4.3 Cooperation with third countries (2023)

FAQs

What are the requirements for GMP in the EU? ›

GMP requires that medicines: are of consistent high quality; are appropriate for their intended use; meet the requirements of the marketing authorisation or clinical trial authorisation.

If no agreement can be reached, the proposal is withdrawn. The EU treaties specify who can pass laws in what areas: the EU, national governments or both. EU countries are responsible for making their own decisions and laws in certain areas of national policy like industry, health and education.

Annex 1 of EU GMP provides specific guidance on the manufacture of sterile medicinal product. The new version of Annex 1 has been expanded considerably and now contains a strong focus on risk management and having a contamination control strategy.

The modern European Union, founded in 1992, has its origins in post–World War II attempts to integrate European economies and prevent future conflicts. It consists of seven major institutions and dozens of smaller bodies that make law, coordinate foreign affairs and trade, and manage a common budget.

Good manufacturing practices (GMPs) help to ensure the consistent quality and safety of products by focusing attention on five key elements, which are often referred to as the 5 P's of GMP—people, premises, processes, products and procedures (or paperwork).

GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.

Of the four major western European countries that are not EU members, Norway, Switzerland and Iceland have submitted membership applications in the past but subsequently frozen or withdrawn them, while the United Kingdom is a former member.

Membership negotiations cannot start until all EU governments agree, in the form of a unanimous decision by the EU Council, on a framework or mandate for negotiations with the candidate country.

Expulsion. While a state can be suspended, there is no provision to expel a member state outright. The idea appeared in the drafting of the European Constitution and the Lisbon Treaty but failed to be included. There are a number of considerations which make such a provision impractical.

EU GMP Annex 1 specifies limits of air-borne particles concentration for particle sizes > 0.5 µm and > 5.0 µm. The US FDA requests control of those for 0.5 µm only.

What is EU Guidelines Annex 11? ›

Annex 11 was created to ensure that when a computer is used in place of a manual operation in the manufacture of pharmaceuticals, there is no further risk to limb or paw when it comes to product quality, efficacy, or patent safety. While Annex 11 is not a legal requirement, it is a strongly recommended guideline..

While the FDA 21 CFR covers US-based pharmaceutical companies, Annex 11 is a Good Manufacturing Practice (GMP) guideline in the European Union. 21 CFR part 11 is a regulation of the FDA that applies to drug manufacturers, biotech companies and other regulated industries.

Norway had considered joining both the EEC and the European Union, but opted to decline following referendums in 1972 and 1994. According to the European Social Survey conducted in 2018, 73.6% of Norwegians would vote 'No' in a Referendum to join the European Union.

The EU has a strict set of criteria that candidates must meet in order to be accepted, and the process can take many years. The list of candidate countries currently includes Albania (2009), Montenegro (2008), North Macedonia (2004), Serbia (2009), Turkey (1987), Moldova (2022), and Turkey (2022).

Average EU member

On 23 June 2022, the European Parliament adopted a resolution calling for the immediate granting of candidate status for EU membership to Ukraine. On the same day, the European Council granted Ukraine the status of a candidate for accession to the EU.

Sample of the products needs to make sure that: (i) system is working; (ii) products meet specification; (iii) products will be effective for their intended use; and (iv) Products are safe.

Methods: The 5S methodology consists of the following steps: Sort, Set in Order, Shine, Standardize, and Sustain. A “red tag” exercise was conducted to identify critical versus unnecessary items in the work area.

The mainstay of GMP is the 4M principle; Men, machines, material and manufacturing premises. All these 4Ms are equally important.

Examples of good manufacturing practices that help ensure product safety and quality include: Incoming raw materials are inspected for quality. An allergen control program is in place. Product recalls are well-documented and controlled.

cGMP is a unique term to define most recent guidelines with improvement and additions. c is a variable in cGMP that's why it is written in small letter just like pH → p is variable potential in pH.

Why is Switzerland not in NATO? ›

According to Swiss president Ignazio Cassis in 2022 during a World Economic Forum speech, the laws of neutrality for Switzerland are based on The Hague agreement principles which include “no participation in wars; international cooperation but no membership in any military alliance; no provision of troops or weapons to ...

