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2026년 9월 3주차 규제뉴스

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 (21 CFR 211.42(c)(10)).

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)).

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, Zydus Lifesciences Limited, located at Kundaim Industrial Estate, Plot No.203-213, Kundaim, Goa- 403115, India, was considered to be operating at an acceptable level of compliance with the WHO Good Manufacturing Practices for Finished Pharmaceutical Products guidelines. The deficiencies observed during the inspection, as listed in the full report, were addressed by the Zydus Lifesciences Limited 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

General The Quality Assurance system was designed to ensure that finished pharmaceutical products meet current quality standards, with clearly defined responsibilities for all key personnel. QA and Quality Control functions operated independently, reporting to Head Technical Services and maintaining oversight from Central Quality. Site quality governance was defined through established SOPs. …

The site maintained a GMP-compliant quality management system to ensure that pharmaceutical products were consistently manufactured and controlled in accordance with regulatory requirements and marketing authorizations. The GMP system aimed to minimize manufacturing risks and ensure product quality, safety, and efficacy. Manufacturing processes were clearly defined, validated, and systematically reviewed to confirm compliance with established specifications. …

The sanitation and hygiene practices were maintained in all aspects of medicinal product manufacturing. These practices covered personnel, premises, equipment, production materials, containers, and cleaning agents, in accordance with SOP for Cleaning, Sanitization, Fogging of Area and Handling of Cleaning Aids in the OSD Area. The SOP included a list of approved disinfectants, and the applicable efficacy testing had been performed. The applicable documentation was selected and reviewed.

Validation Master Plan The site had established a Validation Master Plan (VMP) for the manufacturing facilities, including the OSD Plant and a Computer System Validation Master Plan (CSVMP) for the Formulation and Anticancer Plant. The VMP defined the overall validation and qualification strategy for facilities, utilities, equipment, products, processes, computerized systems, and other GMP support activities that could impact product quality. …

Complaints related to potentially defective products were reviewed in accordance with the applicable SOP, effective 19/05/2026, and corrective and preventive actions were implemented as necessary. The Head of QA, supported by appropriately qualified personnel, was responsible for complaint handling and decision-making. The SOP described the actions required for complaint management, including the assessment of the need for product recall. Investigations were conducted to determine whether a product defect existed, and all complaints were documented and reviewed by the Quality Control Unit. …

A system was in place to ensure the prompt and effective recall of products known or suspected to be defective, in accordance with the applicable SOP, effective 02/05/2026. List of recalls, and randomly selected documentation were reviewed and discussed. Mock recalls were required to be performed every two years unless an actual product recall occurred during the preceding two-year period.

The Company had quality control services contracted out. However, no manufacturing or other GMP activities were contracted out. A written contract was established between the contract giver and the contract acceptor, clearly defining the responsibilities of each party, including outsourced activities, communication, and technical arrangements. The contract permitted the contract giver to audit the facilities and activities of the contract acceptor or mutually agreed subcontractors.

Self-inspections were conducted in accordance with the respective SOP, effective 25 February 2026. Routine self-inspections were performed every six months, while additional inspections could be initiated in response to specific events such as product recalls, critical market complaints, critical deviations or non-conformances, review of quality metrics, or regulatory inspections. Inspections were carried out by a qualified audit team operating independently and objectively to verify compliance with GMP requirements. …

The site maintained a defined organizational structure covering Quality Management, Production, Quality Control, Storage, and Distribution activities. Organizational charts detailing key functions, reporting relationships, and responsibilities were available and were discussed during the inspection. The organizational structure, staffing levels, and qualification framework were considered adequate to support the manufacture, testing, storage, and distribution of pharmaceutical products while ensuring compliance with GMP requirements. …

Personnel training management and employee qualification were governed by an SOP, which defined the requirements for identifying, planning, delivering, documenting, and evaluating training activities. The training programme was designed to ensure that employees remained qualified for their assigned responsibilities and that competency was maintained throughout their employment. Training requirements were established through a Training Need Identification (TNI) process. …

SOP for Exit Procedure Involving Primary Garment Change and Personnel Hygiene for OSD-II, effective 25/06/2026, was reviewed. Pictorial instructions for hand washing and sanitization, gowning, and de-gowning were displayed at strategic locations. Personnel underwent medical examinations before and during employment, including periodic eye examinations for employees performing visual inspection activities, in accordance with the applicable SOP effective 25/03/2026. …

