EQPA Q&As

How to become a Qualified Person

Q: I am a Chemist. How can I become a QP?

A: In Article 49 of Directive 2001/83 (for veterinary medicinal products, please read Article 53 of Directive 2001/82) – please see the QP Regulations, the qualification level as well as the necessary professional experience of a QP is defined. The EU requirements as defined in these Directives have to be transferred to national law in each EU Member State. However, there are a number of differences in the EU Member States due to the fact that each Member State can implement the directives into national law with slight modifications.

Our recommendation is to discuss this matter with the respective authority in the Member State you plan to work as QP.

Q: Can companies outside the EU but with an MRA have a QP according the EU Directive. Can such a person be certified by the EU?

A: Things that need to be considered are:

The QP is linked to a European Manufacturing authorisation.
If the "QP" is an employee of a company outside the EU, he/she is not employed by a company with an European manufacturing authorisation and therefore can not act as a QP.
There is no such thing as a certification to be a QP. A QP is registered by the authority of the respective EU member state.

It is normal practice for a product manufacturer in a third country to have an EU-based importer who can provide the services of a QP? This EU-based QP would assess and certify a product/batch imported into the EU.Q: Does a QP from an EU Member State who is appointed by the Member State’s Main Pharmaceutical Inspectorate as a QP and is chemist and not a pharmacist can move to Germany and still carry out duties of QP?

A: Although the educational background would not be considered sufficient by the various local authorities in Germany to be initially accepted as a QP, a Chemist would be accepted once he/she is registered as a QP in another Member State. So once a QP is eligible and registered by another Member State authority he/she could apply as a QP in Germany. However it needs to be decided by the local German authority (e.g. Regierungspräsidium or local government). Many Member States require that a QP speaks the local language to be able to understand batch records, certificates and other GMP-related documents.

Q: If a company is based in Switzerland and produces pharmaceutical products, what are the possibilities to become a QP?

A: As Switzerland is not an EU Member State, the applicable Directives apply via the MRA.
The QP in Switzerland is called the "Fachtechnisch verantwortliche Person".
To become a Fachtechnisch verantwortliche Person, an academic qualification is needed (for finished products and intermediates usually a pharmacist). Other academic qualification is acceptable in case of proven experience and for APIs and blood products. The Notification is handled by Swiss Medic and the "Fachtechnisch verantwortliche Person" will be named on the manufacturing license. We would recommend contacting Swiss Medic for further information.

Q: There are certain professional bodies in UK who can grant QP status and can advise people that they are eligible for QP status as per EU Directives. However, it appears that some Member States do not recognise the defined education and experience requirements for becoming a QP as per EU Directives. In France for example the 'Pharmacien Responsable' has to be a pharmacist qualified and registered in France. Is it possible to operate as a QP recognised by markets where our products are commercialised (all EU), while not being considered a QP by the country of manufacture?

A: Directives are only binding as to the result to be achieved– and leave national authorities the choice of form and methods. The EU requirements as defined in the Directives have to be transferred to national law in each EU Member State. However, there are a number of differences in the EU Member States due to the fact that each Member State can implement the directives into national law with slight modifications. This national law is the binding one. To operate as a QP one has to be named by the holder of the marketing authorisation in the EU and must be registered/ accepted by the EU member state where the company resides.

Duties and responsibilities of the Qualified Person

Q: A company has recently been inspected by the respective national Inspectorate, and some of the observations in this inspection related to the role of the QP with respect to the quality system. For example, the authority asked for a description of the QP's responsibility with respect to the approval of controlled documents (documents in the quality system). Is this required in the QP relevant legislation?

A: It is a common misconception in these days that the QP is considered being responsible for all aspects of a Quality Management System, especially for approval of all kinds of documents, forms and reports.

Although the QP’s tasks and responsibilities are manifold it must be clearly stated that a QP is not automatically the Head of a Quality Management System, Head of Quality Assurance, or Head of a Quality Control Unit. This may be the case in smaller companies but very often, this is not the case. The QP then has to rely not only on other QPs but also on other staff and the Quality System, especially the Head of Production and the Head of Quality Control.

So it is the QP’s duty to ensure that certain pre-requisites are fulfilled as described in Annex 16 to the EU GMP Guide.

