Audit | Audit Reports

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Primary packaging is an essential part of the pharmaceutical industry and plays a key role in protecting the quality and integrity of medicinal products. As the requirements for quality, safety and regulatory compliance in the pharmaceutical industry are extremely high, manufacturers of primary packaging materials must pass stringent audits. Working with an external auditor who has the necessary qualifications and training, we ensure that all relevant aspects of production and quality assurance are closely scrutinized. Our audit reports provide you with a detailed and transparent overview of the audited manufacturers and their production processes.

Our audit reports contain all relevant information on the following areas:

1. Manufacturing processes of primary packaging materials

• Review of the manufacturer's production processes to ensure that all processes meet the quality requirements.

2. Quality management systems (QMS)

• Determination of the conformity and effectiveness of the management system against the audit criteria.

• Identification of potential for improvement.

Our audit reports provide you with a sound, reliable basis for evaluating your suppliers of primary packaging materials. Through our thorough audits, you can ensure that your suppliers meet the highest quality standards and comply with regulatory requirements.

- Reliability and precision: Our audits are carried out in cooperation with an external, independent auditor who is specially trained and qualified for this type of audit. This provides you with accurate and comprehensible documentation to help you make decisions.

- Time and resource savings: With our audits already carried out, you save valuable time and resources as you have access to ready-made, precise audit reports.

- Regulatory assurance: Our audit reports give you the assurance that your suppliers comply with all relevant international standards, which is crucial for the safety and quality of your products.

- Optimization of supplier evaluation: With the detailed audit reports, you can evaluate your suppliers and ensure that your selection processes are based on a solid and objective foundation.

Manufacturer

Audit criteria

Audit type

Country

Production site

Date

Datwyler Pharma Packaging Belgium NV ISO 9001:2015, 15378:2017; System documentation, customer requirements, product specific requirements Supplier audit (2nd party audit); Supplier qualification Belgium Alken 05/2024
Datwyler Pharma Packaging Germany GmbH ISO 9001:2015, 15378:2017; System documentation, customer requirements, product specific requirements Supplier audit (2nd party audit); Supplier qualification Germany Karlsbad-Ittersbach 10/2022
Datwyler Pharma Packaging Italy SRL ISO 9001:2015, 15378:2017; System documentation, customer requirements, product specific requirements Supplier audit (2nd party audit); Supplier qualification Italy Pregnana-Milanese 07/2024
           
Rofra GmbH ISO 9001:2015, 15378:2017; System documentation, customer requirements, product specific requirements Supplier audit (2nd party audit); Supplier qualification Germany Cursdorf 11/2022
           
SCHOTT Pharma AG & Co. KGaA ISO 9001:2015, 15378:2017; System documentation, customer requirements, product specific requirements Supplier audit (2nd party audit); Supplier qualification Germany Müllheim 04/2023
SCHOTT Pharma USA Inc. ISO 9001:2015, 15378:2017; System documentation, customer requirements, product specific requirements Supplier audit (2nd party audit); Supplier qualification US Lebanon, PA 01/2023
           
SGD Kipfenberg GmbH ISO 9001:2015, 15378:2017; System documentation, customer requirements, product specific requirements Supplier audit (2nd party audit); Supplier qualification Germany Kipfenberg 09/2024
SGD Saint-Quentin-Lamotte ISO 9001:2015, 15378:2017; System documentation, customer requirements, product specific requirements Supplier audit (2nd party audit); Supplier qualification France Saint-Quentin-Lamotte 09/2024
SGD Sucy-en-Brie ISO 9001:2015, 15378:2017; System documentation, customer requirements, product specific requirements Supplier audit (2nd party audit); Supplier qualification France Sucy-en-Brie 09/2024
           
West Pharmaceutical Services Beograd d.o.o. Kovin ISO 9001:2015, 15378:2017; System documentation, customer requirements, product specific requirements Supplier audit (2nd party audit); Supplier qualification Serbia Kovin 11/2022
West Pharmaceutical Services Germany, GmbH & Co. KG ISO 9001:2015, 15378:2017; System documentation, customer requirements, product specific requirements Supplier audit (2nd party audit); Supplier qualification Germany Eschweiler 05/2023
West Pharmaceutical Services Germany, GmbH & Co. KG ISO 9001:2015, 15378:2017; System documentation, customer requirements, product specific requirements Supplier audit (2nd party audit); Supplier qualification Germany Stolberg 05/2023
West Pharmaceutical Services France S.A. ISO 9001:2015, 15378:2017; System documentation, customer requirements, product specific requirements Supplier audit (2nd party audit); Supplier qualification France Le Nouvion-en-Thiérache Le Nouvion-en-Thiérache in planning
West Pharmaceutical Services, Inc. ISO 9001:2015, 15378:2017; System documentation, customer requirements, product specific requirements Supplier audit (2nd party audit); Supplier qualification US Jersey Shore, PA 01/2023
West Pharmaceutical Services Singapore Pte Ltd. ISO 9001:2015, 15378:2017; System documentation, customer requirements, product specific requirements Supplier audit (2nd party audit); Supplier qualification Singapore Jurong in planning

Contact us to find out more about the audit reports available and how they can help you ensure the quality and regulatory compliance of your primary packaging suppliers.

