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New format for GMP inspections: a view from global regulators and manufacturers

The most popular event of the GMP conference - a master class - this year brought together regulators from Russia, Azerbaijan, India, Great Britain, Spain, Croatia, Hungary, Bosnia and Herzegovina, Saudi Arabia, South Africa and Korea at one site. GMP inspectorates from different countries shared their experience of working in special conditions and talked about how remote inspections are regulated, organized and carried out.

The global pandemic has changed not only the way of life of everyone, but also made serious adjustments to the work of regulators. In particular, most countries have introduced the remote format of GMP inspections, the peculiarities of which were discussed at the master class, the partner of which was AKRIKHIN.

New conditions or the usual mode of work, but the most important job of the inspector is not to find violations and punish, but to prevent these violations, to work proactively so that the manufacturer can find and identify everything himself, prevent serious violations and prevent the release of low-quality drugs that can to harm people, says Elena Denisova, Deputy Head of the Russian State GMP Inspectorate, Deputy Director of the Department for Development of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of Russia. Therefore, GMP inspectorates around the world understand the concern of drug manufacturers with new inspection formats. To reduce the level of concern and clarify the specifics of working in the new conditions, 12 countries spoke about their approaches to remote GMP inspections. In principle, the approaches of many regulators to conduct inspections in a situation related to COVID-19 are practically the same.


The last group of inspectors from GILS and NP returned from a business trip on March 16, and it was from this date, without stopping work, that the inspectorate began to inspect drug manufacturers using the document analysis format, and already in May, when Resolution of the Government of the Russian Federation No. 789 was issued, allowing the use of photographic and video materials, online or video demonstration of production sites in the work, the Russian state GMP inspectorate began virtual inspections. As of the date of the GMP conference, the Russian inspectorate in the online format has more than 200 inspections of foreign and foreign drug manufacturers.

The off-site inspection procedure begins with obtaining the consent of a foreign manufacturer to conduct an inspection based on the results of document evaluation. Then comes the planning of the inspection using a risk-based approach, the inspectorate determines the criticality or significance of the inspections individually for each site / product. The Inspectorate sends in advance an inspection plan, which indicates a list of documents that will necessarily be considered during the inspection. But the inspection itself is not limited to examining only the documents specified in such a plan. “During the inspection, additional documents may be requested that are necessary for a deep and comprehensive assessment of the manufacturer for compliance with the requirements of the Good Manufacturing Practice (GMP). Communication during such an inspection is carried out by e-mail and by audio or video communication ", - explained Nadezhda Arkhipova, Deputy Head of the Expertise Department of the Federal State Institution" State Medical Institute and NP "Ministry of Industry and Trade of Russia”.

In the transition from routine on-site inspections to online inspections, it was necessary to make changes to internal procedures, to work out international documents that introduced the main approaches and requirements of regulators to this type of inspection. In this situation, the most important thing is to prepare for the inspection: a sufficiently large number of documents must be examined by the inspector before the inspection itself begins, because a limited amount of time is allotted for the inspection. During the pandemic, GILS and NP faced a situation when the site employees themselves did not have access to documents and even to production.

Remote inspections depend, among other things, on the support of IT-specialists - the possibility of organizing online broadcasting. This raises questions related to the confidentiality of the information received, the ability to use it during an inspection, ”says Natalia Chadova, Head of the Department for Inspection of Medicines Production and Expertise of the FBU“ GILS and NP ”of the Ministry of Industry and Trade of Russia.

How about others?


The Hungarian National Institute of Pharmacy and Nutrition has agreed on measures to mitigate the impact of COVID-19 violations during inspections of manufacturing or other drug-related sites in the EU. In the absence of a centralized / corresponding national marketing authorization, Member States may take advantage of the possibilities provided for in Directive 2001/83 / EC, including resorting to charitable use of the drug or authorization to distribute an unregistered drug in accordance with Article 5 (2).

As in Russia and the EAEU, the validity of GMP certificates for manufacturing / importing sites of APIs and / or finished products is extended until the end of 2021 without the need for further action on the part of the certificate holder. "But at the end of next year, the Hungarian National Institute of Pharmacy and Nutrition will conduct inspections at those sites where inspections were postponed during the pandemic," explained the head of the Hungarian inspectorate, Dr. Ferenc Lucas. During the pandemic, the Hungarian regulator carried out only emergency inspections of new production sites and warehouses, remote inspections were started, but only for companies with a valid GMP certificate.