Chronology of the Swiss votes

6 December 1992: joining the European Economic Area is rejected by 50.3% of voters. This vote strongly highlighted the cultural divide between the German- and the French-speaking cantons, the Röstigraben.

Russia has chosen not to participate in the EU's European Neighbourhood Policy (ENP), as it aspires to be an "equal partner" of the EU (as opposed to the "junior partnership" that Russia sees in the ENP). Consequently, Russia and the EU agreed in 2005 to create four Common Spaces for cooperation in different spheres.

Since 2016, accession negotiations have stalled. The EU has accused and criticized Turkey for human rights violations and deficits in rule of law.

According to observers, this is due to such factors as the unwillingness of the EU to expand to the post-Soviet space, the poor performance of the Ukrainian economy, the lack of democracy (during the 1990s), and the internal instability (following the Orange Revolution).

Hungary is legally allowed to leave the EU according to Article 50 of the Treaty on European Union.

This clause provides that if a Member State is the victim of armed aggression on its territory, the other Member States have an obligation to aid and assist it by all the means in their power, in accordance with Article 51 of the Charter of the United Nations.

How do countries join the EU? Any European country that agrees to promote the EU's common values – respect for human dignity and human rights, freedom, democracy, equality and the rule of law – and meets certain conditions, referred to as the “Copenhagen criteria,” is eligible to apply for membership.

Annex I parties are industrialized nations and are legally bound to reduce greenhouse gas emissions once they have ratified the agreement. In contrast, Non-Annex I parties (developing nations) are only required to report emissions.

What is the difference between Annex I and Annex B? ›

Annex I refers to the 36 countries identified for reduction in the UNFCCC while the Annex B is an adjusted list of 39 countries identified under the more recent Kyoto Protocol. Annex B countries have their reduction targets formally stated.

China is a party to the United Nations Framework Convention on Climate Change (UNFCCC), and has ratified the Paris Agreement. It belongs to the non-Annex I groupof developing countries, which have less strict requirements and are entitled to support from the developed countries listed in Annex I of the convention.

This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use.

GAMP^® 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides pragmatic and practical industry guidance that aims to achieve compliant computerized systems that are fit for intended use in an efficient and effective manner, while also enabling innovation and technological advances.

Though Annex 11 is not a legal requirement, following its guidance is essential to compliance with related EU regulations. Aligning with Annex 11 can help make certain that the use of computers in the pharmaceuticals manufacturing process does not elevate quality, product and efficacy risks.

Part 11 is mainly about using electronic records and signatures in computer systems, while Annex 11 focuses on quality management of computerized systems. Part 11 requires electronic records and signatures to be trustworthy and reliable like paper records and handwritten signatures.

21 CFR Part 11 applies to clinical trial sponsors, including pharmaceutical and medical device companies, who are conducting FDA-regulated research. It also applies to Clinical Research Organizations (CROs) and research sites.

European Food Safety Authority (EFSA) : EFSA is an agency of the European Union set up in 2002 to serve as an impartial source of scientific advice to risk managers and to communicate on risks associated with the food chain.

Despite being a part of the European Union, Sweden remains outside the eurozone. The country held a referendum on joining the euro back in 2003, but a majority of the population decided not to adopt the single currency.

Serbia officially applied for European Union membership on 22 December 2009. Accession negotiations are currently ongoing. The latest report on Serbia's progress criticizes the country for a lack of reforms, issues with rule of law, issues with freedom of the press, as well as disalignment on geopolitical matters.

Why did Britain leave the EU? ›

Austerity. In managing their economy, the EU opted for austerity – resulting in significant problems for countries including Greece and Italy. Professor Whiteley believes austerity did not work, delayed economic recovery both in Europe and Britain and stimulated euroscepticism.

The European Council has not been asked to take a stance regarding whether or not Israel is a European state, but similar circumstances to Morocco (being geographically outside Europe and without exceptional features such as CoE membership) may preclude its inclusion as a full member into the EU as well.

The United Kingdom, which had acceded to the EU's predecessor in 1973, ceased to be an EU member state on 31 January 2020. No other member state has withdrawn from the EU and none has been suspended, although some dependent territories or semi-autonomous areas have left.

