VIRTUAL INSPECTION
PURPOSE:
To lay down the procedure for establishing a comprehensive system of virtual inspection in order to determine the effectiveness of the systems, system compliance and to identify the opportunities for continual improvement as per current regulatory requirements.
SCOPE:
This SOP is applicable for conducting virtual inspection of all Manufacturing/Analytical sites of Vendors, Contract Testing Laboratories, and Contract Manufacturing Organization & Service providers Facility.
RESPONSIBILITY:
For Corporate Quality Inspection for Manufacturing/Analytical Sites.
Corporate Quality and Compliance:
To prepare the virtual Inspection agenda & prerequisite document list.
To share the inspection agenda & prerequisite document list with the auditee site well before the inspection start date.
To review the compliance status, adequacy and effectiveness of each of the quality system.
Site Quality Assurance and cross functional teams:
To provide the prerequisite documents scan copies/ videos/ photographs as per the prerequisite document list.
To participate and assist inspectors during the performance of virtual Inspections.
To arrange live walk through of the facility (wherever applicable) with help of suitable audio-visual devices (e.g. video camera etc.).
To prepare and review the response(s) to all observations issued
To ensure proper corrective and preventive action against Inspection observations.
Information Technology Team:
To make necessary arrangement for uninterrupted internet connectivity and networking service to support the information and communication technology software (e.g. Microsoft Team, Zoom or Adobe Connect) used for virtual Inspection.
To make necessary arrangement and provide required data access (in the applicable network digital folders) to the inspectors.
To provide required remote access to the inspectors in GxP software’s (if applicable).
To make necessary arrangement of uninterrupted Wi-Fi connectivity for live facility walkthrough (if applicable).
Site Quality Assurance Head:
To approve the response(s) for all observations issued.
To ensure effective implementation of corrective and preventive actions for the observations identified during the inspection.
For Vendor/ Contact Testing Laboratory/ Contract Manufacturing Organization/ Service Provider facility inspection:
(In this SOP, Vendor/ Contact Testing Laboratory/ Contract Manufacturing Organization/ Service Provider shall be collaboratively mentioned as external auditee).
Purchase department/ Business Development:
To coordinate between Company and the external auditee for an inspection to conduct the vendor Inspection.
Corporate Quality and Compliance:
To prepare the virtual Inspection agenda & prerequisite document list.
To share the Inspection agenda & prerequisite document list with the external auditee site well before the Inspection start date.
To conduct the virtual Inspection, review compliance report and follow up for implementation of corrective and preventive actions.
To approve/ reject the external auditee site based on the inspection outcome and audit response.
To communicate external auditee team’s responsibility.
Vendor/ Contract Testing Laboratory/ Contract Testing Laboratories/Service Providers:
To provide the prerequisite documents scan copies/ videos/ photographs as per the prerequisite document list.
To participate and assist inspectors during the performance of virtual inspections.
To arrange live walk through of the facility (wherever applicable) with help of suitable audio-visual devices (e.g. video camera).
To make necessary arrangement for uninterrupted internet connectivity and networking service to support the information and communication technology software (e.g. Microsoft Team) used for virtual Inspection.
To make necessary arrangement to provide required data access (in the applicable network data folders) to the inspectors.
To provide required remote access to the inspectors in GxP software’s (if applicable).
DEFINITIONS:
Virtual Inspection:
Virtual Inspections are paperless, electronic Inspections that are conducted without face to face interaction between inspecting agency and auditee site. Virtual Inspection is conducted by using suitable information and communication technology (ICT), when the in-person Inspection or physical Inspection of the manufacturing site or laboratory is not possible due to travel restriction or any other reason.
Fully Virtual Inspection:
The Inspection is performed entirely using remote techniques – from planning to execution to follow-up control.
Partly Virtual Inspection:
The inspection is partially performed using remote techniques, where the inspectors are physically present in the inspection site for part times and rest of the inspection are completed through remote techniques.
Alternatively, few of the inspectors can be physically present in the inspection site for in person inspection whereas rest of the inspector performs the virtual inspection through remote techniques.
PROCEDURE:
Virtual inspection shall be conducted only when the onsite inspection of the auditee site is not possible or feasible due to travel restriction or any other reason.
The detailed process of Inspection scheduling, physical Inspection execution, Inspection reporting & follow-up are mentioned in the following global SOPs.
- SOP of Vendor Audit Management.