There is no requirement in the European regulations and Guidelines that the QP has to approve any other documents than the release documentation. However, a QP should be involved in the implementation and maintenance of the Quality (Management) System. But the QP is not obliged to implement and run the Quality System.

So if a company has a Quality Control Unit and/or a Quality Assurance Unit with experienced and authorised staff - why should the QP approve controlled documents?

Contract Qualified Persons

Q: Is there any guidance available defining “sufficient” time on a site to familiarise a Contract QP with the Quality System?

A: There is no guidance available. The time on site will depend on the complexity of the quality system. An important consideration is the maturity and stability of the system. If the system is mature and stable a shorter time on site may be indicated, provided that the contract specifies that the QP must be made aware of any changes that affect the quality system.

Q: Outsourcing the QP batch release:

what are the pre-requisites (GMP and legal)?
what experience is needed?
are there any existing models as a reference?

A: The QP must be endorsed by the competent local authority according to the national law. There must be a written agreement between the QP and the manufacturer, clearly describing the role and responsibility. The permanent availability of the QP must be assured, the frequency of on-site availability and the way the QP gets all relevant information must be defined. The QP must be appropriately experienced in the manufacture and quality control of the product type manufactured by the contract giver. In case the products need additional formal education or experience – like with regard to blood products, the QP must comply with these requirements.

Q: When IMPs are imported from outside the EU; how could I set up a working relationship as a contract QP when it comes to liability and insurance?

A: As a contract QP you are a “normal” contracting party (i.e. just like any other service provider for the company but with the specific legal responsibilities and risks of a QP) and therefore no employee of the company. That means that you are not covered by any of the insurance programmes which companies usually provide for their employees (e.g. D&O insurance). As a result, you should mention that fact – and the related legal risks – during your contract negotiations with the company.

Ideally, there should be an indemnification clause in the service contract providing for that ‘the company indemnifies the contract QP from any and all third party claims related to the services which the contract QP may perform under the service contract’. If your current contract does not contain such provision, you should ask the company to sign an amendment with aforesaid clause.

You can also ask the company to get yourself explicitly included in its D&O insurance contract (some insurers may actually be ready to do so because of the specific situation of the contract QP).This inclusion could be the first part of the contractual provision, followed by the indemnification clause mentioned above.

Release Decisions

Q: An API is contaminated with very small amounts of glass (<0.02%). The API is micronized and then pressed to tablets (oral). Giving the fact that glass has a very low toxicology; would you release the batch of the final product?

A: No. There is an excellent quote in the European Pharmacopoeia, Chapter 1. “General Notices, Tests and Assays”: “... It is not presumed, for example, that an impurity that is not detectable by means of the prescribed tests is tolerated if common sense and good pharmaceutical practice require that it be absent.” Good Manufacturing Practice and Good Pharmaceutical Practice require glass particles to be absent in APIs that will be used to manufacture oral solid preparations without any filtration step that would remove the particles! If during its production the API has undergone a last purification step by re-crystallisation after filtration using charcoal or a filter aid, this step should be repeated with the contaminated API (reprocessing) to remove the contaminant.

Q: A sterility test failed most likely because of a contamination during testing: is a re-test justified?

A: A retest of a positive sterility test must be very carefully justified based on a root cause investigation giving evidence that there has been a contamination in the laboratory during preparation or testing. It is not appropriate and acceptable to re-test based on mere suspicion. Reasons to invalidate a positive result would be e.g.

Microbiological monitoring of the sterility testing facility shows evidence for a failure like detection of the contaminant(s) in the testing environment. This has to be proven by genetic identity of both isolates!
Microbial growth is found in the negative controls
After identifying the microorganisms isolated from the test, the growth of this species can be clearly linked to failures with respect to the material and/or the technique used when conducting the sterility test procedure - e.g. contaminated media or non sterile sterility testing units

Q: A product (sterile eye drops) meets all specifications. However during production some microbiological monitoring results were not OK. Can I certify the batch?

A: Microbiological monitoring data are not describing the microbiological status of the batch itself. Monitoring data are considered to give information about the controlled environment. A level excursion in micro monitoring may be an indicator that there are deviations from the usual process, but they do not automatically indicate a microbiological problem of the batch. Following a positive outcome of a risk assessment of the non conforming monitoring results (type of contamination, level of contamination, place of the monitoring, other monitoring data, trending) it might well be possible to certify the batch.

