PSCI Audits

PSCI-Audits | Bureau Veritas

More transparency for the pharmaceutical industry

Resonsible procurement management and sustainable supplier relationships are becoming increasingly important for successful companies. Especially in a sector such as the pharmaceutical industry, which assumes a high level of social responsibility and must meet high quality standards, the systematic and sustainable design of the supply chain plays a particularly important role.

PSCI audits ensure greater transparency along the entire supply chain in the pharmaceutical industry. They ensure that manufacturers and suppliers of pharmaceutical products adhere to the principles of responsible supply chain management and thus contribute to sustainable and responsible procurement management.

NEWS: REMOTE AUDITS IN TIMES OF THE CORONA PANDEMIC

The corona crisis is currently causing great uncertainty among many companies. Especially now, it is essential to maintain business activities in the best possible way while prioritizing the safety and health of staff and customers. This makes it all the more essential to consistently adhere to rules, regulations and standards - these are often required not only by law from the government, but also from business partners by contract. Bureau Veritas audit solutions help you maintain your certification on time. You can find all relevant information here: Remote Audits

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WHAT IS THE PHARMACEUTICAL SUPPLY CHAIN INITIATIVE (PSCI)?

The Pharmaceutical Supply Chain Initiative (PSCI) is an association of 30 companies from the pharmaceutical and healthcare industries. The PSCI was founded in 2006 in the USA as a non-profit organization and pursues the goal of continuous improvement of social, economic, environmental and occupational health and safety conditions along the entire supply chain in the pharmaceutical industry.

TO ENSURE RESPONSIBLE PROCUREMENT MANAGEMENT, PSCI HAS DEFINED 5 PRINCIPLES FOR THIS PURPOSE:

  • Ethics
  • Labour force
  • Health & Safety
  • Environmental protection
  • Management system

BUREAU VERITAS PSCI AUDITS | QUALITY IMPROVEMENT FOR SUPPLIERS AND CUSTOMERS

In the audits offered by Bureau Veritas, companies in the pharmaceutical industry are audited according to an audit program specially developed by the PSCI. It ensures that pharmaceutical companies adhere to responsible procurement management. By carrying out the audit, suppliers and companies in the pharmaceutical industry ensure that they comply with the 5 PSCI principles - this ensures greater transparency, increases customer confidence and improves your company's image.

  • MORE TRANSPARENCY

    A PSCI audit provides more transparency along the entire supply chain in the pharmaceutical industry - this benefits manufacturers, suppliers, buyers and last but not least the end consumer

  • INCREASED TRUST

    A PSCI audit is based on the 5 principles of responsible procurement management - this increases your customers' trust in your company

  • HIGHER QUALITY

    PSCI audits offer opportunities for continuous improvement of your processes and performance targets - this increases the quality of your products

  • BETTER IMAGE

    With a PSCI audit you strengthen the image of your company and signal to your customers that you value a responsible and sustainable supply chain - this improves the relationship with your customers

FOR WHICH COMPANIES ARE PSCI AUDITS INTERESTING?

PSCI audits are generally of interest to many companies along the entire supply chain in the pharmaceutical industry. They not only offer advantages for the major manufacturers of drugs and medicines, but also for producers of preliminary products that are further processed in the downstream production of medicines.

The target group for which a PSCI audit is of interest and who benefit from it includes the following companies:

  • Manufacturers of medicines & pharmaceuticals
  • Producers & suppliers of pharmaceutical precursors
  • Companies from the fields of biotechnology, life sciences & pharmaceuticals
  • Generic drug manufacturers

FREQUENTLY ASKED QUESTIONS ABOUT PSCI AUDITS

WHAT NEEDS TO BE CONSIDERED BEFORE A PSCI AUDIT?

Before a PSCI audit can be carried out, the company or interested party should contact a PSCI-recognized certification company. Here the interested party receives a self-assessment questionnaire (SAQ), which he has to fill in. Then auditors are appointed, the audit team is put together and presented to the company. Once the company agrees with the auditors, the audit can be planned and carried out. Here you can download the PSCI audit registration form.

WHO OFFERS PSCI AUDITS?

PSCI audits can be carried out by certification companies that are recognised by the PSCI. Bureau Veritas is one of the seven recognized 3rd party audit companies worldwide that can perform PSCI audits.

WHAT DOES A PSCI AUDIT INVOLVE?

A PSCI audit is made up of the "Social Audit" and "HSE Audit". The social audit considers criteria that ensure that the company acts ethically and responsibly (e.g. compliance with minimum wage requirements, basic rights for employees, working conditions, social responsibility, etc.). The HSE audit considers criteria that ensure that the company complies with occupational health and safety requirements. A detailed overview of the contents and principles can be found in the document  "Guidance For Implementing The Principles" from the PSCI.

HOW LONG DOES A PSCI AUDIT TAKE?

The length of a PSCI audit depends on the size of the company. For small companies with up to 100 employees, a maximum of 10 employee interviews must be expected within the framework of the social audit and 1 day for the HSE audit. For larger companies with more than 1,000 employees and complex production facilities, a maximum of 40 employee interviews and 2-4 days for the HSE audit must be expected. Please contact us for more detailed information.

HOW OFTEN MUST THE AUDITS BE REPEATED?

The audits must be repeated in a cycle of 3 years to ensure that you continue to meet the requirements defined by the PSCI.

YOUR BENEFITS FROM PSCI AUDITS WITH BUREAU VERITAS

In particular, pharmaceutical companies with a Europe-wide or even global supplier or production network benefit from the cooperation with Bureau Veritas. As one of the world's leading PSCI audit providers, Bureau Veritas can quickly and efficiently deploy PSCI auditors in more than 140 countries. Bureau Veritas works exclusively with experienced auditors who have industry-specific know-how for the pharmaceutical industry.

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