Self-Inspection and Remote Inspection: How to Improve the Inspection Process and Succeed in Remote Inspection?

In the context of the current COVID-19 health crisis, the regulatory authorities (ANSM, FDA, ANVISA, PMDA,...) are carrying out both on-site inspections and remote documentary inspections. 

 The challenges of regulatory inspections

The objective of an inspection by a regulatory authority is to ensure the compliance of the facilities and to identify deviations from official standards (laws, regulations, GMP guide, MA file, pharmacopoeias in force) and internal standards (establishment file, general and specific procedures), recommendations (ICH, PIC, PIC/S and WHO) and standards of the profession PIC/S, ISO 14644, ASME-BPE, ISPE, ... The deviations identified may be critical, major or minor.

Maintaining a permanent internal audit allows both

• to develop the Quality Management Systems, the GxP fundamentals 
• to be ready at any time to perform and pass an inspection (see GMP - Chapter 9). 

Preparing for such an inspection, including the phases: "BEFORE, DURING AND AFTER", represents an important step for the future of the company.

Inspection Preparation:

An inspection notification (= inspection request) is sent by the entity inspecting the site. It is sent to the Responsible Pharmacist (regulatory inspections), to the Quality Manager or Site Manager. On this occasion, a document request can be made by the inspector himself or by other persons. Failure to respond to the inspection request or to transmit the requested documents prior to the inspection may be considered as a limitation or a desire to delay the inspection according to the guide "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection". 

Upon receipt of the inspection announcement, it is the responsibility of the Quality Department to: 

• Identify the scope of the inspection,
• Inform the management who will relay this information to the staff they supervise,
• Inform all personnel in order to ensure sufficient support before or during the inspection,
• Record the date, time and name of the person who received the list of prior requests and the date when the requested documents will be available,
• Ensure that experts are available throughout the inspection,
• Reserve the rooms for the inspection, front room, back room and advanced back room.
• Organize the reception logistics,
• Searching for information on the inspectors' profiles (field of expertise, questioning of sites already audited by the inspector...)
• Communicate internally on the inspection (inspecting entity, scope of the inspection, nature of the inspection)
• Inform, if necessary, suppliers and/or subcontractors,
• From the scope of the inspection, establish the composition of the teams and define the roles of each one:
• Inspection team (front room) composed of a leader, a scribe, a runner and a co-runner
• Inspection team (back-room) composed of a leader, co-leader, a documentation coordinator and experts by subject or by process
• List of fronters with identification of back-ups
• And prepare the inspectors' visit circuit (Who? What? When? How?) 
• Carry out "pre-inspection" visits of the site to check the consistency of what is written in the procedures and the implementation of good practices in the field, if necessary:
• Correct any discrepancies
• Identify potential risk hot spots within the scope of the inspection and communicate them to the management committee (review of internal audit reports, review of the quality plan and the progress of associated CAPAs, review of deviations, CAPAs and complaints, review of action plans following the last inspections, etc.)

To ensure a successful inspection, it is strongly recommended to implement the 8 steps of good inspection practices below: 

• Team composition (Scope, Auditors/Inspectors, Auditees, .....)
• Share practical information with all personnel (e.g. date/time of arrival of inspectors, agenda, etc.)
• Define the Roles and responsibilities of the FRONT ROOM team
• Define the roles and responsibilities of the BACK ROOM team
• Set up coaching sciences for the staff
• Define a visit and operation organization.

Documentation Preparation:

In some cases, a list of documents to be kept ready on the first day of inspection is sent to site management, typically the documents requested are those listed below:

1. List of general Quality Management System procedures,
2. Evidence of CAPA completion from previous inspections,
3. List of batch returns/recalls,
4. List of Change-Controls related to the inspection,
5. List of deviations,
6. List of OOS with product and environmental impact,
7. List of CAPAs associated with deviations / OOS
8. List of released batches, shipped batches,
9. List of rejected batches with the reason for rejection,
10. List of complaints,
11. List of media fill tests and associated results,
12. Supplier audit plan for year n, follow-up and completion n-1
13. Self-inspection plan year n, followed and realized year n-1, list of qualified auditors,
14. Training plan year n and completed year n-1, ect....

Preparation of the participants (Coaching):

A training module is highly recommended to train all persons likely to meet and/or be interviewed by an inspector (during visits, during interviews). It should be given by a person with a good knowledge and experience of inspections. 