Bosnia and Herzegovina

On April 15, Bosnia and Herzegovina issued an Instruction for Conducting Inspections in Emergencies, establishing the work of inspectors from home according to certain regulations: the inspector must

• review all documentation provided by a legal entity under the authority of the Agency;

• assess whether a remote inspection can be initiated based on available documentation, risk assessment and your experience, and, if applicable, initiate it;

• request information from the director of the legal entity on activities related to the circulation of medicines or medical devices in accordance with positive standards;

• issue an opinion on the fulfillment of the conditions upon request.

If the inspector deems it necessary to conduct an abbreviated direct (on-site) inspection at the applicant's location, then the following algorithm of actions was recommended before leaving the site:

• request by e-mail documentation that demonstrates the implemented quality system, as well as any other necessary documentation, including certificates required for the conduct of inspections;

• prepare, as soon as possible, a draft protocol based on the provided documentation, so that it is at the site for which the request was sent, as little time as possible;

• Conduct a direct on-site inspection;

• initiate administrative action, if applicable;

• issue an opinion on the fulfillment of the conditions.

"In total, the Agency for Medicines and Medical Devices of Bosnia and Herzegovina conducted 20 remote inspections during the pandemic," said Indira Fazlagic, head of the Inspectorate of the Agency for Medicines and Medical Devices of Bosnia and Herzegovina. At the same time, the inspectorate in its work often faced problems related to translation - not all documents were available even in English.


HALMED also extended the validity of the issued GMP certificates until the end of 2021. At the same time, automatic renewal does not apply to changes in the scope of the GMP certificate (for example, new buildings, new drugs), and in the case when the results of remote assessment do not allow the issuance of a GMP certificate, a pause is made until it becomes possible to conduct site inspection. With regard to foreign manufacturers, HALMED, based on a risk assessment in a pandemic, began to conduct remote inspections to confirm the manufacturer's GMP status. For new production sites, remote inspections are only used by HALMED in exceptional cases. The remote inspection procedure is similar to the procedure of the Russian state GMP inspectorate: an introductory meeting, a review of documentation, a final meeting, following which, in the event of inconsistencies received by the production site in writing, the manufacturer prepares a CAPA plan, after examining which inspectors prepare an inspection report, and in case of a positive decision, the issuance of a GMP certificate.

Since June, on-site inspections have been resumed, but in the conditions of different levels of regional exit from the pandemic, HALMED continues to use remote inspections as well.


The process for conducting remote inspections was developed and consolidated in June - July, when the Guidelines for the conduct of GMP / GDP remote assessments and the Plasma Master File (PMF) and AEMPS SOP were released. The latest document includes a number of important points:

• type of inspection, site and manufactured drugs. GMP compliance;

• planning, preparation and evaluation of remote inspections / remote evaluations: communication system, data integrity and security, video, shared use of quality control systems (high performance liquid chromatography, etc.).

Saudi Arabia

3 main groups of measures aimed at ensuring uninterrupted supply

1. The SFDA regulates the export of medicines, thereby ensuring the presence of the necessary pharmaceutical products

2. SFDA facilitates the import of raw materials and packaging materials for local producers

3. SFDA has improved communication with suppliers and manufacturers of APIs and raw materials.

According to Dr.Mohammad Ali Dakhas, SFDA's Executive Director for Inspection Support, SFDA has focused on inspections of domestic manufacturers, a risk-based approach has been introduced for registering foreign production sites during a pandemic, containing a number of criteria and factors to help determine the level of risk and accept decision on inspection format:

1. Availability of a pharmaceutical product in Saudi Arabia

2. The company is registered in the bodies that are members of PIC / S

3. Type and category of product

4. Type of company: what it produces.

SFDA has requested GMP certification from the local regulator and other international bodies from foreign manufacturing sites, evaluated the manufacturing site dossier (SMF), examined the list of all products that were produced on site and supplied to Saudi Arabia, the last report of the last inspection from the local authority, its assessment Confirming Corrective and Preventive Action (CAPA).

South Korea

Korean GMP regulations are harmonized with GMP PIC / S guidelines.

The Korean Ministry of Food and Drug Safety establishes an inspection plan for a local and overseas manufacturer and conducts inspections of overseas manufacturers to obtain permission to import pharmaceuticals. "At the same time, even before the pandemic in Korea, not only forms of inspection were used directly on the site, but also documentary inspections - the pandemic forced this mechanism to be extended to foreign manufacturers," said Deputy Director of the Pharmaceutical Quality Division of the Pharmaceutical Safety Bureau of the Ministry of Food and Drug Safety of Korea Chong Mienhun.

