GMP Certification | Good Manufacturing Practices

A GMP is a system for making sure that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

GMP is an abbreviation for Good Manufacturing Practices. GMP is an initiative of the WHO. The main aim of GMP is to see to it that the products are good sufficient for utilization after the final outcome. GMP governs the product at each and every step of manufacturing.

Good Manufacturing Practice (GMP) is that part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as essential by the marketing authorization (MA) or product specification. GMP is concerned with both production and quality control.

A Good Manufacturing Practices (GMP) certification scheme provides independent verification and certification that the basic manufacturing practices and prerequisites essential for the implementation of an efficient Hazard Analysis Critical Control Point (HACCP) food safety program are being followed.

Accreditation

Our accreditation means that we have been independently assessed as possessing the expertise and competency to audit and certify to each of the listed standards on our website.

  • THE EIGHT BENEFITS OF A CERTIFIED GMP.

    As an organisation, you can always choose to work in accordance with the GMP standard, but you can also choose to be certified by an independent party (such as a certification body). In practice, we see eight major benefits in choosing a certifiedGMP:

    1. You have objective proof that your organisation attaches great importance to quality and that you have it checked regularly by an independent party. This commitment increases confidence in your organisation.
    2. You achieve higher operating efficiency. Organisations that consider quality management to be an integral part of their business operations usually achieve a higher operating efficiency than those that do not.
    3. A certified GMPincreases the quality of your services and raises your staff’s awareness.
    4. A certified GMPensures clear processes and (communication) structures, tasks and responsibilities throughout the entire organisation. This increases the involvement of your staff, which improves the working atmosphere and reduces the pressure of work.
    5. You can detect and identify problems in good time, which means that you can quickly take steps to avoid the same mistakes in the future.
    6. You make it clear to your staff, your partners, your clients and the outside world that customer satisfaction is at the core of your business.
    7. A certified GMP gives you a positive company image, raising you up to the level of your competitors or perhaps even a level higher.
    8. It is possibly also in your commercial interest, seeing that more and more clients demand that their suppliers work in accordance with a certified GMP.

On the one hand, we see that organisations are often forced or feel obliged to implement a certified GMP. More and more clients demand that their suppliers work in accordance with the GMP standard.

On the other hand, we see that increasing numbers of organisations set up a certified GMPon their own initiative. These organisations want to become more professional and make the quality of their products and services clear, measurable and controllable in order to distinguish themselves from other suppliers.

In any case, the introduction of aGMP typically gives an organisation more order and structure, which is usually to the benefit of the quality of its products and services.

GMP: Certification Process

We certify numerous companies onGMP: on an annual basis. The process is very easy to follow into below basic steps.

* Apply for GMP: certification on application form & send application to Euro assessments

* We will review your application & generate an official proposal. This proposal will include all cost of GMP certification.

* Proposal acceptance

* Euro assessments will send you stage 1 audit plan & subsequently stage-1 audit will be conducted onsite as per plan.

* After successful stage 1 audit & closure of stage 1 non conformities (if any) we will send you stage 2 audit plan & stage 2 audit will be conducted accordingly.

 * After successful stage 2 audit & closure of stage 2 non conformities (if any), Lead auditor will recommend your organization for issuance of GMP certificate.

* Subsequently GMP certification decision is taken by Euro assessments as per its defined procedures &GMP: certificate is issued for your organization.

* Every year a surveillance audit is conducted to ensure continued adherence of your European Conformity to the requirements of GMP standard.

CONTACT US FOR MORE INFORMATION

Would you like more information about aGMP costing and the possibilities for your organisation? Then do not hesitate to contact us, without obligation.

Our team will be pleased to help you with preparing and implementing your quality management so that you can derive the ultimate benefit from the certification.

✓Eligibility for submitting tenders or proposals for projects.

✓Generates new business opportunities

✓Can boost your organisation’s brand reputation and be a useful promotional tool, especially when going up against competitors who aren’t certified

✓Attract investment and improve brand reputation

✓Improve corporate image. Project international quality in your services.