Q: What should happen if OOS investigations are inconclusive?

A: The certifying Qualified Person should fully consider all of the information prior to making any decisions as to the final disposition of the batch. Any decision to release a batch where OOS results have not been invalidated should come only after a full investigation has shown that the OOS result does not reflect the quality of the batch. In making such a decision quality assurance and the Qualified Person should always err on the side of caution. (source: MHRA Q&A)

Role of the Qualified Person in the Company

Q: Is it possible to name more than one QP for the release of one certain product and if yes, can each QP be named as responsible for different sub-types of the product?

A: It is perfectly possible to name more that one QP and they can be named for different sub-types of product.

Q: Does the QP have to confirm acceptance of the company’s QA-System in writing or is signing of job descriptions and/or signing key-SOPs sufficient?

A: There is absolutely no regulatory or GMP requirement or expectation that a QP has to sign off job descriptions or key SOPs. In addition there is no formal requirement that a QP has to “confirm acceptance” of the company’s QA-System. Pharmaceutical manufactures usually run regular Quality Management Reviews that include a documented management assessment of the suitability of the Quality System. Therefore we would consider it appropriate and adequate that the QP is a regular member of this board.

Q: From a GMP and legal point of view, is there any problem that QP/QA and QC are the same person?

A: The only requirement under GMP is that the person responsible for production and the person responsible for quality control are independent. The QP can be the person who is also responsible for QC or the person who is responsible for QA (or both). In practice the QP certifying batches of product should not be the person who is responsible for their production.

Q: Who should sign the Quality Agreement? The QP only? QA? Legal? Head of production/QC? Business?

A: Quality Agreements should be considered GMP documents. Therefore involvement of the Legal Departments can be limited. According to the latest revision of chapter 7 of the EU GMP Guide (“Outsourced activities”) ... 7.12 “A contract should be drawn up between the Contract Giver and the Contract Acceptor which specifies their respective responsibilities and communication processes relating to the outsourced activities. Technical aspects of the contract should be drawn up by competent persons suitably knowledgeable in related outsourced activities and Good Manufacturing Practice.”

Chapter 2.7 of the revised chapter 2 of the EU GMP Guide (“Personnel”) states: “The heads of Production and Quality Control generally have some shared, or jointly exercised, responsibilities...— the approval and monitoring of contract manufacturers;”

Keeping these two chapters in mind, I would advocate for the Head of Production and Quality Control to sign a Quality Agreement. The QP must be informed, but there is no obligation for him/her to sign the Quality Agreement.

Q: If an audit required by Annex 16 is performed by corporate QA or a global QA function of the same company but part of different legal entity (e.g. from US), will I need a contract or is an SOP sufficient?

A: European understanding on different legal entities even within the same global company has to be considered as independent to each other in terms of GMP. According to Chapter 7 EU GMP all services contracted out should be covered by a contract. If such a service is provided to the QP by a global function it should be covered by a contract. Topics to be considered are provisions of influence on sequence, audit agenda, audit reports availability, auditor rating and possibilities to accompany the audit as an auditor.

Q: Annex 11 states that “There should be close cooperation between all relevant personnel such as Process Owner, System Owner, Qualified Persons and IT. All personnel should have appropriate qualifications, level of access and defined responsibilities to carry out their assigned duties.“ What should be understood by “close cooperation between all relevant personnel …”? What formal requirements should be observed?

A: No defined formal requirements exist for close co-operation between all relevant personnel during validation. But efforts must be made to ensure that a corresponding division of roles and tasks between the relevant personnel is clearly defined and implemented, including IT. (source: ECA Q&A)

Role of the Qualified Person in the Supply Chain

Q: What are the most critical elements of the supply chain requiring QP involvement?

A: First of all QPs must define the relevant supply chain, for many companies this starts from procurement of the raw materials (e.g. APIs, excipients, packaging components etc.), ending when the product reaches the customer. The QP then needs to identify what input is required at each stage, then either personally provide that input or delegate the activity to another person or department within the company and ensure to stay informed.

Q: Where does the responsibility of the QP end? When the product is handed over to wholesaler/RP?