The topics to be covered in this training are 

1. How to behave in an inspection and during an interview to facilitate the process of : 

• Answer only questions within your area of expertise, 
• Never lie,
• Make sure you have understood the inspector's question, have a question rephrased if necessary..., 

1. Inform about the consequences and possible impacts of an inspection
2. Remind yourself of what an inspector can and cannot do
3. Remind them of the expectations of inspectors 

Remind them that no commitment can be made by personnel on their own initiative (do not read, sign or accept a written affidavit presented by the inspector unless expressly authorized by the Site Director or Quality Manager).

Giving yourself the means to succeed in regulatory inspections

We offer support with a Training/Mentoring/Coaching System before, during and after the inspection. 

We also offer Software that is designed to help companies to be always ready to pass an inspection and that allows to evaluate and manage : 

• The QUALITY Management System and the fundamentals of Good Manufacturing Practices (GMP)
• The COMPLIANCE or not with the STANDARDS,
• REGULATORY REQUIREMENTS,
• REFERENTIALS in force,
• And the RISKS according to the above criteria and others specific to Risk Management.

Our digital solution streamlines, facilitates and accelerates the realization of : 

1. Internal and External AUDITS on site or remotely
2. Internal and External EVALUATIONS in the context of :

• a QUALITY approach 
• INSPECTIONS by accredited organizations and/or regulatory bodies (ANSM, FDA, ANVISA etc.) 
• Any process of CERTIFICATION (e.g. GMP Certificate, CE Marking - HAS for Health Establishments etc...)

The OBJECTIVES sought can be : 

1. CURATIVE and/or CORRECTIVE to improve QUALITY, increase RESILIENCE and reduce the level and/or severity of RISKS
2. PREVENTIVE during the development of a new PRODUCT or SERVICE in order to validate the PROCEDURES and DOCUMENTS that will be used for any launch of an INDUSTRIAL PROCESS, a PRODUCT, a SERVICE or an EVENT in order to immediately comply with the STANDARDS - REGULATORY REQUIREMENTS and REFERENTIALS related to the PRODUCT;

The implementation of our digital solutions takes place in 3 STEPS: 

1) Creation of the IDENTITY CARD of the structure to be evaluated in the form of questions (about fifty) allowing to define the CONTEXT in which this structure operates. This step is carried out jointly by the client and our experts. 

2) Constitution of a DOCUMENTARY SET made up of internal and external documents which will be confronted with the STANDARDS - REGULATORY REQUIREMENTS and REFERENTIALS to which the activity defined in the Identity Card is subjected. This work is the sole responsibility of the client. 

3) Production of SUMMARY REPORTS according to the level of service chosen, i.e:

• ANALYST will display all NON-CONFORMITIES in each of the analyzed documents,
• MANAGER will propose CORRECTIVE MEASURES to improve QUALITY, reduce risks and increase the RESILIENCE of the structure. These measures can be tested before any implementation and thus allow arbitrations,
• EXPERT will highlight the COHERENCES or NON-COHERENCES that may exist in the documents used in 2 or more PRODUCTION UNITS, 2 SUBSIDIARIES and/or several HEALTH FACILITIES belonging for example to the same Group.

Benefits of the approach:

Our software is designed and developed by an R&D Team thanks to a very innovative methodology and technology developed from a powerful, fast and proven computer modeling whose main objectives are: 

1. Improvement of the Quality Management System,
2. Risk Assessment, Control and Management,
3. Strengthening the Resilience of a production unit and/or a public or private structure in its entirety (Group - Company - Organization) belonging in particular to sectors of economic activity subject to strong regulatory constraints.

One of our flagship software packages can be used to perform DOCUMENTARY ANALYSES remotely or on site by Risk Managers, Auditors, accredited independent inspectors, specialized firms and certifiers for most of the international STANDARDS - REGULATORY REQUIREMENTS and REFERENTIALS in force.

Our digital solution can analyze 5,000 documents in computerized format in only 3 hours and produce one or more REPORTS. All alphabetical languages and systems such as Japanese, Korean or Chinese are accepted.

In conclusion

Passing the inspection proves that your company is GxP compliant and that your Quality Management System ensures the production of pure, effective and safe products for the patient.

This success allows the company to continue to :

• Increase the level of confidence with regulatory agencies and patients,
• to keep its A.M.M. file up to date
• to renew its GMP certificate,
• renew its Authorization to Open a Facility (AOE) file,
• and to avoid an injunction.