Below is an extensive list of questions and answers
that are here to inform you further on
the full spectrum of concerns facing compliance and validation.

The new European Medical Devices Regulation was published on 5th May 2017. The Regulations will come into force on May 25th 2017, marking the start of the transition period for manufacturers selling medical devices into Europe. The MDR, replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), and has a transition period of three years.

Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements. The Regulation should be referred to for more detail.

the new requirements will be applied to all devices only when they are to be certified under MDR. After the transition period, devices not conforming to the MDR will need to be removed from the market.

The notified bodies will need to be designated under the new MDR as the old MDD certificates will only be valid for a limited period of time. The competent authority will designate notified bodies to begin auditing under the new MDR

Pharmi Med can help in carrying out an initial Gap Analysis and make your audit ready for the new MDR.

All medical devices will need to comply with the requirements of the MDR to be certified under the MDR. The MDR requires manufacturers to demonstrate an effective QMS. In order to be certified to the new MDR your QMS must comply with its requirements. The regulations are currently not harmonised with ISO 13485: 2016, while there is also a current three year transition period to the new revision of ISO 13485 this applies great pressure for manufacturers to keep their devices on the market. Manufacturers will also need to prepare for unannounced audits.

A big shift in Clinical data and possible testing to ISO 10993 even for an equivalent device. The new MDR has safety and performance requirements called out. The Clinical Evaluation needs to be updated periodically based on Post Market Surveillance (PMS) data.

The need for more Post market Surveillance has increased.
The responsibilities for Notified bodies has also significantly increased. An Introduction of UDI (Unique Device Identification)

The European database known as EUDAMED will be used and the transition period may follow the new MDR or have independent regulations such as that of the GUDID under the FDA. A UDI will be needed on each packaging on each item. Annex VI Part C Section 6.5 of the Regulation can be consulted for further information. There are many similarities between the FDA requirements which have been running for several years now.

It will be necessary for manufacturers to complete a gap analysis of the requirements of the EU over those of other Regulatory Authorities already requiring UDI, Pharmi Med can help perform this. For more information, see Annex VI of the MDR.

Pharmi Med Ltd. has a network of proficient Clinical, regulatory and Quality professionals from scientific and engineering backgrounds. This enables us to understand your product and the difficulties you are facing and quite possibly will face with the enduring regulations that are invoked to keep your company operational and profitable. Pharmi Med Ltd. can perform an initial Gap analysis against the regulations and prepare you for your audit. We can perform an internal audit and put in place a paper QMS or set you up with an electronic QMS with our partners Greenlight Guru.

You will need to do Validation if you are regulated by the FDA to sell to the US market, MHRA for the European market and other specific regulatory bodies for other parts of the world. If you have a licensed product or a Medical Device which is Class 1, 2 or 3 you will need to do Validation.

By using Validation principles, the regulatory standards will be able to judge your commitment to quality and assurance that your product is meeting utmost standards for human consumption, implant or general use.

The Validation system should be written into the Quality Management System, therefore this should be written/approved by the Owner, senior most person responsible on site. But ultimately everyone is responsible for validation, but this usually sits with the Quality department or Engineering department.

Based on the complexity of the system, equipment, process a gap analysis is performed and decision will be made to the degree of validation work.

Pharmi Med can help from any stage of validation from original procedure set up, to assistance with new product development, to ongoing validation, or even remedian plans from audits which have found that your system has some shortcomings.

Pharmi Med is experienced in Pharmaceutical, Medical Device and Biotech. Pharmi Med has experience of Start Ups as well as Multinational Giants. Pharmi Med is flexible with their approach and services.

Templates are good if you don’t know where to start but have resource to fill in the blanks. Provided with appropriate training your staff can easily validate simple systems.

Using contractors can be an ongoing cost, Pharmi Med can provide either a short service or longer term commitment, either way whatever suits your needs.

The nature or validation is usually project based, therefore the lifecycle is limited to a few months to a few years, therefore taking a commitment with permanent staff to do validations just does not make sense. Validation by nature comes and goes in peaks in troughs.

For the User Requirement Specification, you will need a clear outline brief as to what you are purchasing, requirements, what you want the equipment to do. (Link to URS template)

You will need to outline all Installation Requirements (Link to IQ template)

You will need to outline all the Operational Requirements (Link to OQ template)

You will need to outline all your Performance Requirements (Link to PQ template)

Standard Operating Procedure, is the way you are instructing that something is done and needs to be followed so that a procedure is standardized and done in the same way by everyone.

The FDS is a Functional Design Specification and is usually the document that the equipment supplier will provide you in response to your URS. The DQ is the Design Qualification which you need to outline in further detail how the equipment will work, operate and its design functions.

The Factory Acceptance Testing or Site Acceptance Testing is either the testing done at supplier site before dispatch or the tests done at your site upon delivery to check for damage prior to performing Commissioning and Qualification.

Good Automated Manufacturing Practice, is a guideline set by the ISPE (International Society of Pharmaceutical Engineers), it is a set of guidelines compiled by specialists in the industry to provide guidelines for commissioning and qualification.

Qualification is the heart of Validation IQ,OQ, PQ, or a subset. Validation is the entire process.

If the system is using software this will need validated separately by challenging the software and its functions.

If you don’t have access to the code (White Box), or expertise then a justification to test only the outputs (Blackbox) is sufficient.

Where you have a system that is not clearly defined as Validation you can perform a sanity check by doing verification checks, this can be as a matter of good practice.

Yes, Pharmi Med has experience of assisting startup companies for their validation.

Yes, Pharmi Med has experience in preparing for audits

Yes, Pharmi Med has experience of remediation plans for MHRA and FDA

Part 11 is a subset of 21 CFR (Code for Federal Regulations), and this is the legal regulations used by the FDA, while Annex 11 is the equivalent used by MHRA

Any of the systems that need Good Practise, such as GDP (Good Documentation Practise), GMP (Good Manufacturing Practise), GEP (Good Engineering Practise).

Before performing the validation a Gap analysis is performed to make an assessment to the amount of work needed.

According to the FDA and MHRA any testing performed for validation must be calculated on the basis of a sampling plan statistically, this requires assessment using an AQL (Acceptable Quality Limit) to protect you as the manufacturer and LTPD (Lot Tolerance Percent Defective) as the customer.

Yes for the reasons just mentioned.

Failure Mode Effects Analysis, a method developed by the automotive industry to challenge the “what ifs?” of product, process and design.

A measurement technique developed by Motorola to ensure 99.99% good product in a batch using tools and techniques.

Lean manufacturing is manufacturing with minimal waste.

Housekeeping, organization and discipline of the workplace.

Accordion Content

Total Productive Maintenance, a system developed by Toyota to ensure optimum efficiency of a plant and minimal downtime.

Overall Equipment Efficiency, is a tool used to identify the losses of equipment to maximize efficiency by exposing defects by monitoring Availability, Performance and Quality aspects of equipment.

Quality Systems Regulations a subset of the FDA.

This is the exact subset that the FDA use to ensure you are compliant to serve the US market for Medical Device.

This is the exact subset the FDA use to ensure you are compliant to serve the US market for pharmaceuticals.

This is the subset used by the MHRA to ensure GMP.

This is the ISO (International) Standard for Medical Device.

Yes, get in touch via the Contact form.

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SERVICES

Our Validation expertise expand in all arenas from Software Validation to Facility Validation.

TEMPLATES

Our tried and tested templates offered throughout the industries have something for everyone from our pay and download section.

REMEDIATION

Pharmi Med Ltd has a multitude of experience with FDA and notified body remediation activities.

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