A: Normally once the product is delivered to the customer it is assumed that the customer will take responsibility for the product from the point of receipt. If the product is supplied to a wholesaler, it very much depends on who owns the product, if the wholesaler has purchased the goods, then they should take responsibility. However, if the product at the wholesalers belongs to the QP’s company, then the QP continues to have the responsibility for the goods whilst at the wholesaler. The responsibility for the product at each stage of its life cycle should be clearly defined in the internal procedures, and where external parties involved (e.g. wholesalers) in the Technical (Quality) Agreement between the company and the wholesaler. It is possible for the QP to delegate this responsibility to the RP at the wholesaler, but this must be clearly defined (including the limitation which may apply) in the technical agreement. Please note that the QP retains the responsibility for recall of the products in the market place as well as ensuring that any product complaints have been fully investigated and appropriate corrective actions have been taken.

Q: What exactly is a GDP certificate? Will this be introduced in all Member States?

A: We are not sure if this is something every member state is going to issue after inspection.

The Qualified Person and Contract Manufacturing

Q: In case of an existing quality agreement, is it sufficient to rely on the certification of other QPs or should there be a review of for example batch records and deviations for the final batch certification?

A: In theory it is sufficient to rely on the certification of other QPs if the final certifying QP has knowledge of the other QPs and of the quality systems within which each of them is operating. In practice the final QP should be aware of any matter that might affect his/her decision to certify the batch (for example deviations or OOS results/investigations) and hence should review documentation from time-to-time, particularly if contract manufacturers and contract QPs are involved in the process.

Q: Is it allowed that a Quality Assurance function of the contract manufacturer can perform the audit of the contract manufacturer on behalf of the QP of the contract giver?

A: The audit must be performed by a qualified auditor who has no conflict of interest in the company being audited. This would mean that the contract manufacturer could not audit himself. But it would be quite acceptable to have an independent third-party auditor carry out the audit on behalf of the QP. It does not have to be carried out by the QP in person.

Q: PQR: A contract manufacturer is responsible for final batch certification but is not the MA-holder. Does the MA-holder have to have a copy of the PQR?

A: The answer is given in the full text of the EU Guidelines to Good Manufacturing Practice Part I, Chapter 1: “The manufacturer and, where different, marketing authorisation holder should evaluate the results of the review and an assessment made as to whether corrective and preventive action or any revalidation should be undertaken, under the Pharmaceutical Quality System. There should be management procedures for the ongoing management and review of these actions and the effectiveness of these procedures verified during self-inspection. (…) Where the marketing authorisation holder is not the manufacturer, there should be a technical agreement in place between the various parties that defines their respective responsibilities in producing the product quality review.”

The marketing authorisation holder is a key player and must have a copy of the PQR. How else could he be able to evaluate the result of this review?

Q: A contract manufacturer’s QP certifies a finished product, confirming the compliance with GMP. The QP of the MA-holder makes the final batch certification, confirming compliance with the MA. If the MA-holder is outside the EU, must the contract manufacturer’s QP confirm compliance with the MA?

A: Yes. Irrespective of the final release of the batch by some “QP” function outside the European Union it is the clear requirement of Article 51 of Directive 2001/83 that the QP releasing the batch in the EU has to ensure that 1. (a) “in the case of medicinal products manufactured within the Member States concerned, that each batch of medicinal products has been manufactured and checked in compliance with the laws in force in that Member State and in accordance with the requirements of the marketing authorization;”

Usually the Technical or Quality Agreement contains an annex, describing the requirements of the marketing authorisation like manufacturing process, test methods and specifications. This is signed by both parties. Any changes and variations then have to be handled via a change control system. This ensures that the QP of the contract manufacturer always has the appropriate information.

Q: A contract manufacturer’s QP certifies a finished product, confirming the compliance with GMP. The MA-holder provides artwork and labelling. What assurance should the QP of the contract manufacturer take as a minimum about compliance of artwork/ labelling with the MA?

A: There must be a Technical or Quality Agreement describing the requirements of the marketing authorisation like manufacturing process, test method and specifications. In case the contract manufacturer also performs secondary packaging, all relevant information of the packaging and labelling applying at the time of signature of the agreement must be included. This is signed by both parties. Any changes and variations have to be handled via a change control system. This ensures that the QP of the contract manufacturer always has the appropriate information.

Q: How do you perform batch record review of batches produced in China, when they are not bilingual or translated?

