It is considered that necessary manufacturing facilities (buildings, machines, utilities, laboratory facilities, etc.) are already ensured when the company is preparing for regulatory inspection. For highly regulated authorities (e.g. US FDA, MHRA, ANVISA), the company should start inspection preparation before 6-12 months of inspection. For other or local authorities, the company should start inspection preparation as per their convenience (e.g. before 1-3 months).<\/p>\n\n\n\n
Regulatory Inspection Management can be performed in four phases:<\/p>\n\n\n\n
Phase 1: Continuous Compliance<\/p>\n\n\n\n
Phase 2: Pre-Inspection Preparation<\/p>\n\n\n\n
Phase 3: Host Inspection<\/p>\n\n\n\n
Phase 4: Post-Inspection Activities<\/p>\n\n\n\n In this phase, it is the responsibility of relevant stakeholders to proactively identify, assess and mitigate any potential quality or compliance-related issues and secure compliance. This is a continuous process to ensure inspection readiness. However, formal preparation targeting any specific regulatory inspection can be started at any suitable time as per the need of the site. The approach taken to assure continuous compliance involves various aspects utilized to identify risks or potential issues, which may impact the compliant operations within the site. These continuous compliance aspects may include (as applicable) but are not limited to:<\/p>\n\n\n\n Hot topics are any current areas of focus or intensified scrutiny for inspectorates within a system or process. Regulatory trends can be identified from available recent inspection observations (e.g., 483 reports from the FDA website). Proactively assessing these areas for the level of compliance and addressing any gaps within the system or process will help to ensure a positive presentation to regulatory authorities when required.<\/p>\n\n\n\n The QA function should continuously review regulatory trends and distribute updates to internal stakeholders to assess and mitigate the risk. <\/p>\n\n\n\n Following are the \u2018Hot Topic\u2019 or \u2018Regulatory Trend\u2019 as examples:<\/p>\n\n\n\n For any \u2018Hot Topic\u2019 or Inspection Trend, storyboards or presentations and\/or risk assessment\/ QMS report may be required to support the inspection and\/or defend a compliance issue. These should be prepared and maintained to ensure availability in the event of an inspection with that area in scope.<\/p>\n\n\n\n Gaps within systems and processes must be proactively managed in accordance with relevant procedures. Gaps may be identified from a number of different sources, all of which must be considered as part of the assessment (where applicable). These sources include:<\/p>\n\n\n\n Addressing compliance gaps ensures that the site has a key awareness of potential vulnerabilities. This enables the relevant stakeholders to dedicate resources to address any gaps in advance of the inspection. <\/p>\n\n\n\n Identified gaps should be addressed, based on the level of risk and impact on the product, patient, company, and success of the inspection. In cases where full mitigation is not possible prior to the inspection, a plan must be developed to address how the topic will be presented during the inspection.<\/p>\n\n\n\n A compliance check must be performed against the dossier or documents submitted to the regulatory authority. Product formula, manufacturing process, specification, testing method, etc. must comply with the dossier or documents submitted to the regulatory authority. If any gap is identified, appropriate action should be defined through the applicable QMS tool (e.g. deviation, risk assessment).<\/p>\n\n\n\n The aim of Quality Metrics oversight is to have continuous awareness of potential quality or compliance deficiencies. Quality Metrics should be established and monitored regularly to ensure that potential issues are identified, addressed, and escalated, as necessary.<\/p>\n\n\n\n Self-inspection and\/or Quality oversight should be performed before the regulatory inspection to assess the readiness. Necessary remediation should be performed to address the findings.<\/p>\n\n\n\n This phase begins upon realization (previously announced or unannounced) of an inspection. <\/p>\n\n\n\n First, site management should nominate the \u2018Inspection Lead\u2019 to lead the inspection management. Usually, Inspection Lead is the Head of Quality Assurance or the Manager of Quality Assurance\/ Quality Compliance. Also, any qualified person capable to lead and who has knowledge & experience in inspection management can be an Inspection Lead. Then Inspection Lead should form an \u2018Inspection Preparation Team\u2019 including representatives of all applicable departments\/ functions. A minimum of two representatives should be members from each department- preferably the first representative is the manager or lead of the relevant department and the second representative is as the backup representative from the relevant department who can take care of activities on behalf of the manager when required. The inspection Preparation Team will be responsible to execute\/follow-up preparation activities and communicate & coordinate with Intra\/inter-department as applicable. <\/p>\n\n\n\n The Inspection Team should select the personnel for the front and back room. If possible, as per site resources, the following role should be assigned:<\/p>\n\n\n\n Personnel may assume more than one role, as needed during an inspection. <\/p>\n\n\n\n The inspection Preparation Team should finalize the following:<\/p>\n\n\n\n This phase of the process begins upon the arrival of the inspector.<\/p>\n\n\n\n When an inspector announces themselves, the reception\/security staff must notify the designated single point of contact\/contact list of the inspector\u2019s arrival.<\/p>\n\n\n\n The inspector must be registered as a visitor and provided with the relevant identification in accordance with the procedure.<\/p>\n\n\n\n For unannounced inspections, the single point of contact will liaise with the inspector to determine the focus and scope of the intended inspection, and gather the relevant QA and business functions to host the inspection.<\/p>\n\n\n\n For announced inspections, the assigned escort from the Inspection Team is dispatched to escort the inspectors to the designated front room for the inspection. Then following inspection activities should be performed as agreed with the inspectors:<\/p>\n\n\n\n Before the receipt of the final inspection report, potential responses to the provisional observations received during the inspection Exit Meeting should be discussed, including possible CAPA plans. <\/p>\n\n\n\n QA and the involved functions jointly determine a strategy for responding to any inspection observations. <\/p>\n\n\n\n Once the proposal for the response to Health Authority is agreed upon by all required parties, the response is sent to the Health Authority by the Inspection Lead, or other designees (i.e., QA representative, Regulatory Affairs, etc.).<\/p>\n\n\n\n If the Health Authority provides a response or inquiry around proposed CAPAs, this must be carefully reviewed and all concerns from the Health Authority addressed in a follow-up response.<\/p>\n\n\n\n If the Health Authority accepts the response\/ proposed CAPA, the CAPA must be tracked through the QMS system. As actions are implemented, the CAPA and evidence must undergo a quality review to ensure the implementation of the CAPA is adequate and effective.<\/p>\n\n\n\nPhase 1: Continuous Compliance<\/strong><\/td> Proactive identification, assessment, and mitigation of any potential quality or compliance-related issues and secure compliance.
