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Q&A Session at the QP Forum 2008 in Munich, Germany – Part III

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

  2. How should a QP proceed in case the CEP of the API manufacturer is suspended for example because of GMP violations? Can the QP release the finished product after doing a risk assessment?
    It would depend on why the CEP was suspended. The QP would certainly have to carryout a risk assessment and get assurance that the API being manufactured was compliant and had not had its safety, quality or efficacy compromised. If I was the QP I would want to discuss with the regulatory authorities before approving any product made from the API

  3. How many QPs have actually been sent to jail in case of violations?
    We are currently not aware of anybody in EC sent to jail. The penalties for nonconforming behaviour of QPs are mostly leading to fines and no to terms of imprisonment. The last may be relevant in cases of intentional release of unsafe products or danger for patients.

  4. Annex 13 requires that the QP must have experience with clinical trials. What do inspectors/ regulators expect with respect to QP experience with GCP.
    I would expect knowledge of GCP-basics, and besides the usual GMP, galenic experiences and experiences in handling new materials and knowledge of the various processes from phase 1 to phase 3.

  5. What is the minimum requirement/ expectation for supplier qualification of excipients? Are on-site audits required?
    The minimum requirement is that starting materials (including excipients and others) and packaging materials are only purchased from approved suppliers named in the specification.
    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 to audits or joint audits must be considered the most appropriate way to approve suppliers and distributors of excipients.
    This will from time to time be problematic or impossible, as unlike APIs, excipients are not usually manufactured specifically for use in medicinal products and only very limited amounts are delivered for pharmaceutical use. In this case a preliminary approval based on delivery history, fully analysis and performance based tests to show equivalent drug performance and stability should be performed.

  6. 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?
    The QP must be named in the manufacturing authorisation (in Germany). 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 blood products, the QP must comply with these requirements.

  7. PQR: A contract manufacturer is responsible for batch release but is not the MA-holder. Does the MA-holder have to have a copy of the PQR?
    The answer is given in the full text of the EU Guidelines to Good Manufacturing Practice Part I, Chapter 1, Quality Management, 1.4 Product Quality Review, chapters 2 and 3:
    The manufacturer and marketing authorisation holder, where different, should evaluate the results of this review and an assessment should be made whether corrective and preventative action or any revalidation should be undertaken. Reasons for such corrective actions should be documented. Agreed corrective and preventative actions should be completed in a timely and effective manner. There should be management procedures for the ongoing management and review of these actions and the effectiveness of these procedures verified during self-inspection. Quality reviews may be grouped by product type, e.g. solid dosage forms, liquid dosage forms, sterile products, etc. where scientifically justified.
    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 quality review. The Qualified Person responsible for final batch certification together with the marketing authorisation holder should ensure that the quality review is performed in a timely manner and is accurate.
    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?

  8. 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?
    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 I consider it appropriate and adequate that the QP is a regular member of this board.

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