a sampling basis. Training was regularly conducted by qualified individuals and covered, at a minimum, the specific operations performed by the employee. …

Design and construction Buildings and facilities used in the manufacture of intermediates and APIs were generally located, designed, and constructed to facilitate cleaning, maintenance, and operations appropriate to the type and stage of manufacture. Facilities were designed to minimize the risk of contamination. In areas classified as ISO 8, facilities were also designed and monitored to limit exposure to objectionable microbiological contaminants, as appropriate. …

Design and construction Equipment used in the manufacture of intermediates and APIs was of appropriate design, adequate size, and suitably located to facilitate its intended use, cleaning, sanitization (where appropriate), and maintenance. Equipment was constructed so that surfaces in contact with raw materials, intermediates, or APIs did not adversely affect product quality beyond established specifications. Production equipment was inspected during the inspection to verify that it was operated within its qualified operating ranges and conditions. …

Original documents were prepared on A4-size white paper and, following approval, were retained by QA. Controlled copies were issued to user departments as photocopies of the original, with “QA CONTROLLED COPY” stamped on all pages. Document changes were managed through the change control system and identified by version number. Superseded documents were retrieved and destroyed, except for executed documents. Original copies were retrieved and stamped as “OBSOLETE COPY” on all pages. Document control activities were performed in accordance with the applicable SOP. …

The warehouse was designed to ensure a unidirectional flow of materials, from receipt of starting materials to dispatch of finished products. The warehouse included defined areas for receipt, identification, quarantine, storage, handling, sampling, dispensing, and rejection of materials. Receipt and inspection of raw and packing materials were performed in accordance with the applicable SOPs. Storage and handling of raw and packing materials were carried out in accordance with the respective SOP. A system was established for the evaluation of suppliers of critical materials. …

The production process comprised two stages: intermediate stage (MOP1) and final stage (MOP2). In Stage 1 (MOP1), the key starting material Cytidine was used. Manufacturing activities were performed in Blocks N, P, S, and R. In Stage 2 (MOP2), MOP1 was used as input. Operations were carried out in the V Block intermediate area and Clean Room II. No batches had been manufactured since 2022. The manufacturing process involved controlled reaction steps under a Nitrogen atmosphere in glass- lined reactors, with monitoring of reaction progress by TLC. …

General: An SOP was established, describing the receipt, identification, quarantine, sampling, examination and/or testing, release, and handling of packaging and labelling materials. Packaging and labelling materials conformed to established specifications. Materials not meeting these specifications were rejected to prevent their use in operations for which they were unsuitable. Labels were stored under lock and key in the QC laboratory. …

APIs were released for distribution to third parties only after approval by the Quality Unit. Intermediates were transferred under quarantine to other units under the company’s control when authorized by the Quality Unit. Appropriate controls and documentation were in place. SOP for solvent tanker receipt, inspection, storage, and handling (effective 15 June 2024) was available and was reviewed. Solvents used for MOP1 and MOP2 included methanol, toluene, acetone, methyl tert-butyl ether (in drums), dichloromethane, and IPA. Solvents were delivered by tanker to the tank yard. …

The independent Quality Unit had adequate laboratory facilities. Written procedures, including SOP for sampling and handling, covered sampling, testing, approval or rejection of materials, and storage of laboratory data. Laboratory records were maintained in accordance with established requirements. The analytical raw data issue and checklist for a selected batch were reviewed. The batch was tested on 8 Mar 2022, and the analysis was completed on 22 Mar 2022. …

Validation documentation The Validation Master Plan described the company’s approach and intentions regarding validation activities. Validation was performed for all relevant activities in accordance with the defined Validation Policy and SOP (Master Validation Plan). Revalidation, where required, was performed in accordance with the current version of the Validation Master Plan and the Process Validation SOP. …

A formal change control system was established through the respective SOP to evaluate all changes that could impact the production and control of APIs, as well as related SOPs and computerized systems. The SOP defines the process for identification, documentation, review, and approval of such changes. Selected change control requests were randomly selected and reviewed. Separate register logbooks were maintained for each product. The register for Molnupiravir for the years 2025 and 2026 was available and was reviewed. …

Rejection APIs that did not meet established specifications were identified and placed under quarantine. Reprocessing and reworking SOP for reprocessing and reworking (effective 1 June 2023) was available and was reviewed. The SOP defined requirements for reprocessing and reworking of intermediates and APIs that did not conform to established specifications and was applicable to MOP1 and MOP2. Reprocessing and reworking were clearly defined in the SOP. Where reprocessing was performed, the resulting batch was required to be included in both accelerated and long-term stability studies. …

Complaints SOP for Market Complaint Management (effective 1 June 2023) was available and was reviewed. The SOP defined procedures to ensure that complaints were recorded, investigated, and reviewed within defined timelines to prevent recurrence. Complaints were classified as Critical, Major, or Minor, with definitions provided. Responsibilities of the respective departments and timelines for each stage of complaint handling were defined. Preliminary investigation timelines were established as 7 days for critical complaints and 15 days for major and minor complaints. …

The qualification of contractors, manufacturers of APIs, and other critical material suppliers, as well as the use of external scientific, analytical, or technical services, was defined in the current version of Supplier Qualification. The company utilized external laboratories for activities not available in-house. A list of contractors was available and discussed. Contract manufacturers were evaluated by Corporate QA to ensure GMP compliance for the specific operations performed at the contract sites. …