As part of the validation and qualification activities for the production of medicinal products, the following question often arises: how many signatures have to be put under the respective protocols and reports? What is the responsibility of the Head of Production and the QA department in this matter? Indications can be found in the chapters 1, 2 and 4 of the EU GMP Guide Part I. You can find in Chapter 4 requirements on the topic Documentation: 4.2. Documents should be designed, prepared, reviewed, and distributed with care. 4.3. Documents containing instructions should be approved, signed and dated by appropriate and authorised persons. This can be summarized as follows: each document should have one author, one reviewer and one approver. The Head of Production is responsible for the qualification of his equipment and the validation of his processes (Chapter 2.7 (4)); the same applies to the Head of QC in the lab (2.8.). Since the introduction of the revised Chapter 2 in February this year, a new point has been added. Moreover - depending on the size and the organisational structure of the company - an independent Head of Quality Assurance or Quality Unit can be assigned. Where such a function exists usually some of the responsibilities described in 2.6, 2.7 and 2.8 are shared with the Head of Quality Control and Head of Production. Senior management should therefore take care that roles, responsibilities, and authorities are defined. This means for example that the QA can assume the tasks of the Head of Production. Basically, the QM system should ensure that validation is performed (1.4 (10)). Conclusion: Depending on your internal structure, you can specify the signature rules. You should be aware of what approved and released mean as both can have various meanings. Approved can be used for a document, for a technical review, for execution, or can even have a completely different meaning in conjunction with other terms. Similarly, depending on the term you use in combination with released its meaning is different, as, i.e., released formally or textually. Some companies set such definitions in a SOP documentation. Finally, the GMP Guide gives the freedom to do it otherwise; if you - at least - come to the same conclusion and can prove it. In the US, the procedure is slightly different. There, the personal responsibility of the Head of Production / QC is not part of the GMP regulation. On the contrary, it is the QCU who has a crucial role. The American Society of Testing and Materials (ASTM) has a quite different approach. The document ASTM E 2500 defines Subject Matter Experts for qualification. According to this model, the QA department would only sign superordinate qualification documents. This is an interesting and lean approach although not very common Europe yet. [20:08, 20/12/2014] +91 87937 20390: The ICH has recently announced in a Business Plan and a Final Concept Paper the establishment of a working group whose task will be to elaborate training materials on the Guideline ICH Q3D Elemental Impurities. The ICH justifies the necessity of providing support with regard to the implementation of ICH Q3D in the form of training materials based on the experience made with the Q8, Q9, Q10 and Q11 guidelines. After the publication of those guidelines, it has come to various interpretations within and outside the ICH regions despite clear linguistic and unambiguously formulated text in these guidelines. After that, IWGs (Implementation Working Groups) have been established which elaborated training materials to provide support for the implementation of these guidelines. Based on these experiences, the ICH now wants to avoid if possible the ambiguity phase and divergent interpretation of the requirements of ICH Q3D and provide the training materials in time. The wording in the Business Plan and the Concept Paper suggest that the availability of those materials shall follow the publication of ICH Q3D (Step 4) in quick succession. This means that the publication of ICH Q3D (Step 4), which has already been adopted and is supposed to replace the Draft Consensus Guideline ICH Q3D (Step 2b) will probably still take some time! The timing described in both the Concept Paper and the Business Plan includes the following milestones: Agreement of Concept Paper and Business Plan by the Q3D EWG: 3 October 2014 Adoption of Concept Paper and Business Plan by the ICH Steering Committee: 21 October 2014 Establishment of the ICH Q3D IWG: 31 October 2014 IWG meeting to finalize training materials: 1st quarter of 2015 Training materials finalised: 31 March 2015 The agenda of the ICH Q3D IWG include the following activities: Elaboration of training presentations including: - General overview of the guideline and examples of the execution of risk assessments - Examples of application of the guideline to less than daily dosing - Examples of application of the guideline to other routes of administration Development of a Questions & Answers document with frequently asked questions (FAQ) Creation of a document providing an approach to documenting the information/data supporting the risk assessment to be presented in a regulatory submission Supplying the training materials with expert support for workshops and/or web-based sessions Hereof, the ICH expects a large elimination of ambiguities and a harmonised implementation of the requirements laid down in the guideline.
Posted on: Mon, 22 Dec 2014 11:53:25 +0000
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