- SOP of Qualification of Contract Testing Laboratory.
- SOP of Corporate Quality Audit.
- SOP of Contract Manufacturing Organization Inspection.
For virtual inspection also, respective SOP & documentation procedure to be followed for inspection scheduling, inspection methodology, inspection reporting and follow-up.
Before planning of virtual Inspection of any site, inspecting team should evaluate the virtual inspection feasibility based on below mentioned parameters.
Availability of the suitable ICT in both the side: Suitable ICT should be chosen considering that it should allow access to relevant documented information including software, databases, records etc. It should also make the authentication/identification of interviewed people preferably with image.
If observation of facilities, processes, activities etc. are relevant to achieve inspection objectives, it should possible to access them by video. More than one ICT can also be used wherever required.
Availability of Internet Connection: There should be a stable internet connection with good online connection quality. If a live facility walkthrough is required in the Inspection, the route should be checked with devices that will be used to livestream the Inspection prior to Inspection day to ensure Wi-Fi dead spots don’t threaten the process.
People of the Organization: Relevant peoples of the auditee site should be accessible for remote discussion (e.g. video conferencing). People must be adequately trained on the software & hardware intended to be used for remote discussion.
Digital Quality of Document: The digital quality of the data to be reviewed should also be considered for inspection feasibility. This is more relevant when the organization, retains information on paper that needs to be scanned as Optical character recognition (OCR) files (when possible) for remote review.
All documents requested during the virtual inspection to be provided in electronic format or accessible by screen sharing during a live interaction so that the documents can be assessed efficiently. In case of encrypted and password-protected files, proper access must be provided to the inspectors.
Complexity of the Organization and Inspection Type: In case of complex organizations, processes, or products and services and where the objectives of the inspection type require full assessment of operations and quality system and wider sampling (e.g. initial assessment or reassessment) a careful analysis should be performed for feasibility of virtual Inspections.
Virtual inspection methodology: Virtual Inspection should be executed through following steps:
- i) Pre-Inspection Activities:
- Inspection agenda preparation and sharing
- List of pre-requisite documents preparation and sharing
- Review of Previous Inspection Report (if applicable)
- ii) Inspection Performance:
- Opening Meeting
- Review of pre-requisite documents and on demand documents
- Virtual tour of the Facility /Laboratory (wherever applicable)
- Review of online documents through GxP software (where ever applicable).
- Virtual discussion of the concerned personnel.
iii)Post Inspection Activities:
- Closing Meeting
- Inspection report preparation and sharing.
- Compliance review and follow up
Pre-Inspection Activities:
Inspection Agenda:
Inspection agenda shall be prepared for each virtual inspection planned.
Inspection agenda shall be prepared by the inspector’s team as per the format mentioned in the respective SOP. In case specific audit agenda format is not available in the respective SOP, then audit agenda can be prepared.
A virtual Inspection agenda must contain the below mentioned documents (but not limited to).
- i) Inspection Date
- ii) Inspection Scope
iii) Inspectors Name
- iv) Inspection Language
- v) Inspection Methodology
- vi) ICT Details
vii) Document sharing methodology
viii) Date wise Inspection Planning (Tentative)
- ix) GxP software guest login details (Wherever Applicable).
Inspection agenda should be shared with the auditee site team well before the scheduled Inspection date along with the pre-requisite document list and the inspection questionnaire (wherever applicable).
Prerequisite Document List:
This document should contain a specific and comprehensive list of documents which the inspector wants to review during the Inspection.
In addition to the pre-requisite documents list, a set of relevant questions can also be sent as a prerequisite if required by the respective SOP.
Review of Previous Inspection Report:
In case of repeat/ periodic Inspection, past Inspection reports should be reviewed and whenever required relevant compliance documents/ evidences should be requested.
Inspection Performance:
Inspection shall be performed as per the details mentioned in the respective SOPs. Following are the steps to be followed during virtual Inspection.
Opening Meeting:
Inspection shall be initiated on the scheduled date by holding a virtual opening meeting between the inspector and the auditee site’s team. During the pre-Inspection meeting following points need to be discussed (but not limited to):
- Inspection Objective & Scope
- Inspectors Team Introduction
- Site personnel who will be acting as inspection guides (Auditee/Subject Matter Experts).
- Inspection Methodology & Schedule
- Online data review timing through GxP software (where applicable).
- Tentative Schedule for Personal Interview & Livestreaming walkthrough.