A: There must be a Technical Agreement and a recent audit of the company. If the company is supplying a finished drug product into the EU which needs a QP certification, a translation of one batch record as an example and a summary of each batch will be required together with a CoA. It is important that the QP can understand the process and whether there was any excursions/CAPA’s /changes etc. and what they were and how they were concluded. If this was a new company to the QP, and especially if supplying parenteral drugs, I would initially want an audit at least every 12 months until the relationship was fully established.

If the company is supplying APIs, the Technical Agreement and audit requirements and ability to understand any changes/excursions will still apply. I would also want to see a copy of the process flow document together with all the critical process parameters and be able to identify these comply on a batch to batch basis together with a CoA. The companies would also need to comply with all aspects of 2011/62/EU to the satisfaction of the QP and be accompanied by a written confirmation from the competent authority of the exporting third country which confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the EU (unless a waiver has been granted).

APIs and other Starting Materials

Q: Raw material for API production: are on-site audits required for all suppliers?

A: No; however a risk based supplier quality audit programme should be established. It is important to perform a risk analysis to determine whether a supplier needs to be audited.

Q: A batch of an API has been released before all testing and final approval was completed. How do I handle this in the certification of the final product?

A: Within the EU shipment of unapproved API is not be acceptable under EU law. For shipments outside of the EU the local laws would have to be checked. It would be necessary to check what is stated in the API producer’s SOP with reference to shipping unapproved material and whether that contravened any regulatory laws. The quality agreement between the API producer, the contract manufacturer and the MA holder should also be looked at to see if there is any reference to the movement of unapproved material being acceptable. It is not good practice to ship unapproved materials and as such this should have been picked up by the quality person releasing the API. Further, a deviation should have been raised and a full investigation carried out as to the root-cause. In addition the contract manufacturer should have quarantined this material on receipt and also raised a deviation to find out what went wrong. If this was a one-off incident and not a fundamental break down of the API’s manufacturers and/or the contract manufacturers Quality System, then as long as the API was formally approved, you should reference the deviation report and as long as everything else was in order, certify the final drug product. However, if this incident was part of a systematic failure of the Quality System would recommend not to certify the drug product as the potential for other GMP non-conformances would be too great. The follow-up to the deviation could involve an audit of the API producer initiated by the MA holder.

Q: How far down the manufacturing supply chain (finished API – intermediate – starting materials) has the QP to place consideration when preparing a GMP API declaration?

A: Based on a risk-assessment of the process the QP must evaluate the critical materials or critical steps. The QP can base his decisions on statements of authorised persons within a QA-System.

Q: API-supplier audit: If a big company is purchasing the API in bulk and then repackaging it and doing the QC testing and release, do I as the final QP need to audit the bulk manufacturer?

A: It is the responsibility of the QP for the MAH to assure that each step in the supply chain from the starting material onwards has been manufactured in accordance with GMP. In this example it would be necessary for the final QP to either audit, or have an approved auditor carry out an audit of the bulk manufacturer. This would be in addition to having a Quality Agreement in place between the bulk manufacturer and the drug product producer.

Q: Is a QP responsible to release an API?

A: No. The EU Guidelines to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use; Part II Basic Requirements for Active Substances used as Starting Materials does not contain a reference to a Qualified Person. It is the Quality Unit that has this responsibility.

But the QP is required to confirm in an EU marketing application that the API has been manufactured in accordance with Part 2 of EU GMP. It is important to emphasise that it is the QP who is certifying the final drug product and who has to give the assurance that the API has been made in accordance with the relevant GMPs. Hence the QP must have access to appropriate documentation including supplier audits (not necessarily by the QP themselves) together with a Quality Contract (Agreement) signed by both parties, to assure her-/himself that the API does comply with the valid standards.

However, some Member States may have differing national regulations that might require QPs for certain APIs, e.g. in Germany those APIs derived from a human, animal, microbiological source, and manufactured by biotech methods.

Q: How are APIs covered under the MRA? Do APIs from non-MRA states have to be retested?

A: An API has to be re-tested on receipt no matter where it comes from. In this case the MRA is irrelevant. Testing can only be reduced or eliminated (but the ID still must be done) until the supplier has been fully qualified and has provided materials over a period of time with no issues. An on-site audit of the supplier would also have to be undertaken to ensure the supplier is meeting the required standards.

