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GDP Certification for Transportation Companies

For companies that don't store medicinal products for more than 72 hours but want to achieve a GDP certificate for their operation.

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Abbott
Roche
Pfizer

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Why choose PCS for GDP certification

  • Over 30 years of experience in GDP & pharma logistics
  • Team of regulatory and industry experts
  • We know what your clients expect in terms of GDP compliance
  • Experts in GDP implementation and certification

Looking for a partner in GDP certification?

Look no further! PCS helps clients achieve the desired quality by providing training, advising, and conducting checks. You can also contact us for voluntary GDP certification, ensuring your company complies with all GDP laws and regulations.

What is voluntary GDP certification?

Voluntary GDP certification allows companies that do not need a license but distribute medicines to demonstrate compliance with the high standards of Good Distribution Practices (GDP). This certification is recognized by both clients and suppliers and contributes to the integrity of the pharmaceutical supply chain.

Why choose voluntary GDP certification?

Medicines are produced to the highest standards, and distribution should be handled with equal care. Despite good intentions, mistakes can occur during distribution. Strict quality regulations like GDP are essential to ensure patient safety. By achieving voluntary GDP certification, your company demonstrates its commitment to the highest quality and safety in the distribution of pharmaceuticals.

What GDP services does PCS offer?

PCS supports companies with:

  • Implementing GDP requirements,

  • Preparing and submitting the certification application,

  • GDP inspection preparation,

  • Upgrading or implementing the GDP quality system,

  • Interim Responsible Person (RP) services.

Clients choose PCS because of our extensive experience in the field of GDP regulations. Time is always a factor in our projects. We know how the authorities work and what they expect. This way, we help our clients in the Netherlands achieve voluntary GDP certification on time and within budget.

Our GDP training certificates are widely known and accepted by industry and regulator alike. Thanks to our team of experienced consultants and former EU GDP inspectors, we can perform accurate pre-inspections and provide GDP audits for pharmaceutical distributors.

How does it work?

Achieving commercial (voluntary) GDP certification is a straightforward process. After an initial consultation, we will schedule an audit of your premises (if any), equipment (e.g., trucks), and quality system (if any).

Following this initial assessment, we will prepare a report highlighting any shortcomings or areas for improvement. Some recommendations may be voluntary, while others will be mandatory to achieve the GDP compliance level required for certification.

If desired, PCS can assist with or take full responsibility for upgrading your company to achieve EU GDP compliance.

Reporting & certification

When your company is ready for the final assessment, PCS will conduct a one-day (or half-day) audit of your company and quality system. During this audit, we will inspect all applicable GDP requirements and provide a detailed report with our findings.

For this report, we use the same system as national regulatory inspectorates. More information about this system is available further down this page.

If the assessment is successful, PCS will issue a GDP certificate. If not, an additional assessment will be conducted, followed by a revised report and certification.

If your company fails the additional assessment as well, PCS will no longer consider your company eligible for voluntary GDP certification.

Below is a detailed cost breakdown of voluntary GDP certification by PCS:

  • Phone Consultation and Scope Definition

    : €200

  • Initial Review

    : €600

  • Certification Audit

    : €1,500 per day

  • Report Preparation

    : €600

  • Certificate Issuance

    : €300

  • Recertification Audit

    : €1,500 per day (average of 0.5 day)

  • Additional Assessment (if initial result is insufficient)

    : €1,000

Recertification is available upon request. Typically, companies that have demonstrated compliance with EU GDP at the time of assessment build a reputation that no longer requires a voluntary GDP certificate. Clients and other stakeholders will recognize your name, commitment to quality, and reputation, reducing the need for the certificate itself.

Jaap Koster, CEO of PCS, avatar

Voluntary GDP certification is a testament to your commitment to quality and compliance, showcasing your dedication to maintaining high standards in pharmaceutical distribution.

Eng. J.J.M. Koster
CEO of PCS

Assessment scoring system

In EU Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) inspections, observations are categorized based on the severity of non-compliance. Here’s a brief explanation of each category and the passing criteria:

Minor Observations

  • Definition

    : Minor observations refer to small deviations from GMP or GDP guidelines that have a limited impact on product quality or safety.

  • Example

    : Minor documentation errors or slight deviations from standard operating procedures.

