GMP Auditor

2021-06-28T06:35:38+00:00June 24th, 2021|

What is a GMP audit in Israel and abroad?

A GMP audit in israel is an audit that covers the Good Manufacturing Practices in the facility. GMP audit can be relevant for pharmaceutical, dietary supplements, cosmetics, and food industries. The GMP inspection is conducted to check whether a company complies with the relevant health authorities’ regulations such as the EMA, FDA, and to identify if you have full control over your processes, facility, and that the quality management system (QMS) is effective.

GMP Audit - article by bio chem experts

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Why do we need to conduct a GMP audits in israel?

The general definition of an audit or inspection is an evaluation of a person, organization, system, process, enterprise, project, or product. Quality and GMP Audits and inspections are critical functions within the pharmaceutical company. It provides management/health authority/client (in case you are an API supplier) with information about how effectively the company controls the quality of its processes and the safety and quality of its products, to minimize the risks.

In particular, the FDA cGMPs for pharmaceutical products require that an organization will conduct an internal quality audit as well as a third-party supplier audit to determine the effectiveness of its quality system.

GMP Auditors are typically part of the Quality Assurance (QA) or Regulatory Compliance area that has the relevant experience for examining the data trail to determine whether company policies and procedures are followed and implemented properly.

During a GMP audit, the organization should focus to demonstrate that the process of manufacturing drug substances and drug products within the scope and standards of Good Manufacturing Practices (GMP). Organizations should simply ensure that the following six things are completely controlled along with a separate quality control department:

  • Facility
  • Equipment
  • Raw materials
  • Operation
  • Training
  • Finished products

















    The Importance of quality system and GMP Audit in Israel’s Pharmaceutical Industry

    Auditing has become one of the important keys to the success of a pharmaceutical company. Regulatory agencies such as the Israeli Ministry of Health (IMOH)/FDA/EMA play a very important role in the pharmaceutical companies by ensuring good quality so that safe and effective product should be delivered to the public.

    • Pharmaceutical manufacturers commonly use audits as an effective mechanism to verify compliance with GMPs.
    • GMP Audits are intended to verify that manufacturing control systems are operating under the state of control.
    • GMP Audit can detect potential problems to permit timely correction.
    • GMP audits can assess the effectiveness of these QA systems and to ensure they follow GMP, self-inspection and other regulatory audits must be performed.
    • GMP audit ensures quality, all pharmaceutical manufacturers are required to establish and implement an effective pharmaceutical QA system.
    • GMP audits can be used to establish a high range of confidence to remain at an adequate level of control by Management.
    • Medicinal products have to be of high quality as people lives depend on them, although end-product testing of samples from each batch is important, it is not enough to ensure the safety and quality which must be built into the manufacturing processes

    Documents you need to know before the GMP inspection?

    Risk Assessment
    Identifies relevant risk factors that challenge an organizational area and further consider their relative significance.
    Scope Statement
    Identifies the activities that will be covered during the audit. This includes the project justification, the project description, the deliverables, and the success criteria.
    Audit Program
    Is a document that contains the listing of audit procedures as well as the objectives of the audit.
    Audit Procedures
    Are the specific tasks that the auditor follows to gather, analyze, and document during the audit.
    Workpapers
    Are the detailed documentation from interviews and testing conducted that will be reviewed to complete the audit program.

    The objectives of the GMP auditor

    • To determine the conformity or nonconformity of the quality system in meeting the specified requirements.
    • To determine the effectiveness of the implemented quality in meeting the specified Quality objectives.
    • To provide the Audit team with an opportunity to improve the Quality system.
    • To meet the regulatory requirement from the FDA/EMA or the Israeli Ministry of Health (IMOH)
    • To permit the listing of the audited organizations Quality systems in a register.

    For what purpose we need to conduct a GMP audit?

    • To initially evaluate the GMP capabilities of the supplier where there is a desire to establish a contractual relationship as part of the organizational supplier quality procedure.
    • To verify that organization’s quality system continues to meet specified requirements and is being implemented.
    • Within a framework a contractual relationship to verify the supplier’s quality system/GMP/GDP continues to meet specified requirements and is being implemented.
    • To evaluate an organization’s own quality system against quality system standards.

    Types of GMP audits and inspections

    • First-Party Audit- This type of audit also known as internal audit or self-audit those auditing and those being audited all belong to the same organization. (Ex. Q.A Department).
    • Second-Party Audit- A second-party audit refers to a customer conducting an audit on a supplier or contractor. (EX. QSR, ISO 9001 or ISO 13485 standards)
    • Third-Party Audit- Neither customer nor supplier conducts this type of audit. A regulatory agency or an independent body performs a third-party audit for compliance or certification or registration. (EX. FDA/EMA/IMOH investigator conducting a cGMP inspection at a pharmaceutical company).

     

    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.

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    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.

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    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.

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    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.

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    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.

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    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.

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    GMP and Quality auditing procedure

    • Notification
    • Planning
    • Opening meeting
    • Facility tour
    • Communication
    • Draft audit
    • Management response
    • Final meeting
    • Report distribution
    • Feedback

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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 GMP Audit queries.

      To get in touch please email us: info@bio-chem.co.il


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