Q: What is the minimum requirement/ expectation for supplier qualification of excipients? Are on-site audits required?

A: The minimum requirement is that starting materials (including excipients and others) and packaging materials are only purchased from approved suppliers. There is no regulatory requirement for on-site audits for excipient suppliers, this is only mandatory for APIs that are manufactured under GMPs. Nevertheless, own audits or qualified third party audits or joint audits should be considered as a part of the qualification programme for suppliers and distributors of excipients besides quality and delivery history, full analysis and performance based tests.

Q: Does the manufacture and purchase of raw materials represent an activity governed by Chapter 7 of the EU GMP Guide?

A: In principle, Chapter 7 covers all outsourced activities. Therefore, the general requirements for supplier selection, approval and performance management apply equally to raw materials as to other outsourced activities. There may not be a need for Quality/Technical Agreements (QTA) with the supplier; this will depend on the nature of the arrangement between the parties. For example, if the purchaser contracts the supplier to manufacture raw materials for them, then the arrangements would need to be covered by a Quality/Technical Agreement. However, if the purchaser simply buys raw materials from the supplier a QTA would not be required.

Q: The notice to applicants requires the submission of a declaration signed by the Qualified Person (QP) that the active substance used is manufactured in accordance with GMP. The active substance in my product is widely used, but not normally as a pharmaceutical active substance, and I am having some difficulty in confirming compliance. What should I do to furnish the required declaration?

A: Full compliance with GMP for finished products and active substances is a legal obligation for manufacturing-authorisation holders. It is recognised that for a small number of medicinal products, the primary use of the active substance is not in a medicinal product and the producer may therefore not be aiming to meet the specific requirements of pharmaceutical customers that represent an insignificant volume of business. Alternative sources should normally be sought, but in exceptional circumstances the manufacturing authorisation holder should assess and document to which extent GMP is complied with and provide a risk-based justification for the acceptance of any derogation. The declaration provided by the QP should set out in detail the basis for declaring that the standards applied provide the same level of assurance as GMP. The European Medicines Agency will collect experience with this approach, which can be used as a basis for discussion on related amendments to guidelines in the future. (source: EMA Q&A)

IMP-related questions

Q: Manufacturing of tablets for a phase I and for a phase II study: is it possible to release and/or submit an IMPD or similar documentation without microbiological quality as a lot release parameters for tablets in phase I or IIa? (tablets do not contain any component that would have a high total viable aerobic count by origin).

A: Especially for IMPs manufactured the first time it should be proved that the microbial quality is satisfactory, since usually only limited experience and only little validation data are available. Although the compounds are unlikely to be "contaminated", contamination may happen during manufacturing. Often the raw materials used for the manufacture are not tested for their MB status.

One approach could be to test at least the first 3 lots of a manufacturing sequence for MB status.

Independent of what is mentioned in the IMPD (and accepted by authorities), the QP keeps the final responsibility for the batch and should be able to justify her/his release decision. If the QP decides to release without MB testing, we would strongly recommend to perform a risk analysis of the release decision.

Q: Is it true and do the health agencies/ inspectorates accept that a company can import medicine from outside the EU and use it as an IMP in a clinical trial inside the EU without performing reanalysis within the EU? Is there a reference in the respective legislation?

A: That is indeed correct, Clinical trial Material (CTM) imported from a non-EU country into the EU does not need to be reanalysed/retested in Europe. This is covered in the Directive 2001/20/EC Article 13 (Manufacture and import of investigational medicinal products), at the end of paragraph 3:

“Insofar as the provisions laid down in (a), (b) or (c) are complied with, investigational medicinal products shall not have to undergo any further checks if they are imported into another Member State together with batch release certification signed by the qualified person”

In this article the QP certification act is described as well. In summary it mentions that the QP should certify that the CTM is compliant with:

European (or equivalent ) GMPs
The product specification file
The IMPD (Investigational Medicinal Product Dossier)

Remark:
-the IMP QP can always decide to reanalyse/ retest the imported CTM. Important to know is that this is not mandated by the EU HAs

Q: Should a QP audit CROs and investigators or can a QP rely on GCP-auditors of the own company?

A: The QP can rely on the information provided by the GCP auditors.