✓Increased customer confidence and satisfaction

✓Strengthen effectiveness and efficiency

✓Enhance internal effectiveness and improve productivity performance through elimination of unnecessary costs

✓Minimize corporate risk

✓Reduce information gaps

✓Supports address organizational risks and opportunities in a structured manner

✓Puts larger emphasis on leadership engagement

✓Is more user-friendly for service and knowledge-based organizations

✓Uses simplified language and a common structure and terms, which are mainly supportive to organizations using multiple management systems, like those for the environment, health & safety, or business continuity

✓Addresses supply chain management more efficiently

  1. Now that I have selected Euro Assessments, who will be my contact?

In the short term, you may continue to work with the Client Relations Manager who has been assisting you through the selection process. However, for audit-related information, your primary contact, and the person best equipped to help you will be your assigned lead auditor.

 

  1. What issues will my auditor be able to help me with?

Your assigned lead auditor is the point of contact for:

 

All of my audit scheduling.

✓ reviewing my documents prior to the Certification Audit.

✓ Coordinating and conducting my Certification Audit.

✓ Interpretations on my quality management system standard.

✓ Future site additions, location, upgrades, etc.

✓ most questions dealing with Euro Assessments and the audit process.

 

  1. What will my assigned lead auditor want to know when he/she makes initial contact with me?

Your assigned lead auditor will want to discuss your expected timing for the required certification activities such as document review and the initial assessment. He/she will need to know if you have elected to have a pre-assessment.

 

  1. If I am not sure when I want to schedule an auditing activity such as the document review or initial assessment how much notice does my assigned auditor need?

Your assigned lead auditor could be “booked” as far ahead as 3 to6 months or more. It is a good idea to “reserve” time on their schedule that is realistic and achievable. Should you cancel a scheduled time without ample notice, your assigned lead auditor may or may not be able to accommodate your needs. In that case, another lead auditor may be assigned to your account.

 

  1. What steps are there in the certification process?

There are 3 basic steps to a certification process and they are:

✓ Document review.

✓ Initial Assessment.

✓ Certification Panel Review of recommendation.

  1. What if I have a conflict during the audit process regarding an interpretation?

The process of resolving a conflict would be to:

✓ Work with your assigned lead auditor.

✓ conduct a joint phone call with your lead auditor and the Euro Assessments certification manager.

✓ lodge a formal complaint.

  1. What happens after my assigned lead auditor recommends my company for certification?

Your assigned lead auditor must finalize the audit report, gather all the evidence and submit the package to our office. The Certification Panel team reviews this information and the recommendation is then accepted or, rarely, rejected. If rejected, the auditor may require more information from you. After this process you will be informed by Euro Assessments of your certificate number. This process usually takes 5 working days after a recommendation is made.

 

  1. When will I receive a certificate?

Once the recommendation is accepted by the Certification Panel team you could expect your formal certificates in about 7 working days, which is approximately 2 weeks from the initial audit.

 

  1. Will there be a charge for my certificates?

Euro Assessments will provide two copies of the certificates at cost included in your certification cost. Additional copies may be obtained for an additional charge of $50 each.

 

  1. What happens if I want to change my certificate later?

Notify your assigned lead auditor of your intentions so that he/she can assess whether additional auditing is necessary. There may be a need to conduct an assessment, depending upon the significance of the changes. Any assessment activity will be charged at the rates in place at the time of the assessment. There is no charge to re-issue the certificate following changes.

Testimonials

Fair and use a practical approach to auditing which has aided in the development of a good working relationship between our organisations.” Leading IT Company

Mr. George

Auditors have a pragmatic approach. We find that the audit process benefits our organisation greatly and helps us to continually improve our quality. Leading Manufacturing Company

Mr. David Johnson

They executed the audit schedule in a timely and professional manner. We found the audits very rewarding. I would have no problem recommending Euro Assessments to any organisation considering certification.” Leading Logistic Company

Ms. Sarah James

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