Such as: \u2018Hot Topics\u2019 or Regulatory Trends assessment, Gap assessment against guidelines, Regulatory Filing Compliance, Monitoring & Evaluation of Quality Metrics, Readiness assessment through self-inspection\/ Quality Oversight, etc.<\/td><\/tr>Phase 2: Pre-Inspection Preparation<\/strong><\/td> This phase will start when the company will be aware of the Inspection date or tentative date. The Inspection Team will ensure: the closing of open actions from phase 1, focused preparation considering inspection scope, logistics, SME selection, opening presentation, infrastructure, and processes to support the inspection including front room & back room, mock inspection, etc. Necessary training on inspection management including inspection behavior is to conduct in this phase.<\/td><\/tr> Phase 3: Host Inspection<\/strong><\/td> This phase of the process begins upon the arrival of the inspector. The opening meeting, plant tour, document review, interview by Inspector, system inspection, daily wrap-up, and closing meeting- all of these will be managed by Inspection Team.<\/td><\/tr> Phase 4: Post-Inspection Activities<\/strong><\/td> Response or CAPA to the observations.
CAPA Implementation and Follow-up.
CAPA Implementation report to HA.<\/td><\/tr><\/tbody><\/table>![\"Process](\"https:\/\/ijlsbd.com\/qs-blog\/wp-content\/uploads\/2022\/09\/Process-Flow.png\")
Phase 1: Continuous Compliance<\/strong><\/h2>\n\n\n\n
I. \u2018Hot Topics\u2019 or Regulatory Trend Assessment<\/strong><\/h3>\n\n\n\n
II. Gap Assessment<\/strong><\/h3>\n\n\n\n
III. Regulatory Filing Compliance<\/strong><\/h3>\n\n\n\n
IV. Monitoring and evaluation of Quality Metrics<\/strong><\/h3>\n\n\n\n
V. Readiness assessment through self-inspection\/ Quality Oversight<\/strong><\/h3>\n\n\n\n
Phase 2: Pre-Inspection Preparation<\/strong><\/h2>\n\n\n\n
Front Room Role<\/strong><\/td> Responsibility<\/strong><\/td><\/tr> Lead Host<\/td> Acts as the lead host and sits beside the lead inspector<\/td><\/tr> Second Host<\/td> Acts as the second host and sits beside the second inspector (More hosts should be assigned if there are more inspectors)<\/td><\/tr> Scribe<\/td> Documents the proceedings of the inspection<\/td><\/tr><\/tbody><\/table> Back Room Role<\/strong><\/td> Responsibility<\/strong><\/td><\/tr> Back Room Lead<\/td> Manages the Back Room, Contacts Subject Matter Experts<\/td><\/tr> Document Quality Control (QC) Reviewers<\/td> Responsible for the review of documentation prior to it being released to the Inspectors<\/td><\/tr> Document Tracker<\/td> Manages Document Request Log<\/td><\/tr> Advisor\/ Mock Interviewer<\/td> Releases documents as inspection ready.
Prepare\/ De-brief Inspection Interviewees for their interviews with the inspectors <\/td><\/tr>Runners<\/td> Transfer documents\/requests between the Front and Back Rooms (May not be required if online communication such as Microsoft Teams\/ Skype\/WhatsApp is used.)<\/td><\/tr> Subject Matter Experts<\/td> To provide in-depth knowledge on inspection topics to the inspector.<\/td><\/tr> Touring team<\/td> Assembled personnel to tour with the inspector(s) during the site visit<\/td><\/tr><\/tbody><\/table> ![\"Regulatory](\"https:\/\/ijlsbd.com\/qs-blog\/wp-content\/uploads\/2022\/09\/pexels-christina-morillo-1181611-1024x684.jpg\")
<\/figure>\n\n\n\nPhase 3: Host Inspection<\/strong><\/h2>\n\n\n\n
Phase 4: Post-Inspection Activities<\/strong><\/h2>\n\n\n\n