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2026년 9월 1주차 규제뉴스

Microbial contamination was present in the.

Specifically, On 05/08/2025, a surface sample collected from <Redacted B4> (S/N: <Redacted B4>), an ISO Class 5 used for the production of sterile drug products, yielded 4 cfu/plate, exceeding the action limit of <Redacted B4> cfu/plate. The sample was classified as Out of Compliance (OOC) and the following organisms were identified: Cladosporium spp. (pathogenic), Corynebacterium tuberculostearicum, Staphylococcus saprophyticus L and Fungal Overgrowth. Per email documentation provided by the firm, the <Redacted B4> (S/N; <Redacted B4>) was not used following the OOC result until passing recertification, which occurred approximately <Redacted B4> later. Your firm failed to investigate the cause of the OOC result and implement a corrective action plan as required by your Policy Number 797-2022, entitled, Microbiological Air and Surface Monitoring Program, version 2. Additionally, your firm was unable to demonstrate that the 6R4 was not used for the production of sterile drug products during this period.

Fairlue to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 5 area.

Beta-lactam drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.

Specifically, • The firm has routinely reduced both Beta-lactam and non-Beta-lactam drug products within the same ISO 5 <Redacted B4>. S/N: <Redacted B4> and (S/N: <Redacted B4>). During this time the firm's procedure "Cleaning and Disinfecting Compounding Areas" only require the operator to apply sterile <Redacted B4> to surfaces <Redacted B4> production. For example, the firm produced Piperacillin Tazobactam 4.5g7vial Injection; Sodium Chloride 0.9% Injection Bag Bag 100ml on 05/28/2026. The firm failed to conduct decontamination of the <Redacted B4> then produced Phosphorus 3mmol/Potassium 4.4 Meq/ml Injection; Sodium Chloride 0.9% Injection Bag 250ml. • On 06/09/2026, we observed production within 1SO-5 <Redacted B4>) S/N: <Redacted B4>. We then observed that the technician only applied <Redacted B4> to the <Redacted B4> of the <Redacted B4> and no on other surfaces. The firm's current unofficial clearing procedure allows operators to only apply <Redacted B4> to the <Redacted B4> following the production of any Beta Lactam products.

Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas. Your firm also failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.42(c)(10) and 21 CFR 211.63).

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(d)).

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. Your firm also failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.113(b) and 21 CFR 211.58).

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, SCL Lifesciences Limited, located at Derabassi-Barwala Road, Village Bhagwanpura, District Sahibzada Ajit Singh Nagar, Tehsil Derabassi, Punjab 140 507, India was considered to be operating at an acceptable level of compliance with WHO GMP Guidelines for APIs. 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 3 years, provided that the outcome of any inspection conducted during this period is positive.

SCL Lifesciences Limited has established a quality management system (QMS) to ensure the safety, efficacy, and quality of its manufactured products. The manufacturer has a quality unit independent of production that fulfilled both QA and QC responsibilities. A list of qualified personnel was identified for the release of batches of finished API and saleable intermediates. The QMS was managed manually, whereas logbooks for various QMS elements, such as change controls, deviations, OOT and OOS laboratory incidents, were managed in the ERP. …

Mr. Parveen Goyal is the chairman and managing director of the company, and the department heads of VP Quality, Chief Business Officer, Chief Operating Officer, Chief Scientific Officer, Head of HR & Admin, and Director (his son, Mr. Saurav Goyal) report directly to him. Function # of personnels Production 286 Quality Control 70 Quality Assurance 34 Warehouse 17 Human Resource/Admin 12 Engineering 70 Finance and Accounts 10 Purchase 6 R&D and ARD 72 Regulatory Affairs 5 Information System Development 4 Projects 12 MSTG / Tech. …

The manufacturing site has a total land area of 11 acres. There were 3 intermediate blocks, 9 pharma blocks, 1 pressure vessel block, 1 solvent recovery block, an engineering and warehouse block, a separate QA-QC, an R&D building, and an HR Admin Block. A separate solvent storage facility was also provided. A tank farm area with underground tanks for solvent storage was also available. The site has its own drainage system supported by an ETP (Effluent Treatment Plant). …

During the visit to the synthesis and powder processing areas, it was noted that the manufacturing site was equipped with various reactors, filters, centrifuges, tray dryers, multi-mill, sifter, rotacone dryers, etc. The deficiencies raised from this section have been adequately addressed, and the same will be verified during future PQ inspections.

