Eu gmp annex 2

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Guidance on good manufacturing practice and good distribution practice: Questions and answers

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eu gmp annex 2

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eu gmp annex 2

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eu gmp annex 2

Confirm selection Select all.The product review is expected annually. Review timeframes can be appropriately adjusted based upon manufacturing and campaign duration with adequate justification. The timeframe criteria should be established in a SOP. The trending can include results gathered from the previous period to ensure its robustness.

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Even if no manufacturing has occurred in the review period, the quality and regulatory review should be conducted as per section 1. The review of the last PQR should also be conducted. Metal could originate from raw materials as well as from equipment in manufacturing processes where metal parts could generate fragments due to the conditions of operation or damage to the equipment.

In order to avoid routine use of metal detectors the company must demonstrate that it has identified and managed the risks such that the use of metal detectors for that particular process is not needed.

The document 'guidance on the occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers of active substances used as starting materials', published as part of the Community proceduresstates that it is expected that manufacturing-authorisation holders will gain assurance that the active substances they use are manufactured in accordance with GMP through audit of the active-substance suppliers.

Small manufacturers may not have the necessary expertise or resource to conduct their own audits. Section 5. An audit conducted by the manufacturing-authorisation holder itself should be integral to the manufacturer's quality-assurance system and subject to the basic GMP requirements, i.

It should be properly documented. These aspects can be inspected as necessary by the competent authorities. If a third party is involved, the arrangements should be subject to chapter 7 of the GMP guideline. There should be evidence that the contract-giver has evaluated the contract-acceptor with respect to the aspects described above.

All parties involved should be aware that audit reports and other documentation relating to the audit will be made available for inspection by the competent authorities if requested. This should normally provide sufficient assurance that the results of an audit carried by the third party are credible, thus waiving the need for an audit conducted by the manufacturing-authorisation holder itself. However, it must also be satisfactorily demonstrated that there are no conflicts of interests.

Conflicts of interests could arise for example from:.In the review period of about five years the volume increased from 5 to 32 pages. Already the draft for the second public consultation phase in see GMP News from 29 April indicated the comprehensive modifications and additions intended with the revision.

The tremendous developments in the area of biopharmaceutical products - especially the developments in the area of transgenic products and Advanced Therapy Medicinal Products ATMP - urgently required a review. The first significant modification already becomes obvious in the name of this Annex. In its version it only comprised "Biological Medicinal Products", while the new version now also covers "Biological Active Substances". In a new table the Annex shows what products and what production steps are concerned.

EU GMP Annex 2: Manufacture of Biological Medicinal Products for Human Use

Here it starts with the extraction of certain products as, e. To take into consideration the diversity of biological products the new Annex 2 is separated in two parts.

Part 1 comprises the general requirements relative to the issues. Personnel 2. Premises and Equipment 3.

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Animals 4. Documentation 5. Production 6. Starting and raw materials 7. Seed lot and cell bank system 8. Operating Principles 9.

Quality control. The structure is basically the same as before. The number of sub items - and this also means the covered details - has increased from 43 to 70, though. And not only the number increased, but also the gathered details of requirements for each sub item is a lot more comprehensive. For instance, the section on premises and equipment defines specifications with regard to requirements for design of buildings and processes with much more detail.

It also extensively describes specifics - e. According to the now included new types of biological products, the section on starting and raw materials is almost completely new or revised and complemented with an extensive part on human tissue and cells as starting materials.

The same applies to the section "Operating Principles" in the first part of the Annex. Many of the "modern" biological medicines are - in addition to the GMP Guidelines - also subject to specific guidelines and statues. Compared to the previous version, the many references to respective guidelines and specifications for the particular products as e. Annex 14 for blood, tissue guideline etc. Part 2 of the revised Annex 2 covers the special requirements with regard to the origin or respectively to the type of product.

The following groups are addressed:. Animal sourced products 2. Allergen products - materials manufactured by extraction from natural sources as well as by recombinant DNA technology 3.

Anmal Immonosera products 4.This second revision boasts a number of smaller and larger changes which we will explore in this post. Additionally, several small errors have been fixed. Following the first revision of Annex 1 the European Commission has received a great number of comments from the industry; as such it is now allowing further comments to be submitted.

The second targeted consultation aims at collecting experience from the sectors on certain manufacturing steps. The European Commission therefore expect to receive contribution from the European associations representing the sectors. There are a number of changes as opposed to the earlier draft of Annex 1. The following section was added:.