A site layout, including an area classification layout, was provided and discussed during the inspection. The inspection scope was limited to OSD Block II, where all current Oral Solid Dosage manufacturing activities were performed. OSD Block I was not included within the inspection scope, as it was no longer operational and had been taken out of service pending maintenance and expansion activities. A layout drawing showing OSD Block I, OSD Block II, and the associated manufacturing and packaging lines was available and reviewed. …

Process Equipment Operation and Qualification The operation of process equipment was governed by operating manuals and activities recorded in a software system. The following operating manuals were discussed: − Operation of Tablet Coating Machine − Operation of Filling Machine Equipment and instruments used for dispensing, manufacturing, packing, testing, and other processes were qualified before operational use. …

Written procedures were available for the receipt, handling, and storage of incoming raw materials under applicable procedures. The automated warehouse was common for raw materials, primary packing materials, secondary packing materials, and finished goods. Incoming consignments were visually examined on receipt. Damaged or improperly labelled goods were segregated and referred to Quality Assurance for further instructions regarding disposal or return. …

Document Management The documentation system was controlled through approved procedures for document creation, review, approval, issue, revision, withdrawal, retention and archiving. The documents were handled in electronic, paper-based, or hybrid form. Current authorized versions of procedures and forms were available at the points of use, and obsolete documents were prevented from unintended use. The reviewed Batch manufacturing and packaging records were noted to be sufficiently detailed to reconstruct operations and demonstrate compliance with approved instructions. …

Production was performed in accordance with approved Batch Manufacturing Records (BMRs), with records completed contemporaneously with the activities performed. Reconciliation was conducted at critical stages of manufacture and upon completion of packaging operations. The Production Department was responsible for the preparation and review of SOPs and master BMRs, manufacture and packaging in accordance with approved batch records and SOPs, maintenance of online documentation, personnel training, performance of in-process controls, batch record review, deviation reporting, and execution of pro …

The site had dedicated physicochemical and microbiology laboratories, a control sample area and a stability area. Quality Assurance and Quality Control functions were independent, and their responsibilities and governance were defined in the site quality governance SOP. The QC laboratory was responsible for sampling and testing of raw materials, packing materials, in- process samples, and finished goods for physical, chemical, and microbiological parameters against approved specifications and test methods. …

– Conclusion – Inspection outcome 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 of Egyptian Drug Authority - Central Administration for Drug Control, located at Elmansoureya Street, Haram, Giza; Egypt was considered to be operating at an acceptable level of compliance with WHO Good Practices for Pharmaceutical Quality Control Laboratories guidelines. The deficiencies observed during the inspection, as listed in the full report, were addressed by the Laboratory 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 detailing the Laboratory history and activities was provided during the opening meeting. 1.1. Structural and general requirements The Laboratory was legally authorized by the Egyptian Drug Authority (EDA) to perform testing and issue certificates of analysis. It was responsible for the validity of all results and activities performed. Senior management ensured the establishment, implementation, and maintenance of an effective quality management system, including a data governance system, by providing appropriate policies, training, and technical infrastructure. …

2.1. Externally provided services and supplies The system used to define, review, and approve requirements for outsourced services or products required by the EDA, including criteria for selection, performance monitoring, evaluation, and re-evaluation of service providers to ensure compliance with requirements, was described in SOP Outsourcing and Technical Evaluation of EDA Provided Products/Services, current version last issued on 23 April 2025. A governmental portal listed all pre-approved service providers that could be used by the laboratory for selection. …

3.1. Personnel Personnel with the required education, training, technical knowledge, and experience for their assigned functions were employed, either permanently or on a contractual basis. Competence requirements for each function were documented, and procedures and criteria for selecting and assessing personnel competence were established in accordance with the QMS. Staff undergoing training were supervised and assessed upon completion, with assessments fully documented. …

4.1. Sampling The laboratory was not responsible for sampling. Samples were collected by authority inspectors from pharmacies, distributors, or manufacturing sites and delivered to the Laboratory at the Agouza site. The Agouza laboratory registered the samples in LIMS as either marketing authorization or post-marketing samples, including relevant details such as specifications and required tests. A unique identification number was assigned to each sample. 4.2. …

A tour of the facility was conducted on the first day. A documented laboratory safety policy, including general and specific safety instructions reflecting identified risks, was available and applied by staff. A designated staff member was responsible for overseeing the policy and ensuring compliance. A waste management system compliant with local legislation was in place to ensure the safe disposal of chemicals, solvents, and other relevant materials. Training on safety-related topics was conducted at defined intervals, as specified in the QMS. …