Q: When IMPs are imported from outside the EU; how could I set up a working relationship as a contract QP when it comes to liability and insurance?

Questions and Answers on Shared Audits Database "QPSHARE"

Background
GMP requires manufacturing authorisation holders to qualify their suppliers. In many cases this will involve an audit and in the case of suppliers of active substances an audit is a legal requirement. This can mean a lot of industry resource is used duplicating audits. Suppliers are inundated with requests to host audits conducted by, or on behalf of, their customers and can lead to audits being refused to minor customers. The European QP Association has therefore developed a tool that provides a way for QPs to share information on suppliers of common interest with a view to collaborating on audits. This benefits suppliers and customers.

It is recognised that QPs do not have a statutory duty to conduct or manage supplier audits themselves although their employer may choose to add this and other non-statutory responsibilities to their job descriptions. Either way QPs have a direct interest in supplier audits as supplier qualification is an important part of the Pharmaceutical Quality System upon which the QP ultimately relies when certifying batches prior to release. Furthermore, QPs are required to provide declarations on behalf of marketing authorisation holders or marketing authorisation applicants with respect to GMP compliance of active substance suppliers. These declarations must, by law, be based on the outcome of an audit.

What is QPSHARE?
QPSHARE is a free of charge database giving QPs the opportunity to improve the efficiency of the supplier audit programmes of their employing manufacturing authorisation holders. The approach is similar to that employed by various international authorities to identify sites that more than one authority wants to inspect.

By using the database you can identify suppliers that other manufacturing authorisation holders are also interested in auditing. QPSHARE will thus help you to contact the QPs of these companies with a view to sharing resources. QPSHARE is therefore primarily a communication tool and although its use may lead to some form of collaboration on audits, its function does not extend to the initiation or organisation of the audits themselves.

How can QPSHARE help?
Once you are in touch with other QPs interested in the same suppliers you may decide to organise a joint audit or agree to let another member’s organisation perform the audit and share the audit report, provided the auditee agrees to this procedure. The European QP Association is merely providing this tool and is not involved in these activities.

How does QPSHARE work?
QP Association Members submit names of suppliers and the products of interest that are to be audited. By entering this information in the QPSHARE database other members can then identify suppliers of common interested. Please see the list of suppliers (to get to the the list of suppliers, you need to log in first).

If you find a supplier that your employing manufacturing authorisation holder also needs to audit, you can just click on “send request”. All QPs who express an interest in this supplier will be informed via our communication tool. You will see how many QPs are interested in a specific supplier but you will not see their names for confidentiality reasons.

What about confidentiality?
The names of the QPs are not displayed. If a member would like to contact QPs in relation to a supplier of common interest, a button (“send a request”) sends an automated message to those other QPs. Recipients of this message may then decide to disclose their identity by directly contacting the colleague via e-mail. Further correspondence in relation to the audit is conducted outside of the QPSHARE application.

Be mindful of commercial confidentiality when using QPSHARE to initiate potential audit collaboration. QPs should ensure that their employing companies are happy to share information with third parties on what suppliers they use.

How can a member add a supplier if the supplier is not already listed?
You can submit the information via a contact form. The supplier will then be added to the list within 48 hours. Please provide sufficient details of the name, as this can change, and address of the site in order that it can be unambiguously identified. In some third countries where the local language does not use the Latin alphabet it can be a challenge for other members to be certain that the site is indeed the same as one for which they have an interest.

What regulatory considerations should be borne in mind with audit collaboration?
It has already been clarified that the application has fulfilled its role when bringing QPs together with a common interest in a supplier. Should contact made using QPSHARE lead to some form of audit collaboration that is a matter for the individuals and their companies to take forward. Nevertheless, it seems appropriate to remind QPs of the GMP aspects that must be taken into account.

There is no reason why two or more companies cannot conduct a joint audit of a supplier of common interest. Similarly, there is no reason why one company cannot conduct an audit on behalf of any number of other companies with an interest in the same supplier and share the resulting audit report. In both cases GMP rules require contractual arrangements to be established in accordance with Chapter 7 of the GMP Guide. It should be noted that such contractual arrangements must be established prior to the GMP activity in question and therefore the practice of selling audit reports after the fact would be in breach of GMP rules. EMA has published a Q&A on audits performed by a third party that draws attention to a number of things that need to be taken into account.

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