Site Presentation
Attendance of the virtual opening meeting shall be recorded, if recommended in the respective SOP.
Review of pre-requisite documents and on demand documents:
Inspectors shall thoroughly review the shared documents to evaluate the overall compliance with cGMP requirements and internal procedures and specifications.
Depending on the nature or Product /Service, documents review should be focused on the following systems:
- i) Quality System
- ii) Facilities and Equipment instrument system
iii) Material system
- iv) Production system
- v) Packaging and Labelling system
- vi) Laboratory Control system
vii) Any other service specific requirements.
The related documents shall be evaluated to ensure the adequacy of the process involved, compliance to the established procedures and the effectiveness, efficiency of the systems in place.
Whenever required additional documents shall be requested for further evaluation. Document requests can be made via chat, email, phone, or online web conferencing.
If any particular documents cannot be scanned and shared for the Inspector’ review (due to size issue or bounded logbooks), then documents and records can be reviewed via screen sharing method or video conferencing tool can be utilized.
During the inspection, inspector shall ensure the compliance against the corrective and preventive actions taken against the previous inspection (wherever applicable).
During the course of inspection, if it was realized that inspection objectives are not achieved completely through virtual inspection then can be complemented with a later on on-site audit.
Virtual tour of the facility/ Laboratory
For replicating an on-site facility and process walkthrough, wherever possible and allowed by the auditee site, a livestream video tour of the manufacturing facility / laboratory should be performed by the inspector’s team.
If full or partial facility and process reviews are feasible, inspector should ask for a facility map of the inside and outside areas to help plan needs and identify areas where photos, videos, or a streamed walkthrough will be necessary.
The quality of the remote connection (e ,g., connectivity, image quality, cameras used) should be adequate for remote review.
With due permission form the auditee team, wherever required photograph / video clips of the virtual plant round can be saved as an inspection evidence.
If livestreaming is not feasible, pre-recorded videos can also be used for examine facilities and operations.
Review of online documents through GxP software
Where available, online GxP software’s (e.g. Training Management Software, Quality Management Software, Document Management Software, Chromatographic and Non-Chromatographic Quality Control Instrument Specific Software etc.) should be used for review of relevant documents.
If required, guest login for the Inspector of such software’s should be requested in well advance. Alternatively, authorized persons from auditee team can show the data to the Inspector as per their request.
Virtual discussion of the concerned personnel.
The virtual inspection should be conducted using a combination of documentary review and virtual meetings and discussions.
Remote discussion can be conducted much like in-person discussion through secure teleconferencing systems.
Whenever possible, video calls should be used over audio-only calls so Inspector can read non-verbal cues.
With due permission form the auditee team, wherever required, interview can be recorded and saved as an Inspection evidence.
Post Inspection Activities
Closing Meeting, after completion of the Inspection, a post Inspection virtual meeting shall be conducted with the responsible departmental heads or representatives to discuss the overall results of the inspection and to ensure the timely implementation of corrective and preventive action (s) for the observations identified during the Inspection.
Attendance of the virtual closing meeting shall be recorded by suitable means, if recommended by the respective SOP.
Inspection report preparation and sharing.
The observations noted during the Inspection shall be summarized in the Inspection report per format mentioned in the respective SOPs. The Quality Inspection summary report shall contain the following (but not limited to).
- Manufacturing/Analytical site inspected.
- Date of Inspection
- Name(s) of the inspector(s)
Name(s) of the auditees(s)
- Systems covered
- Products covered
- Inspection summary
- Inspection observations along with the category
- References to the observations against the guidelines, regulations and/ or established procedures.
Compliance review and follow up
Inspection summary report including Inspection observations/ deficiencies in the quality system shall be issued to the auditee site within the defined time period.”
Once received the compliance report from the auditee site, inspector’s team should review the report & keep continuous follow up to close the Inspection.
6.0 ABBREVIATIONS:
MOM: Minutes of Meeting
ICT: Information and Communication Technology
REFERENCES:
ISO 9001: Auditing Practices Group Guidance on: Remote Inspections.
Guidance for Industry: Remote interactive evaluations of drug manufacturing and bioresearch monitoring facilities during the COVID-19 public health emergency- FDA.
SOP: Vendor Audit Management
SOP: Qualification of Contract Testing Laboratory
SOP: Corporate Quality Audit
SOP: Contract Manufacturing Organization Inspection