South Africa

In July 2020, the Guidance for Conducting Good Practice (GxP) Inspections during Emergencies / Disasters, including the COVID-19 pandemic, was released. These guidelines presuppose the conclusion of confidentiality agreements between the parties, as well as declarations of authenticity of documents by the inspected entity.

Remote inspection is defined as a combination of online site engagement and documentary assessment,” explained Daon Puwan, senior inspectorate manager for the South African Medical Products Regulatory Authority (SAHPRA).

Among the tools that SAHPRA uses for remote inspections are Skype, WhatsApp, Zoom, Microsoft Teams, Internet cloud systems for document exchange. SAHPRA can conduct a face-to-face inspection if necessary.

With regard to the inspection procedure, SAHPRA follows 3 stages:

1. Introductory meeting

• Ensuring confidentiality agreements are in place

• Discussion of previous CAPA

• Proposed inspection plan

• Discussion of documents required for drawing up an inspection plan

2. Documentary Inspection / Review

3. Remote inspection

• Connection via a virtual communications platform

• Feedback is provided to the site following the results of Stage 2

• Discussion and provision of additional documents / evidence

• Completion of inspection

New format of GMP inspection: a manufacturer's view

Virtual inspections have a number of limitations and take longer. It is very important to involve employees of local divisions in virtual inspections of foreign companies. At the same time, the enterprise may not be ready for the virtual format. Often, during an online inspection, difficulties arise with simultaneous translation and the level of knowledge of the English language of both site representatives and inspectors. There are a number of difficulties with technical means - in some countries or at enterprises, ZOOM or other means of communication are not allowed by security standards.

"Amgen recommends a consolidated approach, when pre-requested documents are provided to inspectors through BOX, then a local inspector is allowed to the site (if allowed), who inspects the site within 1-3 hours, and then communication goes back to the online space." , - said the director for quality and external relations "Amgen" (Switzerland) Stefan Rönninger.

Olga Maklakova, Quality Director of AKRIKHIN, shared her successful experience of the repeated GMP inspection of the Warsaw pharmaceutical plant Polfa: “It was important to quickly and efficiently rebuild communications using digital technologies for virtual demonstration of the production site's readiness for conformity confirmation. The well-coordinated interaction of the site with the authorized representative, who was the link between the inspectorate and the manufacturer, was of great importance. Our experience in conducting inspections in this format was one of the first and became successful. "

Olga Maklakova shares the opinion of the inspectors that documentary inspection requires much more time, as well as the importance of the quality of translation of documents.

Matthias Schneiberger, Head of the Quality and Compliance Department of Roche, a strategic partner of the V All-Russian GMP Conference with international participation, also shared his experience in inspecting foreign production. In May 2020, FBU "SILS and NP" of the Ministry of Industry and Trade of Russia conducted a video inspection of the company's production site in Basel. This format was used for the first time in the country. Matthias Schneiberger advised manufacturers to pay close attention to the technical side of preparing an online inspection - cameras, IT services - and be sure to conduct a training tour. In addition, the expert recommended checking the local requirements and rules of the company regarding the disclosure of personal data of personnel and video recording. Roche also advises in advance:

• agree with the inspector of the premises / processes to be shown;

• provide floor / floor plans (inspectors will be able to "follow" the plan in parallel with the video tour);

• introduce all involved employees;

• start showing each room with a room number and a general floor plan with all equipment (process if applicable);

• allow time for questions.

Also at the master class, Roche demonstrated videos simulating an online inspection of the sample storage rooms and the microbiological control laboratory of a pharmaceutical plant.

As a result of a full day of GMP master class, both inspectors and representatives of drug manufacturers came to the conclusion that site inspections will be carried out as soon as circumstances permit. Remote inspections have become a necessary measure, which, despite its advantages, has disadvantages:

• require additional time and effort to prepare and conduct GMP inspections for both manufacturers and inspectors;

• some topics are difficult to demonstrate during the virtual tour - for example, the suitability of the production site for the declared processes;

• connection problems during the tour (eg in the -1 floor zones);

• significant labor / time is required for technical preparation and video organization;

• limited time to discuss potential issues (depending on the schedule).

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