Nato membership, carrying with it a commitment from all member countries to protect each other if attacked, has long been a demand from Kyiv. Although Nato agreed in principle in 2008 that Ukraine could be allowed to join, the country has never been given a formal pathway to membership.

If Ukraine were to join NATO, the collective defence principle would mean the whole of the alliance was at war with Russia. The West has been toeing a precarious line when it comes to direct conflict with Moscow, and trying its best to avoid becoming an active participant in the current Ukraine war.

Relations between the European Union (EU) and Turkey were established in 1959, and the institutional framework was formalised with the 1963 Ankara Agreement. Albeit not officially part of the European Union, Turkey is one of the EU's main partners and both are members of the European Union–Turkey Customs Union.

EU GMP Annex 1 specifies limits of air-borne particles concentration for particle sizes > 0.5 µm and > 5.0 µm. The US FDA requests control of those for 0.5 µm only. There is no evidence that American drugs are worse.

This Annex 21 to the EU-GMP Guidelines now sets out the principles and requirements applicable to a Manufacturing and Import Authorisation (MIA) holder importing medicinal products (human and veterinary) across EU/EEA borders.

EU GMP Grade A is approximately equivalent to ISO 14644 Class 5. EU GMP Grade B is approximately equivalent to ISO 14644 Class 5. EU GMP Grade C is approximately equivalent to ISO 14644 Class 7. EU GMP Grade D is approximately equivalent to ISO 14644 Class 8.

Why 0.5 and 5 micron particle count required in pharma? ›

During non viable particle monitoring 0.5 and 5.0 micron particles are measured because most commonly found bacteria range is in between 0.5 to 5.0 micron so this range of particles are the main source of product contamination and can be carried from one area to another area very easily with the air movement.

The ISO 1 specification for cleanrooms require less than 2 particles greater than 0.3 microns and no particles greater than 1.0 microns per cubic meter.

The FDA standard classifies and monitors airborne particles at a single size threshold of ≥ 0.5 μm; EU and PIC/S use two size thresholds: ≥ 0.5 and 5.0 μm.

A Good Manufacturing Practices (GMP) audit checklist is a tool used by manufacturers to ensure that food, pharmaceutical, medical, and cosmetic products are of consistent quality and in compliance with manufacturing standards.

FDA conducts GMP validation for cleaning to ensure that no cross-contamination occurs between different batches. Ensuring the precision, accuracy and consistency of analytical tests in very important. A test method must be verified to be acceptable for intended use before it is applied to test the analytical samples.

The GMP certificate declares that the manufacturer complies with GMP, and the certificate includes a reference to the most recent date of the actual inspection, as well as which activities and under which legislation they have been inspected. A GMP certificate is issued to a site and refers to one specific address.

The revised Annex 13 changes the EU's approach to the management of issues that sit at the boundary between GMP and GCP. These include the two-step release procedure, handling and shipping of investigational medicinal products and contractual arrangements between the trial Sponsor and IMP manufacturer.

This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to ...

Annex 11 was created to ensure that when a computer is used in place of a manual operation in the manufacture of pharmaceuticals, there is no further risk to limb or paw when it comes to product quality, efficacy, or patent safety. While Annex 11 is not a legal requirement, it is a strongly recommended guideline..

Grade A – A zone for high-risk operations that need the highest level of environmental control. It's equivalent to ISO Class 5, both at rest and in operation. Grade B – A zone for aseptic preparation, filling, and compounding. It's equivalent to ISO Class 5 at rest and ISO Class 7 in operation.

What is the difference between Grade A and Grade B cleanrooms? ›

Grade A is the cleanest and is used for sterile operations. Grade B: This grade provides a background environment to enable aseptic preparation and filling for some grade A zone items. Grade C: Grade C cleanrooms are used to perform less critical activities needed for the non-critical manufacturing stages.

FDA classifies cleanrooms from ISO 5 to ISO 8. EU classifies cleanrooms from grade A to D. ISO 14644-1 specifies classes of air cleanliness in terms of the number of particles expressed as a concentration in air volume.