What is GMP Certification?
GMP stands for Good Manufacturing Practice. It is a system for ensuring 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.
How does GMP certification ensure good manufacturing practice?
The main objective of GMP certification of an organization is that such an organization complies with the stringent standards and practices for manufacturing of pharmaceutical products.
What are the procedures followed in GMP certification?
The following high-level steps are involved in getting a GMP certification:
- Application: A well laid out and complete application along with all relevant documentation should be submitted to IAS along with the processing fee. This should be submitted by a senior official of the company who has adequate knowledge of your manufacturing facilities and procedures followed in their company to avoid any discrepancies later on.
- In-house inspection: The application is then assessed for completeness, compliance requirements and the likelihood of certification based on all available information provided by you. Documentation on the company is then collected. This helps to further complete the application before an on-site assessment is carried out.
- On-site Assessment: An on-site visit is then carried out by IAS auditors of your facility so as to examine the system in place and verify applicant’s claims of conformance with GMP requirements. The auditors are assisted by your Quality Assurance personnel.
- Inspection report: A comprehensive inspection report with detailed observations is prepared for submission to IAS along with the certification fees.
- Evaluation of deficiencies: The deficiencies noted at your site during the on-site visit are evaluated. It is also decided whether you have adequately addressed these issues or not.
- Documentation of deficiencies: A deficiency meeting is arranged with the applicant to review the report and to ensure that all issues have been adequately addressed by them. It is also ensured that your system is ready for certification.
- Documents submission: Once all the deficiencies are accepted, a pre-certification inspection report is sent which summarizes all observations and deficiencies and how they have been addressed. The pre-certification report is also sent to the client with a request for action as needed. IAS will then send you a final certificate based on your response to this report, or let you know that an inspection needs to be carried out again as per the IAS standard process.
- Certification: The certificate is then issued to the company upon successful completion of all requirements.
When does GMP certification expire?
GMP Certification requires re-inspection at regular intervals, which vary depending on risk assessment by IAS. The periodicity for re-certification inspections is between six months and two years. A facility may be inspected as soon as corrective actions are implemented for any non-conformance issues.
Is GMP certification required?
GMP certification is now becoming an industry standard for many industries, both nationally and internationally. All pharmaceutical manufacturers must now comply with the requirements of Annex 11 of the EU Falsified Medicines Directive. Annex 11 of the EU FMD basically specifies a list of requirements for certification, inspection and Good Manufacturing Practices (GMP) as a part of regulatory requirement to ensure that drugs are safe and effective. GMP is also mandatory in many other countries across the globe including Australia, Japan, Brazil etc.
What are the benefits of GMP certification?
The major benefits for getting a GMP certification are:
- Ensures compliance to international standards and laws/regulations.
- Enhances customer confidence in your product.
- Helps to win business from new customers not only domestically but also internationally.
- Can be used as a marketing tool to differentiate your product from that of competitors.
- Helps to create a brand image in the market.
GMP certification is complemented by quality management system certifications like ISO 9001, ISO 13485 etc. which are mandatory for certain industries across the world. However, it should be noted that these standards check performance, but it is the GMP certification (which comes under Annex 11) which ensures compliance with international requirements.
Is GMP certification expensive?
IAS is one of the most cost-effective solution providers in the industry, known for low fees and transparent invoicing. The fee structure at IAS is extremely user-friendly without any hidden charges. The cost depends on various factors like – number of batches manufactured at your facility, the production capacity etc.
Can IAS offer GMP certification in less than six months?
IAS has streamlined its GMP certification process to fast track requests from clients where possible. We can offer GMP certification within six months of submitting the application.
To know more about your GMP Certification, cost and its time line do not hesitate to contact us at [email protected]