Cryoniss Accreditations and Standards.

Cryoniss exemplify quality, are highly regulated and have attained a number of exceptionally valued, sought after licences and accreditations.

These accreditations and standards allow Cryoniss to support our customers, no matter which stage of the drug discovery pipeline they happen to be at.

APHA Category 2

HSE Level 2

HTA 2004

MHRA

About Cryoniss Accreditations

Cryoniss are all about quality, and we are highly regulated and have attained a number of exceptionally valued, sought after licences and accreditations. Learn more about how our various credentials can help you and your organisation with your biological sample storage and end-to-end cold chain logistics needs. Our accreditations include the following, MHRA, HTA, HSE and APHA.

Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA supports innovation through scientific research and development. Part of the MHRA’s responsibility is ensuring that the supply chain for medicines, medical devices and blood components is safe and secure. Cryoniss holds a Wholesale Distribution Authority (Human) licence accreditation, enabling us to store and coordinate the logistics of human Medicinal Products.

Cryoniss is compliant with the following regulations:

• EC guidelines for GDP of Medicinal Products for Human Use.
• Directive 2001/83/EC Community Code relating to Medicinal Products for Human Use.
• Regulations 43-45 of the Human Medicines Regulations 2012.

Human Tissue Act 2004 (HTA).

The Human Tissue Authority (HTA) is the governing body created to regulate activities that come under the HT Act.

At Cryoniss, we are compliant with:

• Human Tissue Authority and the HTA Codes of Practice A & E.
• The Medicines for Human Use (Clinical Trials) Regulations 2004.
• EMA reflection paper for laboratories carrying out clinical analysis.

HSE Level 2 GMOs (HSE).

The HSE governs the following regulations that Cryoniss is compliant with:

• Genetically Modified Organisms (Contained Use) Regulations 2014 (‘the GMO(CU) Regulations’
• Control of Substances Hazardous to Health Regulations 2002. Cryoniss is licenced to store up to and including level 2 GMOs and adherence to these regulations enables Cryoniss to provide storage for a wide range of research tools and reagents.

APHA Category 2 (APHA).

As part of its remit, APHA provides security against animal and plant diseases, alongside other hazards. Animal by-products are defined as any material isolated from an animal (not human). ABPs can present a risk to human and animal health, in particular in relation to:

• Transmissible Spongiform Encephalopathies (TSEs).
• Dioxin contamination.
• Exotic diseases such as Classical Swine Fever and Foot and Mouth Disease. The APHA enforces the following European and UK regulations pertaining to the transport, storage, use and disposal of ABPs.
• Article 23 of regulation (EC) No. 1069/2009 – sites must be registered for use or disposal of Animal by-products (ABP) under 24hr prior notification to DEFRA for ABP importation.
• Animal by-products Enforcement (England) Regulations 2013 (ABPE) -establishments using animal by-products (ABPs) intended for research and diagnostic must be registered by APHA. Cryoniss is licenced to store Category 2 (High Risk) and Category 3 animal material at The Heath and Category 3 material at Alderley Park. Clients’ research samples often contain animal by-products (for example foetal bovine serum) or may even be taken directly from an animal, for example in vivo samples.

This APHA accreditation verifies that Cryoniss has the processes and procedures in place to ensure that these materials are stored in an appropriate manner.

Cryoniss Standards

ISO9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. It is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. Cryoniss is ISO9001 certified, with exemption from clause 8.3, design and development of products and services.

18517 – Cryoniss Ltd – ISO 9001 Headline Certificate.

18517 – Cryoniss Ltd – ISO 9001 Site 002 Certificate.

Cryoniss works to the principles of Good Laboratory Practice (GLP), Good Clinical Practice (GLP), Good Clinical Laboratory Practice (GCLP) and Good Manufacturing Practice (GMP . Samples are regulated by the Health and Safety Executive, Animal Plant and Health Agency and the Human Tissue Authority.

Alongside these Cryoniss adheres to regulations pertaining to The Medicines for Human Use (Clinical Trials) Regulations 2004 and European Medicines Agency reflection paper for laboratories carrying out clinical analysis.

To enable handling of medicinal products, Cryoniss complies with the EC guidelines for GDP of Medicinal Products for Human Use, Directive 2001/83/EC Community Code relating to Medicinal Products for Human Use and Regulations 43-45 of the Human Medicines Regulations 2012.

Samples are regulated by the Health and Safety Executive, Animal Plant and Health Agency and the Human Tissue Authority. Alongside these, Cryoniss adheres to regulations pertaining to The Medicines for Human Use (Clinical Trials) Regulations 2004 and European Medicines Agency reflection paper for laboratories carrying out clinical analysis.

Cryoniss is compliant with Good Distribution Practice (GDP) and holds a WDA(H) licence. To enable handling of medicinal products, Cryoniss complies with the EC guidelines for GDP of Medicinal Products for Human Use, Directive 2001/83/EC Community Code relating to Medicinal Products for Human Use and Regulations 43-45 of the Human Medicines Regulations 2012.

To enable handling of chemical compounds, Cryoniss complies with COSHH Regulations.

Quality Management System – a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. It helps coordinate and direct an organisation’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

For the purposes of alignment to the principles of GMP, the QMS is to be considered as the Pharmaceutical Quality Management System, and is referenced only as QMS. The Quality Assurance Programme monitors compliance against specific requirements of GxP as appropriate.

These accreditations allow Cryoniss to support our customers, no matter which stage of the drug discovery pipeline they happen to be at, allowing us to be there for our customers, every step of the way.