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Inspection

Is your company ready for inspection?

We will cooperate with you to get your company ready for national and international audits and inspections.

Whatever your company’s role in the pharmaceutical supply chain is-whether it is a supplier, manufacturing or even accretors – you need to demonstrate Good Manufacturing Practice (GMP) to gain customers’ trust and build an impeccable reputation.

We run the consultancy company in Iran and gather a team of experienced and knowledgeable auditors and consultants who have experiences of internal and international auditing. We will consider all of your concerns and obstacles according to your system and design, and implement the best and cost-effective situation to demonstrate your commitment to quality and safety across the pharmaceutical supply chain.

Additionally, after the audit, we will provide a CAPA handling form and identify Major and critical cases and recommendations to help you expand your business.

Our Audit Services
Audit procedure
Our GxP Audit Services
Units Specific Audit
Our Audit Services
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Quality System Management
SOP+ Training + Internal Audit
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Audit & Report
Audit + Report + followup + Efficacy
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Regulatory Report Findings Deviation
CAPA handling + Efficacy
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Third-party Audit
Periodic Audit + Report
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Target Audit
the specific facility, process Audit
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Contact Us
Free Advise
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Quality management system implementation

Although the regulatory decision is based on certain practices and requirements due to documentation, manufacturing companies should obtain a perfect quality system and culture in their whole company to fully comply with GMP requirements.

We figure out that one of the most repeated noncompliance issues in regulatory reports nowadays is related to quality management system gaps.

In hence, not only we audit and check sites, but also assist you to implement a perfect and efficient quality management system step by step which include providing SOP, efficient training program and periodic internal audits.

Regulatory report finding nonconformity!

Even when you implement the perfect quality management system, documentation proceed and performing periodic internal audits you might receive nonconformity reports in which being asked to give the most effective corrective actions in timely manners.

We support and cooperate with you to provide and design the efficient CAPA program along with analyzing and identifying root causes and effectiveness checks.

Output:

  • Design CAPA handling Process
  • CAPA effectiveness assessment

  • Analyzing and identifying root causes

Target audit

In some cases, there is only a need to audit a specific facility or process and might be costly and time-wasting to audit the whole site. In this situation, we recommend you to only perform a target audit to save money and time and focus more on this specific target’s detail.

output:

  • specific facility, process, equipment, premises Audit
  • Audit report
  • Deviation/nonconformity identification
  • Follow up

Third-party audit

These days preparing the whole manufacturing facilities including all premises, equipment, and personnel is difficult, costly, and complex. subsequently, manufacturers prefer to start their business and outsourcing other needs such as tests, training programs and courses, distributing, quality control unit, etc.

The most concern of outsourcing is how to be sure that all processes in the third-party company comply with standards because incompliance could affect the quality of your product.

In this situation, we will join you and perform periodic audits on behalf of your company.

Output:

  • Third-party audit
  • Providing audit checklist
  • Providing audit report
  • Identifying deviation
  • Follow up CAPA handling

Audit procedure

GMP pre-audits to comply with GMP requirements

Our company will assist you and your company to get ready for local and international regulatory inspection by performing pre audits according to EU, FDA, and IFDA requirements.

Treata Padideh Sanat can perform such a GMP audit for the following product type:

  • Pharmaceutical products
  • Cosmetics
  • Clinical devices

Audits and Reports

Each audit depends on your demand and need will be different but typically takes one to two days and include:

  • whole company and site visit and checking quality management system, equipment, material, process and production control, labeling and packaging, quality control and laboratory, etc.
  • Documents and qualification review including batch records, internal audit reports, standard operational procedures, training programs, and certificates.
  • Technical interview from in-charge personnel while auditing to make sure they are ready for being inspected and find gaps.

after audit completion, we provide a detailed report including:

  • GMP audit checklist which consists of all required parameters that should be obtained
  • Gap analysis form in which our auditors list all Deviation / Nonconformity as well as positive points.

Gap Analysis Form

All Deviation / Nonconformity categorized into 4 types due to risk assessment according to WHO guideline:

  • Critical deviations

 if a deviation has an impact on product quality, process parameters, or equipment used in the process, of which the risk of patient safety is high, the deviation categorized in this group and should be identified and implement effective corrective action.

  • Major deviation

 if a deviation has an impact on product quality, process parameters, or equipment used in the process, of which the risk of patient safety is unlikely, the deviation categorized in this group and should be identified and implement effective corrective actions.

  • Minor deviation

 if a deviation has no impact on product quality, process parameters, or equipment used in the process, the deviation categorized in this group and recommended to handle and control it.

  • Recommendation

 Our auditors will recommend some points to improve a system and comply more with GMP standard.

  • Positive Points

 Due to guidelines, the best auditing is mentioning positive points as well as negatives. as a result, we provide you this list to motivate and bold your attempts.

Providing effective Corrective/preventive actions

After providing a gap analysis form, we will assist you to prioritize deviation/nonconformity and managing your budget and costs, besides, to comply with GMP requirements.

We gather a team of experienced and knowledgeable national and international expertise to make your company ready for local and international inspection to get your GMP approval.

Willing to assess your system’s GMP compliance, click the button below, and contact us for free advice.

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Our GxP Audit Services

Our GxP pre-audit services include:

  • GMP compliance assessment
  • Gap analysis
  • GAMP audit
  • cGMP audit
  • Risk assessment
  • GMP compliance assessment
  • GLP audit
  • GCP audit
  • Response to the regulatory audit report

Units Specific Audit

Units Audit

Depends on each companies size  and production will be different but typically includes:

  • Production
  • Quality Control
  • Quality Assurance
  • Technical Services
  • Storage & Warehouse

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