2022-03-12T21:15:25+00:00January 15th, 2022|

Why is Lead Auditor services in Israel are relevant for you?

It is a well-known fact that companies from the medical device and pharmaceutical industries in Israel and abroad need to follow strict regulatory requirements. Part of the effort that should be given is finding the appropriate lead auditor in Israel to authorize, qualify and approve your external service providers and suppliers.

Lead Auditor in Israel

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Lead Auditor in Israel - Bio Chem
Lead Auditor in Israel - Bio Chem
Lead Auditor in Israel - Bio Chem
Lead Auditor in Israel - Bio Chem
Lead Auditor in Israel - Bio Chem
Lead Auditor in Israel - Bio Chem

In addition, all companies are using third-party services as part of their routine operations. These third-party services can be used for a variety of activities such as:

  • Development
  • Raw materials and APIs
  • Device components
  • Manufacturing
  • Assembly
  • Packaging
  • Sterilization
  • Storage
  • Transportation
  • Laboratory testing
  • Stability studies

These kinds of services can be given from local suppliers or global ones, and both need to be audited for their QMS, GMP, and regulatory requirements compliance.

Global audits and quality inspections in the pharmaceutical and medical device industries

The Bio-Med industry has become massively global in the past two decades. It means you have many business partners, suppliers, service providers, and contract manufacturers in many countries, and you have to be sure they maintain their quality-related obligations and duties.

For example, A typical company may have API supplier from Israel, a contract manufacturer from India, and a testing laboratory from Germany. In order to comply with the ISO 13485/GMP/FDA/EMA regulations, we need to have worldwide auditing and inspection capabilities that will enable us to meet the regulatory requirements and avoid observations in the regulatory body’s inspection.

All of these suppliers need to have a third-party audit periodically, and in most cases, you need to hire an external lead auditor service to do it right.

Quality system audits and inspection areas

As part of the quality management system, such as the ISO 13495, MDSAP, and the GMP requirements, you need to have control over many critical points that may affect your manufacturing and assembly processes as well as your final product safety and quality.

The main pillars of the quality management system in the medical device, pharmaceutical, and even digital health companies are:

Audited area Audit purpose

Facility & Equipment

To ensure your supplier’s facility and equipment meets the design standards, are operated and maintained properly, and in a validated state

Production & Assembly

To ensure your product/device assembly and manufacturing processes are controlled, performed based on the approved working instructions and that all processes from raw material/components receiving until final product storage are documented, controlled appropriately, and performed by qualified personnel

Quality system

To ensure your supplier’s QMS documents were written and approved based on the relevant and current regulatory requirements, the quality management system and good practices implemented correctly, and there are no gaps between what is written and what is actually done on the production floor

Quality Control

To ensure there is proper quality control and testing over components, materials, manufacturing, in-process, printed material, packaging, and the final product before release, it is being done based on well-written SOPs and instructions

Self-inspection

To assure all your company’s departments constantly follow the procedures, good practices, and quality aspects routinely

Return and complaints

To ensure all post-marketing procedures are implemented, product returns and customer complaints are being documented and managed in a controlled manner for a continuous improvement

Organisation & personnel

To ensure the company’s organisational chart supports product quality and safety, reduces the potential risks and conflict of interest, and assures that all personnel has the education, experience, training, and qualification to do their jobs appropriately

Outsourced operation

To assure the company’s suppliers, contractors, and service providers were chosen carefully and can deliver high-quality and reliable services/safe products, that they were qualified based on a questionnaire, that a quality agreement was signed, that they maintain a quality management system, and that they were inspected before approval and periodically

Documentation

That all the processes related to the product, from supplier approval until final product distribution, are adequately documented, using controlled documents, policies, SOPs, and protocols, and that all the required QMS, ISMS, and GMP documents were written and approved

Outsourced operations are considered very critical and risky areas in the Bio-Med industry, and accordingly, a particular emphasis is given to outsourced operations

You can have a well organised and effective quality management system. Still, you cannot guarantee your critical supplier does the same, and that is why you need to hire an external auditor service.

















    Second and third party audits

    The regulation expects the company to have exceptional control over its suppliers and conduct self-inspections internally as well. Second and third-party audits are very common practices in the pharma and medical device industries.

    Regulatory agencies and business partners will audit you, and on the other hand, you need to audit your partners, service providers, and suppliers.

    It is your responsibility to work with qualified third parties.

    You need to report to the regulatory authorities in case of deviation, customer complaint, or recall. You have to assure your suppliers and contract manufacturers maintain an effective quality system and follow what has been agreed and signed as part of the quality agreement.

