GMP, QMS , ISO 13485 & MDSAP Lead Auditor in Israel

Why do you need a GMP lead Auditor in Israel?

Israel is considered one of the leading countries in the Pharmaceutical, Medical Device, and E-Health industries, ranging from API manufacturers, Pharmaceutical drug products manufacturers, Biological product development and manufacturing, medical device facilities, and research laboratories.

A GMP audit in Israel is an audit that covers the Good Manufacturing Practices in the facility. GMP audits can be relevant for the 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, and FDA, and to identify if you have full control over your processes, facility, and quality management system (QMS) is effective.

Why Do We Need to Conduct 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 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 and have 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 on demonstrating that the process of manufacturing drug substances and drug products is 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 assurance department:

Facility
Equipment
Raw materials
Operation
Training
Finished products

The Importance of QMS 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 pharmaceutical companies by ensuring good quality so that safe and effective products are 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’s 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 that must be built into the manufacturing processes

Documents you need to have before the GMP inspection?

Risk Assessment

Identifies relevant risk factors that challenge an organizational area and further considers 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

These are the specific tasks that the auditor follows to gather, analyze, and document during the audit.

Work-papers

The detailed documentation from interviews and testing conducted will be reviewed to complete the audit program.

The Objectives of the GMP Auditor during the Inspection

As part of a GMP audit, the GMP auditor needs to cover the following:

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 organization’s Quality systems in a register.

For What Purpose Do 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 the 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

There are several common GMP audit types:

Audit Type	Audit details
First-Party Audit	This type of audit is also known as an 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 the customer nor the 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