Quality management

Qplus consult develops, implements, optimises and maintains your Quality Management System

Is your quality system in good shape?

An effective Quality Management System (QMS) helps you to develop a culture of quality, support data integrity, control suppliers and maintain overall compliance, ultimately contributing to patient’s health.  A QMS is a formalised system that documents policies, processes and procedures to ensure the integrity and quality of a product or service of a company. In life-sciences, Quality Management is a critical functionthat monitors quality and maintains compliance with regulatory requirements.

We help you build and maintain a strong quality culture that allows you to operate at the highest level of compliance.

Turn quality into a competitive and business advantage.

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Qplus consult develops and implements (a part of) your Quality Management, thereby ensuring the integrity and quality of your product

Development and implementation of a Quality Management System (QMS)

Building a Quality Management System (QMS) is quite a challenge for many companies. Qplus consult assists life-science companies with the development and implementation of a complete (or partial) QMS. Thanks to our experience, we ensure that your company owns a QMS that meets your needs and is in line with current Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) guidelines.
Contact us today for a free appointment.

Standard Operating Procedure (SOP), Work Instruction (WI) and forms

Standard Operating Procedures (SOP), Work Instructions (WI) and (workflow) forms are very important concepts in any industry, especially in life-sciences. They must be managed with strict Change Control processes to assure compliance with Good Practice (GxP) guidelines and regulations. This allows you to minimise variations and promote quality within the organisation, even if there are temporary or permanent personnel changes. Let our experts help you draft clear and readable documents making consistent delivery of high quality products possible.
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Qualified Person (QP) for EU product release

Releasing a product often means an enormous workload for your organisation and requires a Qualified Person (QP). Thanks to our experience, we can offer you adequate solutions to make the process run as quickly and efficiently as possible. Our experienced QP takes care of the technical, ethical and professional aspects and is concerned with the safety, quality and efficiency of the product in the interests of the patient.
Do you want assitance or more information? Contact us now for more information or a free appointment.

Responsible Person (RP) for Good Distribution Practice (GDP)

Qplus consult’s experts have the required training and qualifications to act as Responsible Person (RP) and can supervise your distribution activities, ensuring patient’s safety and your company’s reputation. Every distributor of medicinal products must appoint a RP who safeguards compliance to Good Distribution Practice (GDP) standards.
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Change Control process

Ad hoc changes made with the best intentions often result in chaos. Therefore a robust change control policy is required to guarantee that a change in process does not in any way change the quality of the finished product. Qplus consult makes sure your Change Control process is formalised ensuring that changes are introduced in a controlled and coordinated manner. This way you can reduce the chances of unauthorised alterations, disruption and errors in the system.
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Validation process

Effective process validation contributes significantly to assuring quality and allows you to always maintain the desired level of compliance. It is an ongoing process that must be frequently adapted. Qplus consult advises you during the implementation and execution of the validation process. Our experts will provide you with an efficient solution that will save you time and money.
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Product Quality Review

The purpose of Product Quality Reviews (PQR) is to verify the continuity of the existing process and the quality of the specifications for both the starting material and the end product. This way Marketing Authorisation Holders (MAH) and manufacturers can better understand processes and make further improvements. PQR are a source of valuable information and provide additional checks on production processes and quality requirements for your products.
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Implementation of global procedures and local legislation into local quality system

Most companies already have corporate policies and procedures that require implementation into the Quality Management System (QMS) of local affiliates. However, these policies and procedures may be incomplete, lacking specific detail, out of date, not integrated with other processes, or non-conform with local legislation. Our experts integrate applicable global policies and procedures into your local QMS making sure that they are up-to-date with current national laws and guidelines.
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Tailor made training: implementing a new Quality Management System (QMS)

After the development of a new quality system or after optimisation of the current one, training of your employees is necessary to make them familiar with new or adapted Standard Operating Procedures (SOP), Work Instructions (WI) and forms. Qplus consult has a lot of experience in training people employed in the (bio)pharmaceutical sector. This includes teaching them the importance of a Quality Management System (QMS) and how everyone is (partly) responsible for its implementation by correctly following the most recent SOP. We train your employees in the implementation of new procedures. Training can be given to one individual or groups up to 40 people.
Learn more about our training programs.

Quality Risk Management (QRM)

Quality Risk Management (QRM) is a systematic process for the assessment, control, communication and evaluation of risks to the quality of the medicinal product throughout its life cycle. Qplus consult can install an effective QRM process ensuring a high quality product protecting patient’s health. It also improves decision making when a quality problem occurs. Our experts can help you with your quality risk process.
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Deviation management

Deviations from established procedures incorporated in the Quality Management System (QMS) should be documented and investigated. Furthermore, Corrective and Preventive Actions (CAPA) should be taken to correct them and prevent reoccurrence. Correct management of deviations safeguards the quality of affected and future materials, products and/or procedures.
Customers and regulators will regularly audit your QMS to ensure that all anomalies are recorded, routed, analysed, and that you respond correctly in accordance with the associated Standard Operating Procedure (SOP). Qplus Consult takes care of adjustments, harmonisation and inspections of your existing SOP so that you comply with the worldwide procedures, and European and local legislation.
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Corrective and Preventive Action (CAPA) management

Corrective and Preventive Action (CAPA) management is the cornerstone of every Quality Management System (QMS). The necessity to create a CAPA may emerge after feedback from a client, audits, complaints, change controls, management review, Quality Risk Management, deviations or (self-)inspections. Our expert team can help you incorporate an effective CAPA management to correct and prevent (quality) problems by ensuring that your corrective action plans are aligned with the source of the issue.
Don’t hesitate to contact us for more information or a free appointment.

GDP quality management

The guideline on Good Distribution Practice (GDP) of medicinal products for human use sets out different requirements for wholesale distributors. One of them is maintaining a quality system that sets out the responsibilities, processes and risk management principles in relation to the wholesaler’s activities. Qplus consult helps you with the development and implementation of such quality system, making your distribution activities compliant with GDP requirements.
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