    Bio-Chem Stamp of Approval

    Common audits and inspections  in the medical and pharma industries

    Here are some audit types that should be performed in pharma and medical device companies:

    • Raw materials suppliers’ audits
    • Medical components and parts audits
    • Laboratory services audits
    • Service providers’ audits
    • Equipment manufacturers’ audits
    • Contract manufacturers’ audits
    • Sterilization service provider audits

     

    Research and development

    Consulting in a variety of areas, including design, research laboratories and clean rooms, development technologies, investor business presentations, regulatory strategies, market analysis, clinical trial protocols, GLP, GCP, ISO 17025, calibration, CMC and professional training.

    read more

    Design and engineering

    Designing factories, clean rooms and laboratories, engineering documentation, certification, technology selection, process engineering, and validation, with a combination of theoretical knowledge, practical experience, and in-depth understanding of biomed regulations and in accordance with GxP principles.

    read more

    Manufacture and packaging

    Consulting on manufacturing plant design, manufacturing process development and engineering, selecting the most appropriate technology, process scale-up, technology transfer, GMP, process improvement, yield optimization and improvement, employee training, validation of equipment, systems, and production and cleaning processes.

    read more

    GxP, quality and validation

    Advises, establishes, accompanies and upgrades various types of quality management systems, offers GMP training and courses, coordinates adoption of GxP principles, ISO 13485, quality assurance and preparation for global regulatory audits while conducting risk analysis and evaluation, and verification and validation of equipment, systems, software, test methods, manufacturing and cleaning processes, until  a successful audit outcome is obtained.

    read more

    Regulation and registration

    Regulatory consulting and drug registration,  medical devices, CE mark, dietary/nutritional supplements and cosmetics in Israel and worldwide, building a smart regulatory strategy, helping to prepare documents and meet requirements in a professional manner, in a short time, product labeling, shelf life and graphics, import licenses and meetings with regulatory bodies, until approval  (marketing authorization) is received.

    read more

    Software and systems

    Digital healthcare consulting, software development and medical applications in accordance with US  FDA 21 CFR part 11 / EU Annex 11 / US HIPAA / EU GDPR requirements, ISO 13485/ISO 27001/ISO 27799, CE marking, risk assessment, verification and validation of software and control systems until marketing authorization (approval) is obtained.

    read more

     Lead auditor services in Israel

    There are thousands of medical devices, pharmaceutical and digital health companies, service providers, and contractors in Israel. Most of these companies are operated globally and need to be audited and inspected periodically. 

    I’m a certified lead auditor based in Israel, work worldwide, and internationally registered auditor in the IRCA.

    There are many advantages to using a local Israeli certified lead auditor services to assure your supplier can be fully trusted and follow the regulatory requirements. 

    I was recognized and accredited by the global NSF, IRCA, and CQI, with a proven track record of many first and second-party audits worldwide.

    With more than 20 years of experience in the pharma, medical device, and digital health industries, I offer my clients my lead auditor capabilities in Israel and globally according to various audits regulations such as: 

    • ISO 13485
    • Eu. GMP 
    • US GMP 21 CFR210/211
    • EU GDP Guide
    • FDA 21 CFR 820
    • Vefification & Validation
    • Sterilization
    • GDP
    • MDSAP
    • ISO 27001
    • ISO 27799
    • GDPR
    • HIPAA
    • And many more

    DD or regulatory body inspections are a significant milestone for all Medical devices, E-Health, and pharmaceutical

    To ensure you choose the best partners along the way to meet the regulatory requirements, you need auditing capabilities and proper guidance.

    I’m offering my lead auditor services and consulting for Bio-Med clients for second-party and third-party audits in Israel and worldwide.

    Document Template Store

    We are proud and excited to share our global professional experience from the past 15 years and to introduce a New service of professional template documents that aims to assist you with the processes of planning, constructions, regulation, quality, GXP, and information security and a wide range of other areas while saving time and money

    for more details visit our document store

    bio-chem company logo
    • Template documents can be customized for immediate download
    • A wide range of forms in different categories from the worlds of pharma and bio-med Based on hundreds of projects that have undergone similar processes successfully
    • Huge savings in time and money
    • resources Instructions for use are clear and simple
    • Possibility to receive advice and examine the documents
    Lead Auditor in Israel - Bio Chem

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    Eran Yona Bio-Chem Founder and CEO

    Bio-Chem has been advising biomedical companies for more than 15 years.

    We are here to help with and Lead Audit queries.

    To get in touch please email us: [email protected]

     

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