EXCiPACT certification: A guide for manufacturers of pharmaceutical excipients

In the pharmaceutical industry, the quality of excipients plays a decisive role in the production of safe and effective medicines. The EXCiPACT standard was developed to ensure reliable quality and compliance with regulatory requirements. In this blog, you can find out what EXCiPACT certification means, how the process works and what benefits it offers.

What is EXCiPACT?

EXCiPACT is an internationally recognised certification standard developed specifically for manufacturers, suppliers and distributors of pharmaceutical excipients. The standard covers the requirements of GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) and offers a cost-efficient and independent certification system.

EXCiPACT certification enables companies to demonstrate their compliance with GMP and GDP standards without having to be repeatedly audited by pharmaceutical customers. It is recognised worldwide and is an effective way to create trust in the supply chain.

Why is EXCiPACT important?

Pharmaceutical companies rely on high-quality excipients to ensure the stability, safety and efficacy of their medicines. Faulty or contaminated excipients can pose significant risks to public health. EXCiPACT certification helps with this:

•  To strengthen quality assurance in the supply chain.
•  Reduce repeated audits by customers.
•  Improve market access, as many pharmaceutical companies rely on EXCiPACT-certified suppliers.
•  Ensure compliance with regulatory requirements (e.g. by the FDA or EMA).

How does EXCiPACT certification work?

Certification takes place in several steps. Here is an overview of the process:

1. preparation and analysis

• Understanding the standard: Companies must thoroughly study the requirements of the EXCiPACT standard. It includes specific guidelines for GMP and GDP.
• Gap analysis: A gap analysis helps to compare existing processes with the requirements and identify necessary changes.
• Defining the scope: Companies define which products, processes or locations are to be certified.

2. development of a quality system

• Quality management system (QMS): The company must develop or adapt a QMS that is EXCiPACT-compliant. This includes areas such as documentation, process control and risk management.
• Validation and traceability: Processes, devices and materials must be validated and complete traceability must be guaranteed.

3. training of the team

All employees involved in the production, storage and distribution of excipients must be trained. The focus here is on the requirements of the GMP and GDP guidelines.

4. internal audits

Prior to official certification, companies carry out internal audits to identify weaknesses and rectify deviations. These audits are an important prerequisite for EXCiPACT certification.

5. selection of a certification body

Companies must select an accredited certification body that specialises in EXCiPACT. The list of such bodies is available on the official EXCiPACT website.

6. certification audit

The audit is carried out in two phases:

1. Document review: The certification body reviews the documentation of the QMS.
2. On-site audit: Auditors visit the sites to check processes and procedures. Deviations are documented and must be corrected.

7. receipt of the certification

The EXCiPACT certificate is issued once the audit has been successfully completed and all deviations have been rectified. It is valid for three years and requires annual surveillance audits.

What are the advantages of EXCiPACT certification?

EXCiPACT certification brings numerous advantages:

1. Reduction of customer audits: Pharmaceutical companies often rely on EXCiPACT certification, which means that suppliers need to spend less time and resources on individual customer audits.
2. Improved market position: Certification enables companies to strengthen their credibility and set themselves apart from non-certified competitors.
3. Cost efficiency: EXCiPACT offers standardised certification that is significantly more cost-effective than repeated individual customer audits.
4. Compliance with legal requirements: Certification helps companies to fulfil the regulatory requirements in various markets (FDA, EMA, etc.).
5. Quality improvement: The implementation of an EXCiPACT-compliant management system improves internal processes, minimises risks and ensures product quality.

For whom is the EXCiPACT certification relevant?

EXCiPACT certification is aimed at companies involved in the manufacture, processing, storage or distribution of pharmaceutical excipients. This includes

• Manufacturers of auxiliary materials (e.g. binders, fillers, colourants).
• Distribution company.
• Storage and logistics service provider for pharmaceutical products.

Conclusion: A step towards quality assurance

EXCiPACT certification is a decisive milestone for companies that manufacture or distribute pharmaceutical excipients. It not only ensures increased quality and safety in the supply chain, but also enables more efficient collaboration with pharmaceutical customers. With the increasing importance of quality assurance and compliance, EXCiPACT is increasingly becoming a standard that companies around the world are adopting.

If you are in the pharmaceutical industry, EXCiPACT certification could be the key to taking your business to the next level. Start implementing now and secure your position as a trusted partner in the pharmaceutical supply chain.