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MINPROMTORG OF RUSSIA

MINPROMTORG OF RUSSIA. SID & GP. IV ALL-RUSSIA GMP CONFERENCE. Corporate Communication Center. A risk-based approach to the classification of detected non-conf o rmities with GMP requirements. Regulatory trends and case studies. Classification of non-conformities.

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MINPROMTORG OF RUSSIA

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  1. MINPROMTORG OF RUSSIA SID & GP IV ALL-RUSSIA GMP CONFERENCE Corporate Communication Center A risk-based approach to the classification of detected non-conformities with GMP requirements. Regulatory trends and case studies

  2. Classification of non-conformities General partner: Strategic partners: Official partners: Regional partners:

  3. “CLASSIFICATION OF TYPICAL NON-CONFORMITIES IDENTIFIED IN THE PROCESS OF INSPECTION” (Federal State Institution “State Institute of Drugs and Good Practices”) • Is used to classify non-conformities identified during the inspection process. • The procedure allows for an unambiguous approach to assigning the degree of criticality of non-conformities identified as a result of inspections of drug manufacturers. • The assessment of compliance with the principles of Good Manufacturing Practice shall be commensurate with the degree of risk, which takes into account the nature and degree of deviation regarding the category of products evaluated. • When compiling an inspection report, identified deviations are reflected in non-conformities with a certain degree of criticality, while taking into account the degree of risk of possible harm to human health or life. • The assigned degree of risk shall be related to the nature of the non-conformity, the frequency of its occurrence and the criticality of the product. • The classification of the part of non-conformities, which are identified as major in the procedure, can be increased to critical in the manufacture of products with a high degree of risk. General partner: Strategic partners: Official partners: Regional partners:

  4. “CLASSIFICATION OF TYPICAL NON-CONFORMITIES IDENTIFIED IN THE PROCESS OF INSPECTION” (Federal State Institution “State Institute of Drugs and Good Practices”) • High-risk product - a product for which one of the following criteria may apply: • narrow therapeutic range; • sterile product; • biological drug; • complex production process: a process in respect of which minor deviations in the control of parameters can lead to a heterogeneous product or a product that does not meet its specification. • Any product that may cause a health risk even in small concentrations (after cross-contamination). This group includes (but not limited to): beta-lactam antibiotics, certain cytotoxic and biological products. General partner: Strategic partners: Official partners: Regional partners:

  5. “CLASSIFICATION OF TYPICAL NON-CONFORMITIES IDENTIFIED IN THE PROCESS OF INSPECTION” (Federal State Institution “State Institute of Drugs and Good Practices”) • Examples of critical non-conformities: • The fact of falsification or distortion of the results of analytical tests is established. • Missing or improper validation of critical sterilization cycles (sterile products). • Aseptic filling continues even after receiving unsatisfactory test results simulating the filling process with nutrient media. • Aqualified person at a company producing drugs with a critical or high level of risk does not meet the requirements established by law for relevant education and work experience. • Examples of major non-conformities: • Equipment and / or computerized systems that are used during critical stages of production, packaging, labeling, as well as when conducting quality control of starting raw materialsor products, are not qualified. • Cleaning procedures for production equipment are not validated (including related analytical methods). • Inadequate capacity and / or limited production space, which can lead to mix-up. • Stability studies associated with changes in production (in the recipe) or changes in packaging material are not conducted. General partner: Strategic partners: Official partners: Regional partners:

  6. PIC / S Guide to Classification of Non-Conformities with GMP Requirements dated January 1, 2019 • Purpose and intended use of the document - harmonization of classification • GMP non-conformities to ensure uniformity of uniformity of reporting on GMP • non-conformities according to inspection results from various inspectorates. • When categorizing non-conformities, risk management principles depending on the type of product or process being implemented apply. • The guide presents: • classification of non-conformities; • non-conformities classification process flow diagram • examples of classification of non-conformities that can be used in determining classification; • facts that increase / decrease risk. General partner: Strategic partners: Official partners: Regional partners:

  7. PIC / S Guide to Classification of Non-Conformities with GMP Requirements dated January 1, 2019 General partner: Strategic partners: Official partners: Regional partners:

  8. Non-conformity detected General diagram of non-conformity classification process (PIC / S Guide to Classification of Non-Conformities with GMP Requirements dated January 1, 2019) Does the action or process pose a significant risk of obtaining the products described for the patient, or contribute to the accumulation of hazardous components in the animal used to obtain food? Yes Critical non-conformity No Yes Is data falsification or intentional misrepresentation or falsification of products proven or observed? No Carry out a detailed assessment of the classification of non-conformity in accordance with Figure 2 Assess risk reduction or increase factors. Mitigating factors Increasing factors There are no factors that reduce or increase the level of risk. Confirmation of the initial classification Decrease in initial classification Increase in the initial classification Classification of non-conformities Major non-conformity Critical non-conformity Other non-conformity General partner: Strategic partners: Official partners: Regional partners:

  9. PIC / S Guide to Classification of Non-Conformities with GMP Requirements dated January 1, 2019 General partner: Strategic partners: Official partners: Regional partners:

  10. PIC / S Guide to Classification of Non-Conformities with GMP Requirements dated January 1, 2019 • Examples of critical non-conformity: • No sterilization validation (applies to all sterile products). • Inadequate control measures leading to actual (or significant risk) of cross-contamination above the level of maximum permissible exposure in subsequent products. • Falsification or distortion of analytical results or records (applies to all manufacturers). • Failure to guarantee the quality and / or authenticity of raw materials (applies to all manufacturers). • Invalid HVAC systems for sterile products (applies to manufacturers of sterile products) • Examples of major non-conformity: • Insufficient validation of critical processes (may be “Critical” for small dosage / highly toxic drugs; in particular, for sterilization processes for sterile products). • Persons holding senior positions in quality control / production are not sufficiently qualified by education, competencies and experience. • Invalid cleaning procedures for production equipment. • Shortened raw material quality control tests without supplier certification data. • Inappropriate deviation handling system. General partner: Strategic partners: Official partners: Regional partners:

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