The documents related to the manufacturing of intermediates and APIs were prepared, reviewed, approved, and distributed in accordance with written standard procedures. A hybrid document management system was followed. In a hybrid system, some documents were kept in hard copy, while others were generated electronically via the ERP application. The deficiencies raised from this section have been adequately addressed, and the same will be verified during future PQ inspections.

The SOP for vendor qualification was discussed. The materials were categorized into key starting materials, reactants, and general materials. The QA team performed the initial assessment before vendor samples were tested. The results were forwarded to R&D for manufacturing trial batches before the supplier was approved. Key starting materials (KSMs) and primary packaging materials were audited on-site once every 3 years, whereas the rest were audited every 5 years. Vendor qualification of Diethyl Carbamoyl Chloride was performed by QA. The manufacturer was based in Gujarat, India.

The inspector visited the manufacturing area, Pharma II, where the WHO prequalified DEC was produced. The manufacturing area was spread over three floors. Dispensed raw materials were transferred to the second floor via elevator/hoist. The second floor housed 4 SS and GLR reactors; the first floor had 3 reactors; and the ground floor had 5 centrifuges, 2 tray dryers, 1 pressure filter, and other equipment. The entrance to Pharma II was shared by staff and visitors, whereas a separate entry was provided for materials. …

The SOP for blending of material (more than one batch) was applied to APIs and intermediates. The definition of blending was provided in the procedure, which described the methodology for performing it. As per the procedure, blending shall be carried out in accordance with the approved BPCR. The procedure stated that OOS batches will not be blended with approved batches. The deficiencies raised from this section have been adequately addressed, and the same will be verified during future PQ inspections.

The solid warehouse was briefly visited, and it was noted that incoming materials were stored there, with controlled access. The materials were quarantined before sampling was performed by the quality control laboratory. The RLAF was used to sample polybags. Three dispensing areas were provided for charcoal, primary packaging materials, and other materials. For routine manufacturing, KSM was sampled as per √n+1. The deficiencies raised from this section have been adequately addressed, and the same will be verified during future PQ inspections.

The inspector visited the QC laboratory, which was equipped with sophisticated instruments such as HPLC, GC, IR Spectrophotometer, UV Spectrophotometer, Polarimeter, Total Organic Carbon Analyzer, Auto-titrator (KF), Analytical Balance, FTIR, Melting Range Apparatus, pH Meter, Malvern Mastersizer, and Conductivity Meter. HPLC & GC instruments were supported by the Empower 3.6.1 server, and all systems were backed up. Out of specifications (OOS) The SOP for handling OOS was reviewed. …

The validation master plan was reviewed. In general, the VMP included most elements of qualification and validation activities. Requalification was carried out every 5 years for all production equipment. For the quality control equipment and instruments, qualification was a one-time activity, whereas preventive maintenance was performed every 6 months and annually. Similarly, a calibration schedule for the QC equipment and instruments was available, with calibrations performed monthly, quarterly, and half-yearly. …

The SOP for change management provided guidance on implementing changes, conducting assessments, performing risk assessments, and categorizing them. The QA was overall responsible for managing changes, including those related to the document control system. The changes were classified into major, moderate, and minor. There were two types of change: permanent and temporary. The change controls were tracked using the ERP system. The tracking of changes was done using the ERP system. …

Reprocessing, reworking, and recovery of finished APIs or intermediates were discussed. Unique numbers were given to reprocessed and reworked batches. For solvent recovery, the procedure is batch- driven. For DEC, although DMF provided a tentative procedure, the manufacturer has not performed any reprocessing. For rework, the manufacturer performed no rework. It was noted that IPA and Acetone were recovered from Stage III and IV, respectively, during the manufacturing of DEC. …

A market complaint was received from a customer regarding the drum’s lid. The investigation included a review of the batch records and concluded that everything was in order on the manufacturer’s end, whereas the logistics provider did not handle the material appropriately. The investigation was further extended using a fish-bone diagram. The SCL decided to replace the container lid to provide better protection. The deficiencies raised from this section have been adequately addressed, and the same will be verified during future PQ inspections.

The manufacturer confirmed that Diethylcarbamazine (citrate) is manufactured on-site, with no part of it produced outside. The manufacturer used a contract laboratory for performing the XRD test. The deficiencies raised from this section have been adequately addressed, and the same will be verified during future PQ inspections.