Interesting facts about GMP audits

A GMP audit is a detailed examination of a manufacturer or supplier to determine whether all relevant GMP requirements are being met. This includes the analysis of production processes, quality assurance, personnel qualifications, equipment and documentation. Audits can be carried out both internally (by a company itself) and externally (by independent testing organizations, customers or authorities).

The aim of a GMP audit is to ensure that medicinal products are manufactured to the highest quality standards in order to guarantee the safety of the end user.

The performance of GMP audits pursues several central objectives:

1. Verification of compliance with regulatory requirements: Audits ensure that all relevant legal and regulatory requirements, as defined by regulatory authorities such as the FDA (Food and Drug Administration) in the USA or the EMA (European Medicines Agency) in Europe, are complied with.

2. Identification of process deficiencies: Audits help to identify weaknesses in the production process that could potentially affect the quality or safety of products. This includes problems in the manufacture, storage or packaging of medicinal products.

3. Promotion of continuous improvement: Audits provide an opportunity to review existing processes and identify potential for improvement. This supports the continuous improvement of quality assurance and production processes.

4. Risk management: By identifying deviations or weaknesses in the system, risks can be proactively managed and, if necessary, preventive measures can be taken to avoid future quality problems.

There are different types of GMP audits, which are carried out depending on the objective and context:

1. Internal audits: These audits are conducted by the company's own organization to ensure that all internal processes comply with GMP requirements. They are an important part of quality management and are used for self-monitoring and continuous improvement.

2. External audits: External audits are carried out by third parties, such as customers, certification bodies or regulatory authorities. They check whether a company applies the GMP guidelines correctly and fulfills the requirements of the regulatory authorities.

3. Supplier audits: These audits are designed to check the compliance of suppliers and service providers. In the pharmaceutical industry, it is crucial that suppliers of raw materials and packaging materials also comply with GMP standards. Supplier audits can help to identify risks in the supply chain at an early stage.

4. Regulatory audits: Regulatory authorities such as the FDA or EMA conduct audits to ensure compliance with legal regulations and GMP standards. Such an audit can also influence the approval of a company to manufacture and market medicinal products.

A GMP audit follows a clearly structured procedure:

1. Audit preparation: In this phase, the audit plan is drawn up, defining the areas to be audited, objectives and the timeframe of the audit. All relevant documents and records are reviewed to ensure that all necessary information is available for the audit.

2. Conducting the audit: The actual audit includes an inspection of the production facilities, laboratories and quality assurance facilities. It checks whether all manufacturing processes, documentation and staff training comply with GMP requirements. In addition, interviews are conducted with staff to check how well the GMP requirements are implemented in day-to-day operations.

3. Reporting: After the audit, the auditor prepares a detailed report summarizing the results. The report contains both identified deficiencies and strengths of the system and makes recommendations for improvement. In many cases, deadlines are also set by which corrective action must be taken.

4. Follow-up: Follow-up is conducted after the audit to ensure that all recommended corrective and preventive actions are implemented. In many cases, a follow-up audit is carried out to check the effectiveness of the measures taken.

GMP audits are crucial for ensuring product quality and compliance with regulatory requirements. They offer companies the opportunity to identify and rectify weaknesses in the production process at an early stage before they lead to quality problems or legal consequences. They also ensure patient safety and trust in pharmaceutical products.

For the pharmaceutical industry, where errors can have serious consequences, GMP audits are essential to ensure and continuously improve the highest quality standards. They not only help with compliance, but also promote a culture of quality and safety throughout the organization.

GMP audits are an integral part of the pharmaceutical industry and make a decisive contribution to the safety, quality and efficacy of medicinal products. Regular and thorough audits ensure compliance with GMP requirements, minimize potential risks and promote the continuous improvement of production processes and quality management systems. They are not only an instrument for regulatory compliance, but also a key to effective and safe pharmaceutical production.

Learn more?

If you have any questions about our services in the area of audits, contact us by phone, email or live chat.