  • Impact

    : These observations generally do not pose a direct risk to patient safety.

  • Action Required

    : Typically, the company must correct these issues, but they do not usually prevent certification.

Major Observations

  • Definition

    : Major observations are significant deviations from GMP or GDP requirements that could potentially affect product quality or patient safety.

  • Example

    : Inadequate staff training, improper handling of materials, or significant documentation gaps.

  • Impact

    : These can have a substantial impact on the quality system and may pose a risk to patient safety.

  • Action Required

    : Corrective actions must be implemented promptly, and evidence of these actions must be provided. Re-inspection or additional documentation may be required before certification is granted.

Critical Observations

  • Definition

    : Critical observations indicate a serious breach of GMP or GDP guidelines that poses a direct and significant risk to patient safety or product quality.

  • Example

    : Falsification of records, severe contamination risks, or total lack of control over critical processes.

  • Impact

    : These observations represent an immediate threat and must be addressed urgently.

  • Action Required

    : Immediate corrective actions are necessary, and certification cannot be granted until these issues are fully resolved and verified through re-inspection.

Passing criteria for voluntary GDP certification by PCS

  • Minor Observations

    : Companies can still pass the inspection if only minor observations are noted, provided they commit to correcting these issues within a specified timeframe.

  • Major Observations

    : Certification can be delayed if major observations are noted. The company must address these observations and provide satisfactory evidence of corrective actions. A follow-up inspection may be required.

  • Critical Observations

    : Certification cannot be granted if critical observations are identified. Immediate corrective actions are required, and re-inspection is mandatory to ensure compliance before certification is awarded.

Notes on voluntary GDP xertification

It's important to note that voluntary GDP certificates do not carry regulatory weight. The only certifying body for the pharmaceutical industry in the Netherlands is Farmatec, the Dutch licensing agency under the Ministry of Health.

Neither PCS nor any other organization can issue GDP certificates that hold the same intent, significance, or validity as those issued by regulatory authorities.

Voluntary GDP certificates are intended solely to demonstrate to stakeholders that your company complies with GDP requirements at the time of assessment.

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Frequently asked questions

Why should my company pursue voluntary GDP certification?

Voluntary GDP certification showcases your commitment to quality and compliance, enhances your reputation among stakeholders, and helps ensure the integrity of your pharmaceutical distribution processes.

What distinguishes voluntary GDP certification from regulatory GDP certification?

Voluntary GDP certification is not mandated by regulatory authorities but serves to demonstrate a company's commitment to high standards in pharmaceutical distribution. It complements but does not replace the mandatory GDP certification issued by regulatory bodies like Farmatec.

How does voluntary GDP certification impact my company's operations and stakeholder perception?

Achieving voluntary GDP certification can significantly enhance your company’s reputation, demonstrating to clients, partners, and stakeholders that your operations meet high standards of quality and compliance. This can lead to increased trust and potential business opportunities. Often, transportation companies are requested by their clients to be GDP certified or achieve GDP certification. When you are not eligible for a government-issued GDP certificate, voluntary GDP certification can offer a solution.

What specific areas are evaluated during the voluntary GDP certification audit?

The audit covers various aspects including storage conditions, transportation, quality management systems, staff training, and documentation practices. Each area is assessed to ensure compliance with GDP guidelines and to identify areas for improvement.

Can voluntary GDP certification help my company prepare for regulatory inspections?

Yes, voluntary GDP certification can act as a preparatory step for regulatory inspections. It helps identify and rectify potential compliance issues beforehand, ensuring your company is well-prepared for official regulatory audits.

What are the typical challenges faced during the voluntary GDP certification process?

Common challenges include aligning current practices with GDP standards, maintaining consistent documentation, ensuring all staff are adequately trained, and managing the logistical aspects of compliance across multiple sites or distribution channels.

Let's get started!

We are a pharmaceutical consultancy dedicated to quality and patient safety. Do you have a GDP quality or regulatory problem, are you looking for a GDP certificate or clear GDP training? We have the expertise and experience to resolve it decisively and quickly. Feel free to contact us if you have any questions about our voluntary GDP certification or GDP in general.

  • Over 30 years of experience in GDP & pharma logistics
  • Team of regulatory and industry experts
  • We know what your clients expect in terms of GDP compliance
  • Experts in GDP implementation and certification
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