Where specific limits or frequencies are written, these should be considered as a minimum requirement. They are stated due to regulatory historical experience of issues that have previously been identified and have impacted the safety of patients. Most of the minor alterations in the new revision follow the spirit of that last sentence; bad experiences which the industry and regulators are trying to avoid in the future.

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More importantly, if you decide to implement parts of Annex 1 to non-sterile products you must comply to these parts in full. Exclusively monitoring or testing does not give assurance of sterility. We continue to observe organizations with near-perfect procedures but a complete absence of a solid understanding of the process, which choices were made during equipment validation or what the risk analysis was of the initial facility design. This guidance does not lay down detailed methods for determining the microbiological and particulate cleanliness of air, surfaces etc.

Further changes in the paragraph are more significant, with further clarification on how we expect workers and materials to enter cleanrooms, where revision one stated:.

Clean areas should be maintained to an appropriate cleanliness standard and supplied with air which has passed through filters of an appropriate efficiency. Cleanrooms should be maintained to an appropriate cleanliness standard and supplied with air which has passed through filters of an appropriate efficiency.

An Introduction to EU GMP (European Union Good Manufacturing Practices) Annex 1 - Part 2 of 2

Controls and monitoring should be scientifically justified and capable of evaluating the state of environmental conditions for cleanrooms, airlocks and pass-throughs used for material and equipment transfer. Their use should be considered in the CCS. Any alternative approaches to the use of RABS or isolators should be justified. Following this paragraph, the document details cleanroom grades, their purpose and expectations in each zone.Good manufacturing practice GMP describes the minimum standard that a medicines manufacturer must meet in their production processes.

Any manufacturer of medicines intended for the EU market, no matter where in the world it is located, must comply with GMP. The Agency has a coordinating role for GMP inspections of manufacturing sites for medicines whose marketing authorsation in the EU is submitted through the centralised procedure or as part of a referral procedure.

It is involved in:. The EU GMP guidelines provide interpretation of these principles and guidelinessupplemented by a series of annexes that modify or augment the detailed guidelines for certain types of product, or provide more specific guidance on a particular topic. Manufacturers and importers located in the European Economic Area EEA must hold an authorisation issued by the national competent authority of the Member State where they carry out these activities.

Importers are responsible to ensure that the third country manufacturer they are importing from comply with GMP. Marketing authorisation applicants are responsible to ensure that the proposed manufacturing sites included in the marketing auhtorisation application comply with GMP.

For more information, see section 5. Manufacturers of active substances intended for the manufacture of human medicines for the EU market must register with the national competent authority of the Member State where they are located.

Active substance manufacturers must comply with GMP. In addition, the manufacturer of the finished product is obliged to ensure that the active substances they use have been manufactured in compliance with GMP. Importers of active substances intended for the EU market are also required to register. In addition, each consignment needs to be accompanied by a confirmation by the competent authority of the country where it is produced that it conforms to GMP standards equivalent to those in the EU, unless a waiver applies.

In the EU, national competent authorities are responsible for inspecting manufacturing sites located within their own territories. Manufacturing sites outside the EU are inspected by the national competent authority of the Member State where the EU importer is located, unless a mutual recognition agreement MRA is in place between the EU and the country concerned.

If an MRA applies, the authorities mutually rely on each other's inspections. If products are imported directly into more than one Member State from a manufacturing site outside the EU, there may be more than one national competent authority responsible for inspecting it. EMA facilitates cooperation between the authorities concerned in supervising the site. EU competent authorities plan routine inspections following a risk-based approach, or if there is suspicion of non-compliance.

EudraGMDP is a publicly accessible EU database which contains manufacturing and import authorisations, registration of active substance manufacturers, GMP certificates and non-compliance statements. It meets at EMA four times a year. The European Commission and observers from EU accession coutnries, mutual recognition partner authorities, the European Directorate for the Quality of Medicines and HealthCare and the World Health Organization also attend the working group's meetings.

This facilitates cooperation between EU Member States and supports harmonisation and exchange of inspection-related information.

Good manufacturing practice

It covers the basis for national procedures that form part of the national inspectorates' quality systems:. For products derived from blood or blood plasma, EMA is responsible for coordinating inspections of the blood establishments in which collection, testing, processing, storage and distribution is carried out under the PMF certification procedure.

For more information on the PMF certification procedure, see Plasma master files.


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